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TerminatedNCT03364738Updated Oct 7, 2022Results posted

Safety and Efficacy Study of rhPTH(1-84) in Subjects With Hypoparathyroidism

A Phase 3 interventional study of rhPTH(1-84) in Hypoparathyroidism, sponsored by Shire. Terminated at 10 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-07.

Sponsored by Shire (part of Takeda) · Phase 3, Interventional, and Treatment

Why this study was terminated
The study was terminated due to Takeda commercial Natpara recall.
Phase
Phase 3
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This study is open to adults with hypoparathyroidism who complete the SHP634-101 study (PARALLAX Study). The purpose of this study is to see if rhPTH(1-84) is safe and effective in adults with hypoparathyroidism who previously participated in the SHP634-101 study. All participants enrolled in this study will receive rhPTH(1-84) once-daily for 52 weeks via an injection.

Patients who complete the SHP634-101 study will have the option to screen for this extension study.

02

Conditions studied

  • Hypoparathyroidism

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03

In context

Hypoparathyroidism

121 studies on the registry are indexed under Hypoparathyroidism; 28 are open to participants now.

This study's enrollment of 22 is below the median of 52 across 72 interventional studies indexed under Hypoparathyroidism.

Browse Hypoparathyroidism studies →

Lead sponsor

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.

Browse Shire studies →All Takeda studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • An understanding, ability, and willingness to fully comply with study procedures and restrictions
  • Ability to voluntarily provide written, signed, and dated informed consent to participate in the study.
  • Previously completed the SHP634-101 (NCT02781844) study, including the 30-day follow-up.
  • Male or non-pregnant, non-lactating female subjects who agree to comply with applicable contraceptive requirements of the protocol or females of non-childbearing potential.

Exclusion criteria

Exclusion Criteria:

  • Received investigational study drug, aside from that received in study SHP634-101 (NCT02781844), within 3 months prior to the screening visit.
  • Presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine (with exception of the condition under study), or neurologic system(s) or psychiatric disease, that in the opinion of the investigator, would make the subject unsuitable for this study.
  • Received parathyroid hormone (PTH), PTH analog, or parathyroid hormone fragment 1-34 [PTH(1-34)] treatment within the last 30 days from the screening visit.
  • Subjects with a history of parathyroid hormone intolerance, based on investigator determination.
  • Any disease that might affect calcium metabolism or calcium-phosphate homeostasis as determined by the investigator other than hypoparathyroidism, including but not limited to, active hyperthyroidism; poorly controlled insulin-dependent diabetes mellitus or type 2 diabetes mellitus; severe and chronic cardiac, liver or renal disease; Cushing's syndrome; neuromuscular disease such as rheumatoid arthritis; myeloma; pancreatitis; malnutrition; rickets; recent prolonged immobility; active malignancy, bone metastases or a history of skeletal malignancies; primary or secondary hyperparathyroidism; a history of parathyroid carcinoma; hypopituitarism, acromegaly; or multiple endocrine neoplasia types 1 and 2 .
  • Subjects who are at increased baseline risk for osteosarcoma such as subjects with Paget's disease of bone or unexplained elevations of alkaline phosphatase, young adult subjects with open epiphyses, subjects with hereditary disorders predisposing to osteosarcoma or subjects with a prior history of external beam or implant radiation therapy involving the skeleton.

  • Use of the following medications prior to administration of investigational product within:

    1. 30 days-loop diuretics, lithium, systemic corticosteroids (medical judgment is required by the investigator. Primarily high doses of systemic corticosteroids [example (eg), prednisone] should be excluded. Stable doses of hydrocortisone [eg, as treatment for Addison's disease] may be acceptable).
    2. 3 months-cinacalcet hydrochloride
    3. 6 months-fluoride tablets, oral bisphosphonates, methotrexate, growth hormone, digoxin
    4. 12 months-intravenous bisphosphonates, drug or alcohol abuse, as determined by the investigator
  • Presence of any clinically significant results from laboratory tests, vital signs assessments, or electrocardiograms (ECG), that in the opinion of the investigator, would make the subject unsuitable for this study.
  • Any medical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for this study.
  • History of a clinically significant illness during the 4 weeks prior to dosing, that in the opinion of the investigator, would make the subject unsuitable for this study.
  • History of any clinically significant surgery or procedure within 8 weeks of first dose, as determined by the investigator or expected to undergo a major surgical procedure during the trial.
  • History of an allergic response(s) to PTH, PTH analogs, or PTH(1-34), or other clinically significant allergies, that in the opinion of the investigator, would make the subject unsuitable for this study.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    rhPTH(1-84)

