A Phase 4 interventional study of rhPTH (1-84) and Placebo in Hypoparathyroidism, sponsored by Shire. Completed at 40 sites in 13 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-06-09.
Sponsored by Shire (part of Takeda) · Phase 4, Interventional, and Treatment
Recombinant human parathyroid hormone, also known as if rhPTH(1-84), is a medicine to treat people with Hypothyroidism. The main aim of this study is to learn if rhPTH(1-84) can improve symptoms in adults with hypoparathyroidism.
In this study, participants will receive 1 of 2 treatments: rhPTH(1-84) or a placebo. A placebo looks like the medicine being studied but does not have medicine in it. In this study, the placebo will be a standard treatment which is either active Vitamin D, or active Vitamin D with calcium. Active Vitamin D is a form of vitamin D that has a faster effect on the body. These treatments will be given as a daily injection just under the skin. Participants will not know which treatment they received, nor will their study doctors. This is to help make sure the results are more reliable. All participants will also take active vitamin D and calcium supplements during treatment.
Participants will record their symptoms in a tool called the hypoparathyroidism symptom diary. This tool is used to assess symptoms and their impact and will give an overall score for each participant.
The study doctors will also check for side effects from the study treatments.
After treatment, researchers will check if there is any difference in the diary scores between the 2 treatment groups. A difference in score means there is a difference in symptoms and their impact. From this, researchers will learn if symptoms have improved for participants treated with rhPTH(1-84) compared with those treated with placebo.
24 SEPTEMBER 2020: The temporary enrollment stop of new patients into this study due to the COVID-19 pandemic has been lifted in one or more countries, and the study is now again enrolling new patients. However, some countries/sites may still have paused the enrollment of new patients due to the pandemic.
20 APRIL 2020: Enrollment of new patients into this study has been paused due to the COVID-19 situation. The duration of this pause is dependent on the leveling and control of the COVID-19 pandemic.
128 studies on the registry are indexed under Hypoparathyroidism; 30 are open to participants now.
This study's enrollment of 93 is above the median of 50 across 77 interventional studies indexed under Hypoparathyroidism.
Browse Hypoparathyroidism studies →Shire is the lead sponsor of 351 studies on the registry; 2 are open to participants now.
Of its 48 completed or terminated interventional studies of FDA-regulated products, 48 (100%) have results posted.
First submitted before Shire became part of Takeda.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Must be treated with active vitamin D (calcitriol or alfacalcidol) alone or in conjunction with calcium supplements for at least 4 months prior to the screening visit.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received placebo matched to rhPTH (1-84) as subcutaneous (SC) injection once daily (QD) with active vitamin D and calcium supplements up to 31.3 weeks.
Biological: Placebo
Participants received rhPTH (1-84) 50 microgram (mcg) SC injection QD, titrated within the dose range of 25-100 mcg QD as an adjunctive treatment with active vitamin D and calcium supplements based on metabolic response up to 32 weeks.
Biological: rhPTH (1-84)
rhPTH (1-84) SC injection.
Placebo QD SC injection.
Change From Baseline in Hypoparathyroidism Symptom Diary (HypoPT-SD) Symptom Subscale Score at Week 26
The HypoPT-SD is a 13-item patient-reported outcomes instrument that consists of the following items: symptom subscale (items 1-7), anxiety (item 8), sadness or depression (item 9) and impact subscale (items 10-13). For items 1-9, the individual score ranges from None=0 to Very severe=4; for items 10-13, it ranges from Not at all=0 to Very much=2. An item score was computed by taking the average of the daily item response over the 14-day period immediately before the visit. If data were not available for at least 4 out of 7 days during both 7-day periods within the 14-day period, the individual item score was set to missing. The symptom subscale score was computed as the average of symptom items 1-7 scores with more than 3 of the 7 symptom item scores were non-missing. Negative change in scores indicates improvement. A mixed model for repeated measures (MMRM) was used for analysis.
Time frame: Baseline, Week 26
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 26
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire contains 13 fatigue-related questions. The responses to the 13 items on the FACIT-Fatigue questionnaire are each measured on a 5-point Likert scale, where 0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit and 4=Very much. Thus, the total score ranges from 0 to 52. High scores represent less fatigue. A MMRM was used for analysis.
Time frame: Baseline, Week 26
Change From Baseline in Physical Component Summary (PCS) Derived From 36-Item Short Form Health Survey Version 2 (SF-36v2) Scores at Week 26
The SF-36 is a validated instrument that questions participants about perceived physical and mental health and function. The SF-36 consists of 8 scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight; the lower the score the more disability. Change in PCS derived from SF-36v2 at Week 26 was reported. A MMRM was used for analysis.
Time frame: Baseline, Week 26
Change From Baseline in Hypoparathyroidism Symptom Diary (HypoPT-SD) Impact Subscale Score at Week 26
The HypoPT-SD is a 13-item patient-reported outcomes instrument that consists of the following items: symptom subscale (items 1-7), anxiety (item 8), sadness or depression (item 9) and impact subscale (items 10-13). For items 1-9, the individual score ranges from None=0 to Very severe=4; for items 10-13, it ranges from Not at all=0 to Very much=2. An item score was computed by taking the average of the daily item response over the 14-day period immediately before the visit. If data were not available for at least 4 out of 7 days during both 7-day periods within the 14-day period, the individual item score was set to missing. The impact subscale score was computed as the average of impact items 10-13 scores with no impact item score was non-missing. Negative change in scores indicates improvement. A MMRM was used for analysis.
