A Phase 2 interventional study of Synthetic Human Parathyroid Hormone 1-34 pump in Hypoparathyroidism, Hypocalcemia and Autoimmune Polyendocrine Syndrome Type 1, sponsored by National Institutes of Health Clinical Center (CC). Completed at 1 site in United States. Open to participants aged 7 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by National Institutes of Health Clinical Center (CC) · Phase 2, Interventional, and Treatment
This randomized crossover study will evaluate the safety, efficacy, and pharmacodynamics of synthetic human PTH 1-34 (PTH) delivered by an insulin pump (omnipod) compared with twice- daily subcutaneous injections. We predict pump delivery of PTH will simultaneously normalize blood and urine mineral levels with minimal or no fluctuations throughout the day, thus resulting in a more physiologic pharmacodynamic profile because this method of delivery mimics normal parathyroid gland function. Furthermore, we hypothesize that pump therapy will require lower PTH doses and will normalize markers of bone turnover. We anticipate the improved metabolic control when PTH is delivered by pump will be evident both in adults with surgically induced hypoparathyroidism and in children with more severe forms of hypoparathyroidism where there is an unmet need for improved therapy.
Prior studies (92-CH-0011) have been important in establishing synthetic human parathyroid hormone 1-34 (PTH) as a beneficial treatment for hypoparathyroidism, superior to conventional therapy with calcitriol and calcium. We are conducting a randomized crossover study comparing PTH delivered by an insulin pump vs twice-daily subcutaneous injections. We hypothesize that pump delivery of PTH 1-34, compared to injections, will provide smoother metabolic control of serum mineral levels with minimal fluctuations, normalization of urine mineral excretion and markers of bone turnover. The two arms will be divided into an inpatient and an outpatient phase. There will be three inpatient admissions at baseline, 3 months and 6 months which are separated by two 3-month outpatient periods.
Patients between 10 and 70 years of age with chronic hypoparathyroidism for at least 1 year may be eligible for participation in this study. After the baseline evaluation, conventional therapy (calcitriol and calcium supplements) is discontinued and PTH delivered by an insulin pump (Omnipod) or by twice-daily subcutaneous injections is initiated, depending on randomization sequence. PTH is provided for the study (Clinical Center Pharmacy) in 200 mcg/mL vials. The initial PTH daily dose is 0.2 μg/kg/day for pump therapy and 0.5 μg/kg/day for the twice-daily injection therapy. Inpatient admissions consist of daily (early morning) blood collections for mineral levels, 1,25 OH vitamin D, and markers of bone turnover along with 24-h urine excretion measures of minerals to determine the optimal individualized dose. Titration of PTH dose continues during the outpatient phase with blood labs measured on a weekly basis and less often, when frequent changes are considered unnecessary. Study participants will cross over to the alternate PTH delivery method (PTH delivered by pump vs. injections) at the conclusion of the initial 3-month treatment period. At the conclusion of the third hospital admission, patients will return to the therapy they were receiving at study entry.
128 studies on the registry are indexed under Hypoparathyroidism; 30 are open to participants now.
This study's enrollment of 21 is below the median of 50 across 77 interventional studies indexed under Hypoparathyroidism.
Browse Hypoparathyroidism studies →National Institutes of Health Clinical Center (CC) is the lead sponsor of 375 studies on the registry; 27 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 19 (83%) have results posted.
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This study will include up to 24 patients of both genders (ages 7-70) with biochemically confirmed chronic hypoparathyroidism of at least one year duration. We will recruit adults with post-surgical hypoparathyroidism and children with genetic forms of hypoparathyroidism including polyendocrine syndrome type 1 (APS-1) or hypocalcemia due to an activating mutation of the calcium sensing receptor.
EXCLUSION CRITERIA:
Subjects who meet any of the following criteria are not eligible for study entry:
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.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, received Synthetic Human Parathyroid Hormone 1-34 (PTH) delivered through an insulin pump. The first admission included measures of blood and urine minerals for dose titration. The initial PTH dose was 0.2 μg/kg/day. After inpatient and outpatient blood and urine monitoring, the final mean dose at 13 weeks was 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults. At the conclusion of the initial three-month study period, patients crossed over to the opposite arm (PTH by pump vs injections) for the final 3 months with the identical monitoring protocol.
Drug: Synthetic Human Parathyroid Hormone 1-34 pump
Children with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism receive synthetic human parathyroid hormone 1-34 (PTH) delivered by twice-daily subcutaneous injections. The initial PTH total daily dose of 0.5 μg/kg/day. After inpatient and outpatient blood and urine monitoring, the final mean dose at 13 weeks was 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults. At the conclusion of the first three-month study period, patients crossed over to the opposite drug-delivery arm (PTH delivered by pump vs injections) and entered the second 3-month study period, with the identical monitoring protocol.