    Participants will receive rhPTH(1-84) subcutaneous (SC) injection in the thigh (alternate thigh every day) once daily (QD) of an escalating dose from 50 microgram (mcg) to a maximum of 100 mcg increased in increments of 25 mcg no more frequently than every 2 to 4 weeks, with the goal of achieving or maintaining albumin-corrected serum calcium (ACSC) levels in the range of 2-2.25 millimoles per liter (mmol/L) (8.0-9.0 milligrams per deciliter \[mg/dL\]). Once a participant achieves a stable ACSC (2-2.25 mmol/L \[8.0-9.0mg/dL\]) and has minimized supplement doses, they will be maintained at that dose of rhPTH(1-84). If ACSC is greater than (\>) 2.25 mmol/L (\>9.0 mg/dL), a starting dose of 25 mcg will be administered.

    Biological: rhPTH(1-84)

Interventions

  • BiologicalrhPTH(1-84)

    Participants will receive rhPTH(1-84) SC injection in the thigh (alternate thigh every day) QD.

06

What researchers measure

Primary outcomes

  1. Percentage of Participants Who Achieved Total Albumin-corrected Serum Calcium (ACSC) Values Greater Than or Equal to (>=) to the Range of 7.5 mg/dL (1.875 mmol/L) and Less Than or Equal to (<=) Upper Limit of Normal (ULN) at Week 24

    Percentage of participants who achieved ACSC values \>= to range of 1.875 mmol/L and \<= ULN at Week 24 was reported.

    Time frame: At Week 24

  2. Percentage of Participants With Total ACSC Values >= to the Range of 7.5 mg/dL (1.875 mmol/L) and <=ULN at Week 52 (End-of-treatment [EOT])

    Percentage of participants who achieved ACSC values \>= to range of 1.875 mmol/L and \<= ULN at Week 52 (EOT) was reported.

    Time frame: At Week 52 (EOT)

  3. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs

    An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A Serious Adverse Event (SAE) was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, and is an important medical event. TEAEs were defined as AEs with a start date on or after the first dose of investigational product or a start date before the date of the first dose of investigational product that increased in severity or after the date of the first dose.

    Time frame: From start of study drug administration to end of study (Week 56)

  4. Number of Participants With Clinically Significant Change in Clinical Laboratory Values

    Clinical laboratory assessment included hematology, serum chemistry, urine chemistry and urinalysis. Clinical significance was judged by the investigator based upon the out of range values of standard range set for each parameter. Any changes in clinical laboratory results which were deemed clinically significant by the investigator was reported.

    Time frame: From start of study drug administration to end of study (Week 56)

  5. Number of Participants With Clinically Significant Change in Vital Sign

    Vital sign parameters included: temperature, pulse rate, respiration rate, systolic and diastolic blood pressure. Clinical significance was judged by the investigator based upon the out of range values of standard range set for each parameter. Any changes in vital signs which were deemed clinically significant by the investigator was reported.

    Time frame: From start of study drug administration to end of study (Week 56)

  6. Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Parameters

    Twelve-lead ECGs was performed in triplicate with a minimum 2-minute gap between traces. The participant rested in the supine position for at least 5 minutes before collecting the ECG. Assessment of ECG parameters included: heart rate, RR interval, PR interval, QRS interval, QT interval, and QTc interval. Clinical significance was judged by the investigator based upon the out of range values of standard range set for each parameter. Any change in ECG assessments which were deemed clinically significant by the investigator was reported.