Time frame: Baseline, Week 26
Change From Baseline in Individual Hypoparathyroidism Symptom Diary (HypoPT-SD) Impact Items Score at Week 26
The HypoPT-SD is a 13-item patient-reported outcomes instrument that consists of the following items: symptom subscale (items 1-7), anxiety (item 8), sadness or depression (item 9) and impact subscale (items 10-13). For items 1-9, the individual score ranges from None=0 to Very severe=4; for items 10-13, it ranges from Not at all=0 to Very much=2. An item score was computed by taking the average of the daily item response over the 14-day period immediately before the visit. If data were not available for at least 4 out of 7 days during both 7-day periods within the 14-day period, the individual item score was set to missing. The change in individual symptom item scores was reported. Negative change in scores indicates improvement. MMRM was used for analysis.
Time frame: Baseline, Week 26
Change From Baseline in Hypoparathyroidism Symptom Diary (HypoPT-SD) Symptom Item Anxiety (Item 8) Score at Week 26
The HypoPT-SD is a 13-item patient-reported outcomes instrument that consists of the following items: symptom subscale (items 1-7), anxiety (item 8), sadness or depression (item 9) and impact subscale (items 10-13). For items 1-9, the individual score ranges from None=0 to Very severe=4; for items 10-13, it ranges from Not at all=0 to Very much=2. The anxiety item score was computed by taking the average of the daily item response over the 14-day period immediately before the visit. If data were not available for at least 4 out of 7 days during both 7-day periods within the 14-day period, the anxiety item score was set to missing. Negative change in scores indicates improvement. MMRM was used for analysis.
Time frame: Baseline, Week 26
Change From Baseline in Hypoparathyroidism Symptom Diary (HypoPT-SD) Symptom Item Sadness or Depression (Item 9) Score at Week 26
The HypoPT-SD is a 13-item patient-reported outcomes instrument that consists of the following items: symptom subscale (items 1-7), anxiety (item 8), sadness or depression (item 9) and impact subscale (items 10-13). For items 1-9, the individual score ranges from None=0 to Very severe=4; for items 10-13, it ranges from Not at all=0 to Very much=2. The sadness or depression item score was computed by taking the average of the daily item response over the 14-day period immediately before the visit. If data were not available for at least 4 out of 7 days during both 7-day periods within the 14-day period, the item score was set to missing. Negative change in scores indicates improvement. MMRM was used for analysis.
Time frame: Baseline, Week 26
Change From Baseline in Individual Hypoparathyroidism Symptom Diary (HypoPT-SD) Symptom Item Scores at Week 26
The HypoPT-SD is a 13-item patient-reported outcomes instrument that consists of the following items: symptom subscale (items 1-7), anxiety (item 8), sadness or depression (item 9) and impact subscale (items 10-13). For items 1-9, the individual score ranges from None=0 to Very severe=4; for items 10-13, it ranges from Not at all=0 to Very much=2. An item score was computed by taking the average of the daily item response over the 14-day period immediately before the visit. If data were not available for at least 4 out of 7 days during both 7-day periods within the 14-day period, the individual item score was set to missing. Negative change in scores indicates improvement. MMRM was used for analysis.
Time frame: Baseline, Week 26
Number of Participants With Response at Week 26 [Early Termination (ET)]
Response was defined as a 30% reduction in HypoPT-SD symptom subscale score from baseline. The HypoPT-SD is a 13-item patient-reported outcomes instrument that consists of the following items: symptom subscale (items 1-7), anxiety (item 8), sadness or depression (item 9) and impact subscale (items 10-13). For items 1-9, the individual score ranges from None=0 to Very severe=4; and for items 10-13, it ranges from Not at all=0 to Very much=2. An item score was computed by taking the average of the daily item response over the 14-day period immediately before the visit. If data were not available for at least 4 out of 7 days during both 7-day periods within the 14-day period, the individual item score was set to missing. The symptom subscale score was computed as the average of symptom items 1-7 scores with more than 3 of the 7 symptom item scores were non-missing. Data reported also includes results for early terminated participants.
Time frame: Baseline up to Week 26
Change From Baseline in the Most Bothersome Symptom Score at Week 26
The HypoPT-SD is a 13-item patient-reported outcomes instrument that consists of the following items: symptom subscale (items 1-7), anxiety (item 8), sadness or depression (item 9) and impact subscale (items 10-13). For items 1-9, the individual score ranges from None=0 to Very severe=4 and for items 10-13, it ranges from Not at all=0 to Very much=2. An item score was computed by taking the average of the daily item response over the 14-day period immediately before the visit. If data were not available for at least 4 out of 7 days during both 7-day periods within the 14-day period, the individual item score was set to missing. The Most Bothersome Symptom Score was analyzed. Negative change in scores indicates improvement. MMRM was used for analysis.
Time frame: Baseline, Week 26
Change From Baseline in Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) Perceived Cognitive Impairments (PCI) Score at Week 26
The Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) assessment is a 37-item instrument. The perceived cognitive impairment and the impact on quality of life domains were assessed in this study. These 2 domains include 22 items rated on a 5-point scale. The perceived cognitive impairments subscale contains 18 items and each item has a 5-point ordinal response scale (0=Never, 1= About once a week, 2 = Two to three times a week, 3= Nearly every day, 4 = Several times a day). Each item score is calculated as (4 minus item response), and the subscale score is \[sum of (4 minus item response)\]\*18/(number of items answered)\]. The perceived cognitive impairment subscale score ranges from 0 to 72, with higher scores indicate better cognitive function. A MMRM was used for analysis.