Drug: Synthetic Human Parathyroid Hormone 1-34 pump
comparing two delivery modalities for PTH: insulin pump versus subcutaneous injections.
Mean Serum Calcium in Children and Young Adults
Mean fasting serum calcium level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Time frame: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection
Mean Serum Calcium in Adults
Mean fasting serum calcium level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Time frame: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection
Mean Urine Calcium Excretion in Children and Young Adults
Mean 24-hour urine calcium excretion at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated with values corrected for body surface area in children and young adults.
Time frame: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection
Mean Urine Calcium Excretion in Adults
Mean 24-hour urine calcium excretion at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated.
Time frame: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection
Mean Serum Phosphorus in Children and Young Adults
Mean fasting serum phosphorus level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Time frame: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection
Mean Serum Phosphorus in Adults
Mean fasting serum phosphorus level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Time frame: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection
Mean Urine Phosphorus Excretion in Children and Young Adults
Mean 24-hour urine phosphorus excretion at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated with values corrected for body surface area in children and young adults.
Time frame: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection
Mean Urine Phosphorus Excretion in Adults
Mean 24-hour urine phosphorus excretion at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated.
Time frame: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection
Mean Serum Magnesium in Children and Young Adults
Mean fasting serum magnesium level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Time frame: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection
Mean Serum Magnesium in Adults
Mean fasting serum magnesium level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Time frame: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection
Mean Urine Magnesium Excretion in Children and Young Adults
Mean 24-hour urine magnesium excretion at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated with values corrected for body surface area in children and young adults.
Time frame: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection
Mean Urine Magnesium Excretion in Adults
Mean 24-hour urine magnesium excretion at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated.
Time frame: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection
Mean Serum Alkaline Phosphatase in Children and Young Adults
Mean fasting serum alkaline phosphatase level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Time frame: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection
Mean Serum Alkaline Phosphatase in Adults
Mean fasting serum alkaline phosphatase level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Time frame: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection
Mean Serum Bone-specific Alkaline Phosphatase in Children and Young Adults
Mean fasting serum bone-specific alkaline phosphatase level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Time frame: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection
Mean Serum 1,25-hydroxyvitamin D3 in Children and Young Adults
Mean fasting serum 1,25-hydroxyvitamin D3 level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Time frame: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection
Mean Serum 1,25-hydroxyvitamin D3 in Adults
Mean fasting serum 1,25-hydroxyvitamin D3 level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Time frame: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection
Mean Serum 25-hydroxyvitamin D3 in Children and Young Adults
Mean fasting serum 25-hydroxyvitamin D3 level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Time frame: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection
Mean Serum 25-hydroxyvitamin D3 in Adults
Mean fasting serum 25-hydroxyvitamin D3 level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Time frame: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection
Mean Urine Creatinine Clearance Excretion in Children and Young Adults
Mean 24-hour urine creatinine clearance excretion at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated with values corrected for body surface area in children and young adults.
Time frame: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection
Mean Urine Creatinine Clearance Excretion in Adults
Mean 24-hour urine creatinine clearance excretion at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated.
Time frame: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection
Mean Serum Osteocalcin in Children and Young Adults
Mean fasting serum osteocalcin level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Time frame: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection
Mean Serum Osteocalcin in Adults
Mean fasting serum osteocalcin level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Time frame: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection
Mean Urine N-terminal Telopeptide Level in Children and Young Adults
Mean 24-hour urine N-terminal telopeptide of type 1 collagen excretion at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated with values corrected for body surface area in children and young adults.
Time frame: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection
Mean Urine N-terminal Telopeptide Level in Adults
Mean 24-hour urine N-terminal telopeptide of type 1 collagen excretion at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated.
Time frame: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection
Mean Blood Mineral Levels - Calcium, Phosphorus, Magnesium
Mean fasting serum calcium, phosphorus, and magnesium levels first three days of initial baseline inpatient admission. Participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Time frame: Day 1-3 of baseline initial inpatient evaluation
Mean Urine Mineral Excretion - Calcium, Phosphorus, Magnesium
Mean 24-hour urine calcium, phosphorus, and magnesium excretion first 3 days of initial baseline inpatient admission. Participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated with values corrected for body surface area in children and young adults.