    Time frame: From start of study drug administration to end of study (Week 56)

  7. Number of Participants With Clinically Significant Change in Estimated Glomerular Filtration Rate (eGFR) Values

    eGFR was calculated using the chronic kidney disease epidemiology (CDK-epi) formula. Clinical significance was judged by the investigator based upon the out of range values of standard range set for parameter. Any change in eGFR assessments which were deemed clinically significant by the investigator was reported.

    Time frame: From start of study drug administration to end of study (Week 56)

  8. Number of Participants With Clinically Significant Change in Serum Creatinine Value

    eGFR was assessed by measuring serum creatinine. Serum creatinine level was obtained directly from laboratory results. Clinical significance was judged by the investigator based upon the out of range values of standard range set for parameter. Any change in serum creatinine assessments which were deemed clinically significant by the investigator was reported.

    Time frame: From start of study drug administration to end of study (Week 56)

  9. Number of Participants With Positive Anti-Parathyroid Hormone Antibodies at Week 24

    Number of participants with positive anti-parathyroid hormone antibodies at Week 24 was reported.

    Time frame: Week 24

  10. Number of Participants With Positive Anti-Parathyroid Hormone Antibodies at Week 52 (EOT)

    Number of participants with positive anti-parathyroid hormone antibodies at Week 52 (EOT) was reported.

    Time frame: Week 52 (EOT)

Secondary outcomes

  1. Change From Baseline in Albumin Corrected Serum Calcium (ACSC) Concentration at Weeks 24 and 52 (EOT)

    Change from baseline in ACSC concentration at Weeks 24 and 52 (EOT) was reported.

    Time frame: Baseline, Weeks 24 and 52 (EOT)

  2. Change From Baseline in Serum Phosphate Concentration at Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT)

    Change from baseline in serum phosphate concentration at Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT) was reported.

    Time frame: Baseline, Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT)

  3. Change From Baseline in ACSC-phosphate Product at Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT)

    Change from baseline in ACSC-phosphate product at Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT) was reported. Here "mmol\^2/L\^2" is abbreviated as millimoles square per liter square.

    Time frame: Baseline, Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT)

  4. Change From Baseline in 24-hour Urine Calcium Excretion at Weeks 16, 32 and 52 (EOT)

    Change from baseline in 24-hour urine calcium excretion at Weeks 16, 32 and 52 (EOT) was reported.

    Time frame: Baseline, Weeks 16, 32 and 52 (EOT)

  5. Percentage Change From Baseline in Prescribed Supplemental Oral Calcium Dose at Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (End of Study [EOS])

    Percentage change from baseline in prescribed supplemental oral calcium dose at Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (EOS) were reported.

    Time frame: Baseline and at Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (EOS)

  6. Percentage Change From Baseline in Prescribed Supplemental Active Vitamin D Dose at Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (EOS)

    Percentage change from baseline in prescribed supplemental oral calcium dose at Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (EOS) were reported.

    Time frame: Baseline, Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (EOS)

  7. Percentage Change From Baseline in Serum Bone-specific Alkaline Phosphatase at Weeks 8, 24 and 52 (EOT)

    Percentage change from baseline in serum bone-specific alkaline phosphatase at Weeks 8, 24 and 52 (EOT) was reported.

    Time frame: Baseline, Weeks 8, 24 and 52 (EOT)

  8. Percentage Change From Baseline in Serum Osteocalcin at Weeks 8, 24 and 52 (EOT)

    Percentage change from baseline in serum osteocalcin at Weeks 8, 24 and 52 (EOT) was reported.

    Time frame: Baseline, Weeks 8, 24 and 52 (EOT)

  9. Percentage Change From Baseline in Procollagen 1 N-Terminal Propeptide at Weeks 8, 24 and 52 (EOT)

    Percentage change from baseline in procollagen 1 N-terminal propeptide at Weeks 8, 24 and 52 (EOT) was reported.