Time frame: Baseline, Week 26
Change From Baseline in Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) Impact on Quality of Life (QoL) Score at Week 26
The Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) assessment is a 37-item instrument. The perceived cognitive impairment and the impact on quality of life domains were assessed in this study. These 2 domains include 22 items rated on a 5-point scale. The impact on quality of life domain contains 4 items and each item has a 5-point ordinal response scale (0=Never, 1= About once a week, 2 = Two to three times a week, 3= Nearly every day, 4 = Several times a day). Each item score is calculated as (4 minus item response), and the subscale score is \[sum of (4 minus item response)\]\*4/(number of items answered)\]. The impact on quality of life subscale score ranges from 0 to 16 with higher score indicates better cognitive function. A MMRM was used for analysis.
Time frame: Baseline, Week 26
Change From Baseline in Individual Domains of 36-Item Short Form Health Survey Version 2 (SF-36v2) at Week 26
The SF-36 is a validated instruments that question participants about perceived physical and mental health and function. The SF-36 consists of 8 scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight; the lower the score the more disability. Change in the score of individual domains of SF-36v2 at Week 26 was reported. A MMRM was used for analysis.
Time frame: Baseline, Week 26
Change From Baseline in Mental Component Summary (MCS) Score of 36-Item Short Form Health Survey Version 2 (SF-36v2) at Week 26
The SF-36 is a validated instruments that question participants about perceived physical and mental health and function. The SF-36 consists of 8 scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight; the lower the score the more disability. Change in the MCS of SF-36v2 at Week 26 was reported. A MMRM was used for analysis.
Time frame: Baseline, Week 26
Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Hypoparathyroidism (WPAI: Hypoparathyroidism) Score at Week 26
WPAI assessed impact of HypoPT on work productivity and daily activities. Concepts that WPAI: Hypoparathyroidism measures include time missed from work and impairment of work and other regular activities due to specific health problem (HypoPT). WPI was calculated based on 4 items including Q2: hours of work missed due to HPT; Q4: actual hours worked; Q5: HPT effect on productivity at work; Q6: HPT effect on daily activities. Scores for 4 subscales were calculated as Percent work time missed due to problem: Q2/(Q2+Q4)\*100; Percent impairment while working due to problem: Q5/10\*100; Percent overall work impairment due to problem: Q2/(Q2+Q4)+\[(1(Q2/(Q2+Q4)))x(Q5/10)\]\*100; Percent activity impairment due to problem: Q6/10\*100. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. Change from baseline in questionnaire response was reported. A MMRM was used for analysis.
Time frame: Baseline, Week 26
Change From Baseline in Scores of Patient's Assessment of Overall Health Status Using Patient Global Impression of Severity (PGI-S) at Week 26
The PGI-S is a global index that can be used to rate the severity of a specific condition. The PGI-S is a rating scale that asks the respondent to best describe how their symptoms severity. Response options are assessed as per 5-point scale: no symptoms (0), mild (1), moderate (2), severe (3), and very severe (4). Mean change in scores of PGI-S at Week 26 was reported. A MMRM was used for analysis.
Time frame: Baseline, Week 26
Change From Baseline in Scores of Patient's Assessment of Overall Health Status Using Patient Global Impression of Change (PGI-C) at Week 26
The PGI-C is verbal rating scale asks the respondent to best describe change in symptoms compared to the beginning of study. Response options are assessed using a 7-point scale: very much improved (0), much improved (1), minimally improved (2), no change (3), minimally worse (4), much worse (5), and very much worse (6). Negative change indicates improvement. Mean change in scores of PGI-C at Week 26 was be reported.
Time frame: Baseline, Week 26
Change From Baseline in In-Clinic Neurocognitive Assessment Scores at Week 24
Neurocognitive test battery included tests evaluating frontal-executive domain, which encompasses functions attributable to prefrontal cortex and its connections to basal ganglia (mostly striatum). Tests included the CogState (CS) Brief Battery (including the Detection: speed \[range from 2.001 to 6; lower scores (LS) indicate improvement (IMP)\], Identification: speed \[range from 2.001 to 6; LS indicate IMP\], One Card Learning: accuracy \[range from 0 to 1.5708; higher scores (HS) indicate IMP\], One Back: speed \[range from 2.001 to 6; LS indicate IMP\]), CS Groton Maze Learning Test: total errors (range from 0 to infinity; LS indicate IMP), CS International Shopping List Task (ISLT): number of correct responses (range from 0 to infinity; HS indicate IMP), and CS ISLT -Delayed Recall: number of correct responses (range from 0 to infinity; HS indicate IMP). Change in in-clinic neurocognitive assessment scores at Week 24 was reported. Analysis of Covariance (ANCOVA) was used for analysis.
Time frame: Baseline, Week 24
Change From Baseline in At-Home Neurocognitive Assessment Scores at Week 26
Neurocognitive test battery included tests evaluating frontal-executive domain, which encompasses functions attributable to prefrontal cortex and its connections to basal ganglia (mostly striatum). Tests included the CogState (CS) Brief Battery (including the Detection: speed \[range from 2.001 to 6; lower scores (LS) indicate improvement (IMP)\], Identification: speed \[range from 2.001 to 6; LS indicate IMP\], One Card Learning: accuracy \[range from 0 to 1.5708; higher scores (HS) indicate IMP\], One Back: speed \[range from 2.001 to 6; LS indicate IMP\]). Changes in at-home neurocognitive assessment scores (CS Brief Battery) at Week 26 was reported. A MMRM was used for analysis.
Time frame: Baseline, Week 26
Change From Baseline in 24-hour Urine Calcium Excretion at Week 26
Change in 24-hour urine calcium excretion at Week 26 was reported. A MMRM was used for analysis.
Time frame: Baseline, Week 26
Change From Baseline in Serum Phosphate Level at Week 26
Change in serum phosphate level at Week 26 was reported. A MMRM was used for analysis.