    Time frame: Baseline, Weeks 8, 24 and 52 (EOT)

  10. Percentage Change From Baseline in Type I Collagen C-Telopeptides at Weeks 8, 24 and 52 (EOT)

    Percentage change from baseline in type I collagen C-telopeptides at Week 8, 24 and 52 (EOT) was reported.

    Time frame: Baseline, Weeks 8, 24 and 52 (EOT)

  11. Percentage Change From Baseline in Type I Collagen N-Telopeptides at Weeks 8, 24 and 52 (EOT)

    Percentage change from baseline in type I collagen N-telopeptides at Week 8, 24 and 52 (EOT) was reported.

    Time frame: Baseline, Weeks 8, 24 and 52 (EOT)

07

Results

Posted Jun 16, 2021
Limitations and caveats
The study was terminated due to Takeda commercial Natpara recall.

Participant flow

Participants with hypoparathyroidism (HPT) who completed SHP634-101 (NCT02781844) study were eligible and enrolled in this extension study which was conducted at 10 sites in the United States, Denmark, Hungary and Canada between 26 September 2018 (first participant first visit) and 14 April 2020 (last participant last visit).

Participant flow — Overall Study
MilestonerhPTH(1-84)
Started22
Completed14
Not completed8
Withdrew: Early termination due to food and drug administration recall of rhpth(1-84) (natpara)6
Withdrew: Withdrawal by subject1
Withdrew: Adverse event1

Outcome measures

PrimaryPercentage of Participants Who Achieved Total Albumin-corrected Serum Calcium (ACSC) Values Greater Than or Equal to (>=) to the Range of 7.5 mg/dL (1.875 mmol/L) and Less Than or Equal to (<=) Upper Limit of Normal (ULN) at Week 24

Percentage of participants who achieved ACSC values \>= to range of 1.875 mmol/L and \<= ULN at Week 24 was reported.

Time frame:
At Week 24
Reported as:
Number · percentage of participants
Percentage of Participants Who Achieved Total Albumin-corrected Serum Calcium (ACSC) Values Greater Than or Equal to (>=) to the Range of 7.5 mg/dL (1.875 mmol/L) and Less Than or Equal to (<=) Upper Limit of Normal (ULN) at Week 24
percentage of participantsrhPTH(1-84)
Percentage of Participants Who Achieved Total Albumin-corrected Serum Calcium (ACSC) Values Greater Than or Equal to (>=) to the Range of 7.5 mg/dL (1.875 mmol/L) and Less Than or Equal to (<=) Upper Limit of Normal (ULN) at Week 24100
PrimaryPercentage of Participants With Total ACSC Values >= to the Range of 7.5 mg/dL (1.875 mmol/L) and <=ULN at Week 52 (End-of-treatment [EOT])

Percentage of participants who achieved ACSC values \>= to range of 1.875 mmol/L and \<= ULN at Week 52 (EOT) was reported.

Time frame:
At Week 52 (EOT)
Reported as:
Number · percentage of participants
Percentage of Participants With Total ACSC Values >= to the Range of 7.5 mg/dL (1.875 mmol/L) and <=ULN at Week 52 (End-of-treatment [EOT])
percentage of participantsrhPTH(1-84)
Percentage of Participants With Total ACSC Values >= to the Range of 7.5 mg/dL (1.875 mmol/L) and <=ULN at Week 52 (End-of-treatment [EOT])95.5 (0.772 to 0.999)
PrimaryNumber of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs

An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A Serious Adverse Event (SAE) was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, and is an important medical event. TEAEs were defined as AEs with a start date on or after the first dose of investigational product or a start date before the date of the first dose of investigational product that increased in severity or after the date of the first dose.

Time frame:
From start of study drug administration to end of study (Week 56)
Reported as:
Count of participants · Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
ParticipantsrhPTH(1-84)
Participants with TEAEs17
Participants with serious TEAEs4
PrimaryNumber of Participants With Clinically Significant Change in Clinical Laboratory Values

Clinical laboratory assessment included hematology, serum chemistry, urine chemistry and urinalysis. Clinical significance was judged by the investigator based upon the out of range values of standard range set for each parameter. Any changes in clinical laboratory results which were deemed clinically significant by the investigator was reported.