Time frame: Baseline, Week 26
Change From Baseline in Doses of Active Vitamin D at Week 26
Changes in doses of active vitamin D at Week 26 was reported. A MMRM was used for analysis.
Time frame: Baseline, Week 26
Change From Baseline in Doses of Calcium Supplements at Week 26
Changes in doses of calcium supplements at Week 26 was reported. A MMRM was used for analysis.
Time frame: Baseline, Week 26
Change From Baseline in Albumin-corrected Serum Calcium Control at Week 26
Change From Baseline in albumin-corrected serum calcium between 1.875 millimoles per liter (mmol/L) (7.5 milligram per deciliter \[mg/dL\]) and upper limit of normal (ULN) for the central laboratory normal range at Week 26 was reported.
Time frame: Week 26
Number of Participants Who Achieve Composite Criteria for Albumin-corrected Serum Calcium Concentration, Active Vitamin D Dose and Oral Elemental Calcium Supplement Dose at Week 26
Number of participants achieving composite criteria of the following: albumin-corrected serum calcium between 1.875 mmol/L (7.5 mg/dL) and the ULN for the central laboratory normal range, dose of active vitamin D decreased by 50% and at least a 50% reduction from the baseline oral elemental calcium supplement dose at Week 26 was reported.
Time frame: Week 26
Change From Baseline in Bone Turnover Marker Bone Specific Alkaline Phosphatase at Week 26
Bone turnover markers included serum bone-specific alkaline phosphatase, procollagen amino-terminal peptide, C-terminal telopeptide of type 1 collagen, and osteocalcin. A MMRM was used for analysis.
Time frame: Baseline, Week 26
Change From Baseline in Bone Turnover Marker Type I Collagen C-Telopeptides at Week 26
Bone turnover markers included serum bone-specific alkaline phosphatase, procollagen amino-terminal peptide, C-terminal telopeptide of type 1 collagen, and osteocalcin. A MMRM was used for analysis.
Time frame: Baseline, Week 26
Change From Baseline in Bone Turnover Marker Osteocalcin and Procollagen 1 N-Terminal Propeptide at Week 26
Bone turnover markers included serum bone-specific alkaline phosphatase, procollagen amino-terminal peptide, C-terminal telopeptide of type 1 collagen, and osteocalcin. A MMRM was used for analysis.
Time frame: Baseline, Week 26
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs are defined as AEs that started or worsened on or after the date and time of the first dose of investigational product.
Time frame: From start of study drug administration to 4 weeks post follow-up (up to Week 36)
Participants took part in the study at 35 investigative sites in Belgium, Canada, Denmark, Spain, France, United Kingdom, Italy, Netherlands, Norway, Portugal, Sweden and the United States (US) from 24 January 2018 to 19 May 2022.
| Milestone | Placebo | rhPTH (1-84) |
|---|---|---|
| Started | 48 | 45 |
| Completed | 46 | 39 |
| Not completed | 2 | 6 |
| Withdrew: Adverse event | 0 | 2 |
| Withdrew: Withdrawal by subject | 2 | 2 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Product recall | 0 | 1 |
The HypoPT-SD is a 13-item patient-reported outcomes instrument that consists of the following items: symptom subscale (items 1-7), anxiety (item 8), sadness or depression (item 9) and impact subscale (items 10-13). For items 1-9, the individual score ranges from None=0 to Very severe=4; for items 10-13, it ranges from Not at all=0 to Very much=2. An item score was computed by taking the average of the daily item response over the 14-day period immediately before the visit. If data were not available for at least 4 out of 7 days during both 7-day periods within the 14-day period, the individual item score was set to missing. The symptom subscale score was computed as the average of symptom items 1-7 scores with more than 3 of the 7 symptom item scores were non-missing. Negative change in scores indicates improvement. A mixed model for repeated measures (MMRM) was used for analysis.
| score on a scale | Placebo | rhPTH (1-84) |
|---|---|---|
| Change From Baseline in Hypoparathyroidism Symptom Diary (HypoPT-SD) Symptom Subscale Score at Week 26 | -0.93 ± 0.130 | -1.46 ± 0.137 |
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire contains 13 fatigue-related questions. The responses to the 13 items on the FACIT-Fatigue questionnaire are each measured on a 5-point Likert scale, where 0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit and 4=Very much. Thus, the total score ranges from 0 to 52. High scores represent less fatigue. A MMRM was used for analysis.
| score on a scale | Placebo | rhPTH (1-84) |
|---|---|---|
| Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 26 | 4.4 ± 1.87 | 15.0 ± 1.93 |
The SF-36 is a validated instrument that questions participants about perceived physical and mental health and function. The SF-36 consists of 8 scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight; the lower the score the more disability. Change in PCS derived from SF-36v2 at Week 26 was reported. A MMRM was used for analysis.
| score on a scale | Placebo | rhPTH (1-84) |
|---|---|---|
| Change From Baseline in Physical Component Summary (PCS) Derived From 36-Item Short Form Health Survey Version 2 (SF-36v2) Scores at Week 26 | 4.404 ± 1.3514 | 8.646 ± 1.3406 |
The HypoPT-SD is a 13-item patient-reported outcomes instrument that consists of the following items: symptom subscale (items 1-7), anxiety (item 8), sadness or depression (item 9) and impact subscale (items 10-13). For items 1-9, the individual score ranges from None=0 to Very severe=4; for items 10-13, it ranges from Not at all=0 to Very much=2. An item score was computed by taking the average of the daily item response over the 14-day period immediately before the visit. If data were not available for at least 4 out of 7 days during both 7-day periods within the 14-day period, the individual item score was set to missing. The impact subscale score was computed as the average of impact items 10-13 scores with no impact item score was non-missing. Negative change in scores indicates improvement. A MMRM was used for analysis.