Time frame:
From start of study drug administration to end of study (Week 56)
Reported as:
Count of participants · Participants
Number of Participants With Clinically Significant Change in Clinical Laboratory Values
ParticipantsrhPTH(1-84)
Number of Participants With Clinically Significant Change in Clinical Laboratory Values0
PrimaryNumber of Participants With Clinically Significant Change in Vital Sign

Vital sign parameters included: temperature, pulse rate, respiration rate, systolic and diastolic blood pressure. Clinical significance was judged by the investigator based upon the out of range values of standard range set for each parameter. Any changes in vital signs which were deemed clinically significant by the investigator was reported.

Time frame:
From start of study drug administration to end of study (Week 56)
Reported as:
Count of participants · Participants
Number of Participants With Clinically Significant Change in Vital Sign
ParticipantsrhPTH(1-84)
Number of Participants With Clinically Significant Change in Vital Sign0
PrimaryNumber of Participants With Clinically Significant Change in Electrocardiogram (ECG) Parameters

Twelve-lead ECGs was performed in triplicate with a minimum 2-minute gap between traces. The participant rested in the supine position for at least 5 minutes before collecting the ECG. Assessment of ECG parameters included: heart rate, RR interval, PR interval, QRS interval, QT interval, and QTc interval. Clinical significance was judged by the investigator based upon the out of range values of standard range set for each parameter. Any change in ECG assessments which were deemed clinically significant by the investigator was reported.

Time frame:
From start of study drug administration to end of study (Week 56)
Reported as:
Count of participants · Participants
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Parameters
ParticipantsrhPTH(1-84)
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Parameters0
PrimaryNumber of Participants With Clinically Significant Change in Estimated Glomerular Filtration Rate (eGFR) Values

eGFR was calculated using the chronic kidney disease epidemiology (CDK-epi) formula. Clinical significance was judged by the investigator based upon the out of range values of standard range set for parameter. Any change in eGFR assessments which were deemed clinically significant by the investigator was reported.

Time frame:
From start of study drug administration to end of study (Week 56)
Reported as:
Count of participants · Participants
Number of Participants With Clinically Significant Change in Estimated Glomerular Filtration Rate (eGFR) Values
ParticipantsrhPTH(1-84)
Number of Participants With Clinically Significant Change in Estimated Glomerular Filtration Rate (eGFR) Values0
PrimaryNumber of Participants With Clinically Significant Change in Serum Creatinine Value

eGFR was assessed by measuring serum creatinine. Serum creatinine level was obtained directly from laboratory results. Clinical significance was judged by the investigator based upon the out of range values of standard range set for parameter. Any change in serum creatinine assessments which were deemed clinically significant by the investigator was reported.

Time frame:
From start of study drug administration to end of study (Week 56)
Reported as:
Count of participants · Participants
Number of Participants With Clinically Significant Change in Serum Creatinine Value
ParticipantsrhPTH(1-84)
Number of Participants With Clinically Significant Change in Serum Creatinine Value0
PrimaryNumber of Participants With Positive Anti-Parathyroid Hormone Antibodies at Week 24

Number of participants with positive anti-parathyroid hormone antibodies at Week 24 was reported.

Time frame:
Week 24
Reported as:
Count of participants · Participants
Number of Participants With Positive Anti-Parathyroid Hormone Antibodies at Week 24
ParticipantsrhPTH(1-84)
Number of Participants With Positive Anti-Parathyroid Hormone Antibodies at Week 240
SecondaryChange From Baseline in Albumin Corrected Serum Calcium (ACSC) Concentration at Weeks 24 and 52 (EOT)

Change from baseline in ACSC concentration at Weeks 24 and 52 (EOT) was reported.