| score on a scale | Placebo | rhPTH (1-84) |
|---|---|---|
| Change From Baseline in Hypoparathyroidism Symptom Diary (HypoPT-SD) Impact Subscale Score at Week 26 | -0.36 ± 0.076 | -0.69 ± 0.081 |
The HypoPT-SD is a 13-item patient-reported outcomes instrument that consists of the following items: symptom subscale (items 1-7), anxiety (item 8), sadness or depression (item 9) and impact subscale (items 10-13). For items 1-9, the individual score ranges from None=0 to Very severe=4; for items 10-13, it ranges from Not at all=0 to Very much=2. An item score was computed by taking the average of the daily item response over the 14-day period immediately before the visit. If data were not available for at least 4 out of 7 days during both 7-day periods within the 14-day period, the individual item score was set to missing. The change in individual symptom item scores was reported. Negative change in scores indicates improvement. MMRM was used for analysis.
| score on a scale | Placebo | rhPTH (1-84) |
|---|---|---|
| Impact on Sleep | -0.39 ± 0.086 | -0.68 ± 0.090 |
| Ability to Exercise | -0.35 ± 0.088 | -0.71 ± 0.093 |
| Ability to Complete Work | -0.39 ± 0.084 | -0.76 ± 0.089 |
| Impact Family Relationships | -0.29 ± 0.083 | -0.66 ± 0.088 |
The HypoPT-SD is a 13-item patient-reported outcomes instrument that consists of the following items: symptom subscale (items 1-7), anxiety (item 8), sadness or depression (item 9) and impact subscale (items 10-13). For items 1-9, the individual score ranges from None=0 to Very severe=4; for items 10-13, it ranges from Not at all=0 to Very much=2. The anxiety item score was computed by taking the average of the daily item response over the 14-day period immediately before the visit. If data were not available for at least 4 out of 7 days during both 7-day periods within the 14-day period, the anxiety item score was set to missing. Negative change in scores indicates improvement. MMRM was used for analysis.
| score on a scale | Placebo | rhPTH (1-84) |
|---|---|---|
| Change From Baseline in Hypoparathyroidism Symptom Diary (HypoPT-SD) Symptom Item Anxiety (Item 8) Score at Week 26 | -0.79 ± 0.139 | -1.35 ± 0.147 |
The HypoPT-SD is a 13-item patient-reported outcomes instrument that consists of the following items: symptom subscale (items 1-7), anxiety (item 8), sadness or depression (item 9) and impact subscale (items 10-13). For items 1-9, the individual score ranges from None=0 to Very severe=4; for items 10-13, it ranges from Not at all=0 to Very much=2. The sadness or depression item score was computed by taking the average of the daily item response over the 14-day period immediately before the visit. If data were not available for at least 4 out of 7 days during both 7-day periods within the 14-day period, the item score was set to missing. Negative change in scores indicates improvement. MMRM was used for analysis.
| score on a scale | Placebo | rhPTH (1-84) |
|---|---|---|
| Change From Baseline in Hypoparathyroidism Symptom Diary (HypoPT-SD) Symptom Item Sadness or Depression (Item 9) Score at Week 26 | -0.76 ± 0.137 | -1.30 ± 0.145 |
The HypoPT-SD is a 13-item patient-reported outcomes instrument that consists of the following items: symptom subscale (items 1-7), anxiety (item 8), sadness or depression (item 9) and impact subscale (items 10-13). For items 1-9, the individual score ranges from None=0 to Very severe=4; for items 10-13, it ranges from Not at all=0 to Very much=2. An item score was computed by taking the average of the daily item response over the 14-day period immediately before the visit. If data were not available for at least 4 out of 7 days during both 7-day periods within the 14-day period, the individual item score was set to missing. Negative change in scores indicates improvement. MMRM was used for analysis.
| score on a scale | Placebo | rhPTH (1-84) |
|---|---|---|
| Muscle Cramps | -0.91 ± 0.150 | -1.47 ± 0.158 |
| Tingling | -1.04 ± 0.146 | -1.58 ± 0.154 |
| Numbness | -0.89 ± 0.158 | -1.37 ± 0.167 |
| Muscle Spasms | -0.87 ± 0.149 | -1.49 ± 0.159 |
| Feelings of Heaviness | -0.96 ± 0.157 | -1.34 ± 0.166 |
| Physical Fatigue | -0.89 ± 0.155 | -1.45 ± 0.165 |
| Brain Fog | -0.90 ± 0.127 | -1.40 ± 0.134 |
Response was defined as a 30% reduction in HypoPT-SD symptom subscale score from baseline. The HypoPT-SD is a 13-item patient-reported outcomes instrument that consists of the following items: symptom subscale (items 1-7), anxiety (item 8), sadness or depression (item 9) and impact subscale (items 10-13). For items 1-9, the individual score ranges from None=0 to Very severe=4; and for items 10-13, it ranges from Not at all=0 to Very much=2. An item score was computed by taking the average of the daily item response over the 14-day period immediately before the visit. If data were not available for at least 4 out of 7 days during both 7-day periods within the 14-day period, the individual item score was set to missing. The symptom subscale score was computed as the average of symptom items 1-7 scores with more than 3 of the 7 symptom item scores were non-missing. Data reported also includes results for early terminated participants.
| Participants | Placebo | rhPTH (1-84) |
|---|---|---|
| Number of Participants With Response at Week 26 [Early Termination (ET)] | 24 | 25 |
The HypoPT-SD is a 13-item patient-reported outcomes instrument that consists of the following items: symptom subscale (items 1-7), anxiety (item 8), sadness or depression (item 9) and impact subscale (items 10-13). For items 1-9, the individual score ranges from None=0 to Very severe=4 and for items 10-13, it ranges from Not at all=0 to Very much=2. An item score was computed by taking the average of the daily item response over the 14-day period immediately before the visit. If data were not available for at least 4 out of 7 days during both 7-day periods within the 14-day period, the individual item score was set to missing. The Most Bothersome Symptom Score was analyzed. Negative change in scores indicates improvement. MMRM was used for analysis.
| score on a scale | Placebo | rhPTH (1-84) |
|---|---|---|
| Change From Baseline in the Most Bothersome Symptom Score at Week 26 | -0.87 ± 0.156 | -1.77 ± 0.174 |
The Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) assessment is a 37-item instrument. The perceived cognitive impairment and the impact on quality of life domains were assessed in this study. These 2 domains include 22 items rated on a 5-point scale. The perceived cognitive impairments subscale contains 18 items and each item has a 5-point ordinal response scale (0=Never, 1= About once a week, 2 = Two to three times a week, 3= Nearly every day, 4 = Several times a day). Each item score is calculated as (4 minus item response), and the subscale score is \[sum of (4 minus item response)\]\*18/(number of items answered)\]. The perceived cognitive impairment subscale score ranges from 0 to 72, with higher scores indicate better cognitive function. A MMRM was used for analysis.
| score on a scale | Placebo | rhPTH (1-84) |
|---|---|---|
| Change From Baseline in Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) Perceived Cognitive Impairments (PCI) Score at Week 26 | 2.7 ± 0.74 | 4.8 ± 0.76 |
The Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) assessment is a 37-item instrument. The perceived cognitive impairment and the impact on quality of life domains were assessed in this study. These 2 domains include 22 items rated on a 5-point scale. The impact on quality of life domain contains 4 items and each item has a 5-point ordinal response scale (0=Never, 1= About once a week, 2 = Two to three times a week, 3= Nearly every day, 4 = Several times a day). Each item score is calculated as (4 minus item response), and the subscale score is \[sum of (4 minus item response)\]\*4/(number of items answered)\]. The impact on quality of life subscale score ranges from 0 to 16 with higher score indicates better cognitive function. A MMRM was used for analysis.
| score on a scale | Placebo | rhPTH (1-84) |
|---|---|---|
| Change From Baseline in Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) Impact on Quality of Life (QoL) Score at Week 26 | 2.7 ± 0.74 | 4.8 ± 0.76 |
The SF-36 is a validated instruments that question participants about perceived physical and mental health and function. The SF-36 consists of 8 scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight; the lower the score the more disability. Change in the score of individual domains of SF-36v2 at Week 26 was reported. A MMRM was used for analysis.
| score on a scale | Placebo | rhPTH (1-84) |
|---|---|---|
| Standard-Bodily Pain | 4.194 ± 1.4987 | 11.404 ± 1.4919 |
| Standard-General Health | 3.515 ± 1.4509 | 9.061 ± 1.4463 |
| Standard-Mental Health | 3.719 ± 1.6098 | 11.576 ± 1.6043 |
| Standard-Physical Functioning | 4.833 ± 1.4850 | 9.387 ± 1.4669 |
| Standard-Role-Emotional | 5.228 ± 1.6322 | 13.648 ± 1.6254 |
| Standard-Role-Physical | 5.964 ± 1.5799 | 10.194 ± 1.5670 |
| Standard-Social Functioning | 6.005 ± 1.8636 | 9.814 ± 1.8661 |
| Standard-Vitality | 4.205 ± 1.6539 | 12.147 ± 1.6547 |
The SF-36 is a validated instruments that question participants about perceived physical and mental health and function. The SF-36 consists of 8 scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight; the lower the score the more disability. Change in the MCS of SF-36v2 at Week 26 was reported. A MMRM was used for analysis.
| score on a scale | Placebo | rhPTH (1-84) |
|---|---|---|
| Change From Baseline in Mental Component Summary (MCS) Score of 36-Item Short Form Health Survey Version 2 (SF-36v2) at Week 26 | 4.297 ± 1.5898 | 12.597 ± 1.5904 |
WPAI assessed impact of HypoPT on work productivity and daily activities. Concepts that WPAI: Hypoparathyroidism measures include time missed from work and impairment of work and other regular activities due to specific health problem (HypoPT). WPI was calculated based on 4 items including Q2: hours of work missed due to HPT; Q4: actual hours worked; Q5: HPT effect on productivity at work; Q6: HPT effect on daily activities. Scores for 4 subscales were calculated as Percent work time missed due to problem: Q2/(Q2+Q4)\*100; Percent impairment while working due to problem: Q5/10\*100; Percent overall work impairment due to problem: Q2/(Q2+Q4)+\[(1(Q2/(Q2+Q4)))x(Q5/10)\]\*100; Percent activity impairment due to problem: Q6/10\*100. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. Change from baseline in questionnaire response was reported. A MMRM was used for analysis.
| score on a scale | Placebo | rhPTH (1-84) |
|---|---|---|
| Percent Work Time Missed Due to Problem | 2.30 ± 6.279 | 5.43 ± 7.155 |
| Percent Impairment While Working Due to Problem | -11.7 ± 4.79 | -26.3 ± 5.76 |
| Percent Overall Work Impairment Due to Problem | -11.17 ± 3.854 | -26.08 ± 4.774 |
| Percent Activity Impairment Due to Problem | -10.2 ± 3.97 | -23.3 ± 4.17 |
The PGI-S is a global index that can be used to rate the severity of a specific condition. The PGI-S is a rating scale that asks the respondent to best describe how their symptoms severity. Response options are assessed as per 5-point scale: no symptoms (0), mild (1), moderate (2), severe (3), and very severe (4). Mean change in scores of PGI-S at Week 26 was reported. A MMRM was used for analysis.