Time frame:
Baseline, Weeks 24 and 52 (EOT)
Reported as:
Mean · mmol/L
Change From Baseline in Albumin Corrected Serum Calcium (ACSC) Concentration at Weeks 24 and 52 (EOT)
mmol/LrhPTH(1-84)
Change at Week 24-0.024 ± 0.2065
Change at Week 52 (EOT)-0.076 ± 0.1497
SecondaryChange From Baseline in Serum Phosphate Concentration at Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT)

Change from baseline in serum phosphate concentration at Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT) was reported.

Time frame:
Baseline, Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT)
Reported as:
Mean · mmol/L
Change From Baseline in Serum Phosphate Concentration at Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT)
mmol/LrhPTH(1-84)
Change at Week 4-0.167 ± 0.1816
Change at Week 8-0.124 ± 0.2252
Change at Week 16-0.107 ± 0.2583
Change at Week 24-0.160 ± 0.2303
Change at Week 32-0.089 ± 0.1809
Change at Week 40-0.121 ± 0.2542
Change at Week 52 (EOT)-0.114 ± 0.2590
SecondaryChange From Baseline in ACSC-phosphate Product at Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT)

Change from baseline in ACSC-phosphate product at Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT) was reported. Here "mmol\^2/L\^2" is abbreviated as millimoles square per liter square.

Time frame:
Baseline, Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT)
Reported as:
Mean · mmol^2/L^2
Change From Baseline in ACSC-phosphate Product at Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT)
mmol^2/L^2rhPTH(1-84)
Change at Week 4-0.31 ± 0.462
Change at Week 8-0.19 ± 0.537
Change at Week 16-0.16 ± 0.609
Change at Week 24-0.38 ± 0.556
Change at Week 32-0.29 ± 0.456
Change at Week 40-0.29 ± 0.572
Change at Week 52 (EOT)-0.34 ± 0.539
SecondaryChange From Baseline in 24-hour Urine Calcium Excretion at Weeks 16, 32 and 52 (EOT)

Change from baseline in 24-hour urine calcium excretion at Weeks 16, 32 and 52 (EOT) was reported.

Time frame:
Baseline, Weeks 16, 32 and 52 (EOT)
Reported as:
Mean · millimoles per day (mmol/day)
Change From Baseline in 24-hour Urine Calcium Excretion at Weeks 16, 32 and 52 (EOT)
millimoles per day (mmol/day)rhPTH(1-84)
Change at Week 16-0.22 ± 4.741
Change at Week 32-3.13 ± 4.103
Change at Week 52 (EOT)-2.53 ± 4.421
SecondaryPercentage Change From Baseline in Prescribed Supplemental Oral Calcium Dose at Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (End of Study [EOS])

Percentage change from baseline in prescribed supplemental oral calcium dose at Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (EOS) were reported.

Time frame:
Baseline and at Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (EOS)
Reported as:
Mean · percentage change
Percentage Change From Baseline in Prescribed Supplemental Oral Calcium Dose at Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (End of Study [EOS])
percentage changerhPTH(1-84)
Percentage change at Week 4-14.30 ± 34.269
Percentage change at Week 8-29.08 ± 38.019
Percentage change at Week 16-36.94 ± 45.665
Percentage change at Week 24-49.05 ± 49.049
Percentage change at Week 32-55.58 ± 44.268
Percentage change at Week 40-56.36 ± 45.168
Percentage change at Week 52 (EOT)-48.55 ± 45.237
SecondaryPercentage Change From Baseline in Prescribed Supplemental Active Vitamin D Dose at Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (EOS)

Percentage change from baseline in prescribed supplemental oral calcium dose at Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (EOS) were reported.

Time frame:
Baseline, Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (EOS)
Reported as:
Mean · percentage change
Percentage Change From Baseline in Prescribed Supplemental Active Vitamin D Dose at Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (EOS)
percentage changerhPTH(1-84)
Percentage change at Week 4-57.50 ± 40.995
Percentage change at Week 8-70.00 ± 39.217
Percentage change at Week 16-80.83 ± 27.185
Percentage change at Week 24-85.42 ± 25.055
Percentage change at Week 32-90.79 ± 17.324
Percentage change at Week 40-90.10 ± 18.564
Percentage change at Week 52 (EOT)-77.38 ± 43.870
SecondaryPercentage Change From Baseline in Serum Bone-specific Alkaline Phosphatase at Weeks 8, 24 and 52 (EOT)

Percentage change from baseline in serum bone-specific alkaline phosphatase at Weeks 8, 24 and 52 (EOT) was reported.