| score on a scale | Placebo | rhPTH (1-84) |
|---|---|---|
| Change From Baseline in Scores of Patient's Assessment of Overall Health Status Using Patient Global Impression of Severity (PGI-S) at Week 26 | -0.8 ± 0.15 | -1.4 ± 0.16 |
The PGI-C is verbal rating scale asks the respondent to best describe change in symptoms compared to the beginning of study. Response options are assessed using a 7-point scale: very much improved (0), much improved (1), minimally improved (2), no change (3), minimally worse (4), much worse (5), and very much worse (6). Negative change indicates improvement. Mean change in scores of PGI-C at Week 26 was be reported.
| score on a scale | Placebo | rhPTH (1-84) |
|---|---|---|
| Change From Baseline in Scores of Patient's Assessment of Overall Health Status Using Patient Global Impression of Change (PGI-C) at Week 26 | -0.6 ± 1.04 | -1.7 ± 1.63 |
Neurocognitive test battery included tests evaluating frontal-executive domain, which encompasses functions attributable to prefrontal cortex and its connections to basal ganglia (mostly striatum). Tests included the CogState (CS) Brief Battery (including the Detection: speed \[range from 2.001 to 6; lower scores (LS) indicate improvement (IMP)\], Identification: speed \[range from 2.001 to 6; LS indicate IMP\], One Card Learning: accuracy \[range from 0 to 1.5708; higher scores (HS) indicate IMP\], One Back: speed \[range from 2.001 to 6; LS indicate IMP\]), CS Groton Maze Learning Test: total errors (range from 0 to infinity; LS indicate IMP), CS International Shopping List Task (ISLT): number of correct responses (range from 0 to infinity; HS indicate IMP), and CS ISLT -Delayed Recall: number of correct responses (range from 0 to infinity; HS indicate IMP). Change in in-clinic neurocognitive assessment scores at Week 24 was reported. Analysis of Covariance (ANCOVA) was used for analysis.
| score on a scale | Placebo | rhPTH (1-84) |
|---|---|---|
| Detection | 0.03 (0.01 to 0.06) | 0.05 (0.02 to 0.08) |
| Identification | 0.02 (-0.01 to 0.05) | 0.04 (0.01 to 0.07) |
| One Card Learning | 0.12 (0.07 to 0.16) | 0.13 (0.08 to 0.17) |
| One Back (ONB) | 0.09 (0.06 to 0.12) | 0.09 (0.06 to 0.13) |
| Groton Maze Learning (GML) | -2.43 (-9.89 to 5.02) | 7.49 (-0.46 to 15.45) |
| International Shopping List (ISL) | 1.98 (0.73 to 3.24) | 1.42 (0.08 to 2.76) |
| International Shopping List Test Delayed Recall (ISRL) | 1.31 (0.62 to 1.99) | 1.86 (1.13 to 2.59) |
Neurocognitive test battery included tests evaluating frontal-executive domain, which encompasses functions attributable to prefrontal cortex and its connections to basal ganglia (mostly striatum). Tests included the CogState (CS) Brief Battery (including the Detection: speed \[range from 2.001 to 6; lower scores (LS) indicate improvement (IMP)\], Identification: speed \[range from 2.001 to 6; LS indicate IMP\], One Card Learning: accuracy \[range from 0 to 1.5708; higher scores (HS) indicate IMP\], One Back: speed \[range from 2.001 to 6; LS indicate IMP\]). Changes in at-home neurocognitive assessment scores (CS Brief Battery) at Week 26 was reported. A MMRM was used for analysis.
| score on a scale | Placebo | rhPTH (1-84) |
|---|---|---|
| Detection (DET) | -0.01 (-0.03 to 0.00) | -0.01 (-0.03 to 0.01) |
| Identification (IDN) | -0.01 (-0.03 to 0.01) | 0.00 (-0.02 to 0.02) |
| One Card Learning (OCL) | 0.08 (0.05 to 0.11) | 0.09 (0.06 to 0.12) |
| One Back (ONB) | 0.02 (0.00 to 0.04) | 0.03 (0.01 to 0.05) |
Change in 24-hour urine calcium excretion at Week 26 was reported. A MMRM was used for analysis.
| millimoles per day (mmol/day) | Placebo | rhPTH (1-84) |
|---|---|---|
| Change From Baseline in 24-hour Urine Calcium Excretion at Week 26 | -1.99 ± 0.574 | 0.11 ± 0.651 |
Change in serum phosphate level at Week 26 was reported. A MMRM was used for analysis.
| millimoles per liter (mmol/L) | Placebo | rhPTH (1-84) |
|---|---|---|
| Change From Baseline in Serum Phosphate Level at Week 26 | 0.030 ± 0.0270 | -0.145 ± 0.0289 |
Changes in doses of active vitamin D at Week 26 was reported. A MMRM was used for analysis.
| micrograms per day (μg/day) | Placebo | rhPTH (1-84) |
|---|---|---|
| Change From Baseline in Doses of Active Vitamin D at Week 26 | -5.65 ± 3.155 | -1.57 ± 3.418 |
Changes in doses of calcium supplements at Week 26 was reported. A MMRM was used for analysis.
| milligrams per day (mg/day) | Placebo | rhPTH (1-84) |
|---|---|---|
| Change From Baseline in Doses of Calcium Supplements at Week 26 | -44.3 ± 91.13 | -375.6 ± 96.20 |
Change From Baseline in albumin-corrected serum calcium between 1.875 millimoles per liter (mmol/L) (7.5 milligram per deciliter \[mg/dL\]) and upper limit of normal (ULN) for the central laboratory normal range at Week 26 was reported.
| mmol/L | Placebo | rhPTH (1-84) |
|---|---|---|
| Change From Baseline in Albumin-corrected Serum Calcium Control at Week 26 | -0.033 ± 0.2072 | 0.090 ± 0.2254 |
Number of participants achieving composite criteria of the following: albumin-corrected serum calcium between 1.875 mmol/L (7.5 mg/dL) and the ULN for the central laboratory normal range, dose of active vitamin D decreased by 50% and at least a 50% reduction from the baseline oral elemental calcium supplement dose at Week 26 was reported.
| Participants | Placebo | rhPTH (1-84) |
|---|---|---|
| Number of Participants Who Achieve Composite Criteria for Albumin-corrected Serum Calcium Concentration, Active Vitamin D Dose and Oral Elemental Calcium Supplement Dose at Week 26 | 6 | 21 |
Bone turnover markers included serum bone-specific alkaline phosphatase, procollagen amino-terminal peptide, C-terminal telopeptide of type 1 collagen, and osteocalcin. A MMRM was used for analysis.
| units per liter (U/L) | Placebo | rhPTH (1-84) |
|---|---|---|
| Change From Baseline in Bone Turnover Marker Bone Specific Alkaline Phosphatase at Week 26 | 0.69 ± 2.256 | 23.03 ± 2.365 |
Bone turnover markers included serum bone-specific alkaline phosphatase, procollagen amino-terminal peptide, C-terminal telopeptide of type 1 collagen, and osteocalcin. A MMRM was used for analysis.
| nanograms per liter (ng/L) | Placebo | rhPTH (1-84) |
|---|---|---|
| Change From Baseline in Bone Turnover Marker Type I Collagen C-Telopeptides at Week 26 | -5.0 ± 76.52 | 780.5 ± 84.00 |
Bone turnover markers included serum bone-specific alkaline phosphatase, procollagen amino-terminal peptide, C-terminal telopeptide of type 1 collagen, and osteocalcin. A MMRM was used for analysis.
| micrograms per liter (µg/L) | Placebo | rhPTH (1-84) |
|---|---|---|
| Osteocalcin | -0.88 ± 4.109 | 55.55 ± 4.476 |
| Procollagen 1 N-Terminal Propeptide | 1.95 ± 22.744 | 228.52 ± 24.475 |
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs are defined as AEs that started or worsened on or after the date and time of the first dose of investigational product.
| Participants | Placebo | rhPTH (1-84) |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 46 | 41 |
Collected over From start of study drug administration to 4 weeks post follow-up (up to Week 36). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/48 (0%) | 6/48 (12.5%) | 41/48 (85.4%) |
| rhPTH (1-84) | 0/45 (0%) | 6/45 (13.3%) | 38/45 (84.4%) |
| Event | Placebo | rhPTH (1-84) |
|---|---|---|
| HypocalcaemiaMetabolism and nutrition disorders | 2/48 | 3/45 |
| HypercalcaemiaMetabolism and nutrition disorders | 2/48 | 0/45 |
| BradyphreniaPsychiatric disorders | 0/48 | 1/45 |
| GanglioneuromaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/48 | 1/45 |
| GastroenteritisInfections and infestations | 0/48 | 1/45 |
| HypersensitivityImmune system disorders | 0/48 | 1/45 |
| AnxietyPsychiatric disorders | 1/48 | 0/45 |
| SinusitisInfections and infestations | 1/48 | 0/45 |
| TetanyMetabolism and nutrition disorders | 1/48 | 0/45 |
| Event | Placebo | rhPTH (1-84) |
|---|---|---|
| HeadacheNervous system disorders | 11/48 | 14/45 |
| NauseaGastrointestinal disorders | 9/48 | 11/45 |
| HypocalcaemiaMetabolism and nutrition disorders | 9/48 | 5/45 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 6/48 | 8/45 |
| DiarrhoeaGastrointestinal disorders | 8/48 | 5/45 |
| NasopharyngitisInfections and infestations | 7/48 | 4/45 |
| ParaesthesiaNervous system disorders | 5/48 | 6/45 |
| DizzinessNervous system disorders | 6/48 | 5/45 |
| FatigueGeneral disorders | 4/48 | 5/45 |
| Feeling abnormalGeneral disorders | 1/48 | 5/45 |
Safety Analysis Set included all participants in the Intention-to-Treat (ITT) Set who took at least 1 dose of investigational product (study drug or placebo).
| Age, Continuous(years) | Placebo | rhPTH (1-84) | Total |
|---|---|---|---|
| Mean | 49.2 ± 12.16 | 47.8 ± 10.41 | 48.5 ± 11.31 |
| Sex: Female, Male(Participants) | Placebo | rhPTH (1-84) | Total |
|---|---|---|---|
| Female | 40 | 42 | 82 |
| Male | 8 | 3 | 11 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | rhPTH (1-84) | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 3 | 7 |
| Not Hispanic or Latino | 39 | 31 | 70 |
| Unknown or Not Reported | 5 | 11 | 16 |
| Race (NIH/OMB)(Participants) | Placebo | rhPTH (1-84) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 47 | 43 | 90 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Hypoparathyroidism Symptom Diary (HPT-SD/HypoPT-SD) Symptom Subscale Score at Baseline(score on a scale) | Placebo | rhPTH (1-84) | Total |
|---|---|---|---|
| Mean | 2.23 ± 0.541 | 2.56 ± 0.728 | 2.39 ± 0.657 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Data sharing details ↗ · vivli.org
Ran from Jan 2018 to primary completion in May 2022, 51 months.
Results were first posted in Jun 2023, 1 year after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Parathyroid Hormone