Time frame:
Baseline, Weeks 8, 24 and 52 (EOT)
Reported as:
Mean · percentage change
Percentage Change From Baseline in Serum Bone-specific Alkaline Phosphatase at Weeks 8, 24 and 52 (EOT)
percentage changerhPTH(1-84)
Percentage change at Week 829.90 ± 31.575
Percentage change at Week 2489.14 ± 54.452
Percentage change at Week 52 (EOT)94.08 ± 75.066
SecondaryPercentage Change From Baseline in Serum Osteocalcin at Weeks 8, 24 and 52 (EOT)

Percentage change from baseline in serum osteocalcin at Weeks 8, 24 and 52 (EOT) was reported.

Time frame:
Baseline, Weeks 8, 24 and 52 (EOT)
Reported as:
Mean · percentage change
Percentage Change From Baseline in Serum Osteocalcin at Weeks 8, 24 and 52 (EOT)
percentage changerhPTH(1-84)
Percentage change at Week 861.74 ± 68.363
Percentage change at Week 24225.91 ± 130.798
Percentage change at Week 52 (EOT)294.93 ± 215.100
SecondaryPercentage Change From Baseline in Procollagen 1 N-Terminal Propeptide at Weeks 8, 24 and 52 (EOT)

Percentage change from baseline in procollagen 1 N-terminal propeptide at Weeks 8, 24 and 52 (EOT) was reported.

Time frame:
Baseline, Weeks 8, 24 and 52 (EOT)
Reported as:
Median · percentage change
Percentage Change From Baseline in Procollagen 1 N-Terminal Propeptide at Weeks 8, 24 and 52 (EOT)
percentage changerhPTH(1-84)
Percentage change at Week 8119.98 ± 161.156
Percentage change at Week 24412.46 ± 248.423
Percentage change at Week 52 (EOT)476.07 ± 377.383
SecondaryPercentage Change From Baseline in Type I Collagen C-Telopeptides at Weeks 8, 24 and 52 (EOT)

Percentage change from baseline in type I collagen C-telopeptides at Week 8, 24 and 52 (EOT) was reported.

Time frame:
Baseline, Weeks 8, 24 and 52 (EOT)
Reported as:
Mean · percentage change
Percentage Change From Baseline in Type I Collagen C-Telopeptides at Weeks 8, 24 and 52 (EOT)
percentage changerhPTH(1-84)
Percentage change at Week 8124.62 ± 160.564
Percentage change at Week 24254.26 ± 198.947
Percentage change at Week 52 (EOT)227.13 ± 182.262
SecondaryPercentage Change From Baseline in Type I Collagen N-Telopeptides at Weeks 8, 24 and 52 (EOT)

Percentage change from baseline in type I collagen N-telopeptides at Week 8, 24 and 52 (EOT) was reported.

Time frame:
Baseline, Weeks 8, 24 and 52 (EOT)
Reported as:
Mean · percentage change
Percentage Change From Baseline in Type I Collagen N-Telopeptides at Weeks 8, 24 and 52 (EOT)
percentage changerhPTH(1-84)
Percentage change at Week 871.33 ± 99.933
Percentage change at Week 24183.23 ± 160.350
Percentage change at Week 52 (EOT)231.80 ± 270.229
PrimaryNumber of Participants With Positive Anti-Parathyroid Hormone Antibodies at Week 52 (EOT)

Number of participants with positive anti-parathyroid hormone antibodies at Week 52 (EOT) was reported.

Time frame:
Week 52 (EOT)
Reported as:
Count of participants · Participants
Number of Participants With Positive Anti-Parathyroid Hormone Antibodies at Week 52 (EOT)
ParticipantsrhPTH(1-84)
Number of Participants With Positive Anti-Parathyroid Hormone Antibodies at Week 52 (EOT)0

Adverse events

Collected over From start of screening up to end of study (Week 56). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
rhPTH(1-84)0/22 (0%)4/22 (18.2%)10/22 (45.5%)
Most frequent serious events
Most frequent serious events
EventrhPTH(1-84)
AppendicitisInfections and infestations1/22
Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/22
Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/22
Cerebellar haemorrhageNervous system disorders1/22
Most frequent other events
Showing 10 of 14
Most frequent other events
EventrhPTH(1-84)
NauseaGastrointestinal disorders6/22
FatigueGeneral disorders4/22
HypercalcaemiaMetabolism and nutrition disorders4/22
NasopharyngitisInfections and infestations3/22
Muscle spasmsMusculoskeletal and connective tissue disorders3/22
HeadacheNervous system disorders3/22
VomitingGastrointestinal disorders2/22
HypocalcaemiaMetabolism and nutrition disorders2/22
MyalgiaMusculoskeletal and connective tissue disorders2/22
OsteoarthritisMusculoskeletal and connective tissue disorders2/22

Baseline characteristics

The safety analysis population consisted of all participants who have received at least 1 dose of rhPTH(1-84).

Age, Continuous
Age, Continuous(years)rhPTH(1-84)
Mean50 ± 11.39
Sex: Female, Male
Sex: Female, Male(Participants)rhPTH(1-84)
Female18
Male4
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)rhPTH(1-84)
Hispanic or Latino0
Not Hispanic or Latino21
Unknown or Not Reported1
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)rhPTH(1-84)
American Indian or Alaska Native0
Asian0
Black or African American1
White20
Native Hawaiian or other Pacific Islander0
Native American And Caucasian1
08

Study locations

10 sites
  • University of Kentucky Medical Center
    Lexington, Kentucky 40536, United States
  • Crescent City Clinical Research Center, LLC
    Metairie, Louisiana 70006, United States
  • Northern Nevada Endocrinology - Lisa Abbott MD
    Reno, Nevada 89511-2060, United States
  • Ohio State University
    Columbus, Ohio 43210, United States
  • Thomas Jefferson University, Jefferson Rheumatology Associates
    Philadelphia, Pennsylvania 19107-6810, United States
  • Bone Research and Education Centre
    Oakville, Ontario L6M 1M1, Canada
  • CHU de Quebec-Universite Laval
    Québec, G1V 4G2, Canada
  • Aarhus Universitetshospital
    Aarhus N, 8200, Denmark
  • Semmelweis Egyetem
    Budapest, 1083, Hungary
  • Pecsi Tudomanyegyetem, I. sz. Belgyogyaszati Klinika
    Pécs, 7624, Hungary
09

References and documents

Publications

  • Khan AA, Abbott LG, Ahmed I, Ayodele O, Gagnon C, Finkelman RD, Mezosi E, Rejnmark L, Takacs I, Yin S, Ing SW. Open-label extension of a randomized trial investigating safety and efficacy of rhPTH(1-84) in hypoparathyroidism. JBMR Plus. 2024 Jan 5;8(3):ziad010. doi: 10.1093/jbmrpl/ziad010. eCollection 2024 Mar. PubMed 38741607 ↗

Study documents

  • Study protocol · Aug 30, 2017
  • Statistical analysis plan · Jul 29, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

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

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2018 to primary completion in Apr 2020, 18 months.

Results were first posted in Jun 2021, 1 year 2 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 20, 2017
First posted
Dec 7, 2017
StartActual
Sep 26, 2018
Primary completionActual
Apr 14, 2020
CompletionActual
Apr 14, 2020
Results first posted
Jun 16, 2021
Last update
Oct 7, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03364738
Lead sponsor
Shire
Responsible party
Sponsor
First posted
Dec 7, 2017
Start date
Sep 26, 2018
Primary completion
Apr 14, 2020
Completion
Apr 14, 2020
Results posted
Jun 16, 2021
Last update
Oct 7, 2022

Study contacts

Study Director
study director · Shire

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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