Time frame: Day 1-3 of baseline initial inpatient evaluation
Mean Serum Alkaline Phosphatase
Mean fasting serum alkaline phosphatase level first 3 days of initial baseline inpatient admission. Participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Time frame: Day 1-3 of baseline initial inpatient evaluation
Mean Serum Bone Specific Alkaline Phosphatase in Children and Young Adults
Mean fasting serum bone specific alkaline phosphatase level first 3 days of initial baseline inpatient admission. Participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Time frame: Day 1-3 of baseline initial inpatient evaluation
Mean Serum 1,25-hydroxyvitamin D3
Mean fasting serum 1,25-hydroxyvitamin D3 level first 3 days of initial baseline inpatient admission. Participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Time frame: Day 1-3 of baseline initial inpatient evaluation
Mean Serum Bone Minerals - 25-hydroxyvitamin D3 and Osteocalcin
Mean fasting serum 25-hydroxyvitamin D3 and osteocalcin levels first 3 days of initial baseline inpatient admission. Participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Time frame: Day 1-3 of baseline initial inpatient evaluation
Mean Urine Creatinine Clearance Excretion
Mean 24-hour urine creatinine clearance excretion first 3 days of initial baseline inpatient admission. Participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated with values corrected for body surface area in children.
Time frame: Day 1-3 of baseline initial inpatient evaluation
Mean Urine N-terminal Telopeptide Level
Mean 24-hour urine N-terminal telopeptide of type 1 collagen excretion first 3 days of initial baseline inpatient admission. Participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated with values corrected for body surface area in children.
Time frame: Day 1-3 of baseline initial inpatient evaluation
| Milestone | PTH 1-34 Delivered Through Pump, Then Subcutaneous Injection | PTH 1-34 Subcutaneous Injection, Then Delivered Through Pump |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
| Milestone | PTH 1-34 Delivered Through Pump, Then Subcutaneous Injection | PTH 1-34 Subcutaneous Injection, Then Delivered Through Pump |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
Mean fasting serum calcium level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
| mmol/liter | PTH 1-34 Delivered Through Pump | PTH 1-34 Subcutaneous Injection |
|---|---|---|
| Mean Serum Calcium in Children and Young Adults | 2.02 ± 0.053 | 1.88 ± 0.03 |
Mean fasting serum calcium level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
| mmol/liter | PTH 1-34 Delivered Through Pump | PTH 1-34 Subcutaneous Injection |
|---|---|---|
| Mean Serum Calcium in Adults | 2.078 ± 0.065 | 2.153 ± 0.042 |
Mean 24-hour urine calcium excretion at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated with values corrected for body surface area in children and young adults.
| mmol/24h | PTH 1-34 Delivered Through Pump | PTH 1-34 Subcutaneous Injection |
|---|---|---|
| Mean Urine Calcium Excretion in Children and Young Adults | 5.17 ± 1.10 | 6.67 ± 0.76 |
Mean 24-hour urine calcium excretion at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated.
| mmol/24h | PTH 1-34 Delivered Through Pump | PTH 1-34 Subcutaneous Injection |
|---|---|---|
| Mean Urine Calcium Excretion in Adults | 3.981 ± 0.679 | 9.655 ± 1.045 |
Mean fasting serum phosphorus level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
| mmol/liter | PTH 1-34 Delivered Through Pump | PTH 1-34 Subcutaneous Injection |
|---|---|---|
| Mean Serum Phosphorus in Children and Young Adults | 1.78 ± 0.07 | 1.58 ± 0.07 |
Mean fasting serum phosphorus level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
| mmol/liter | PTH 1-34 Delivered Through Pump | PTH 1-34 Subcutaneous Injection |
|---|---|---|
| Mean Serum Phosphorus in Adults | 1.401 ± 0.086 | 1.350 ± 0.050 |
Mean 24-hour urine phosphorus excretion at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated with values corrected for body surface area in children and young adults.
| mmol/24h | PTH 1-34 Delivered Through Pump | PTH 1-34 Subcutaneous Injection |
|---|---|---|
| Mean Urine Phosphorus Excretion in Children and Young Adults | 1.10 ± 0.25 | 0.83 ± 0.10 |
Mean 24-hour urine phosphorus excretion at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated.
| mmol/24h | PTH 1-34 Delivered Through Pump | PTH 1-34 Subcutaneous Injection |
|---|---|---|
| Mean Urine Phosphorus Excretion in Adults | 28.697 ± 3.023 | 31.792 ± 3.723 |
Mean fasting serum magnesium level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
| mmol/liter | PTH 1-34 Delivered Through Pump | PTH 1-34 Subcutaneous Injection |
|---|---|---|
| Mean Serum Magnesium in Children and Young Adults | 0.74 ± 0.02 | 0.65 ± 0.02 |
Mean fasting serum magnesium level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
| mmol/liter | PTH 1-34 Delivered Through Pump | PTH 1-34 Subcutaneous Injection |
|---|---|---|
| Mean Serum Magnesium in Adults | 0.855 ± 0.020 | 0.778 ± 0.017 |
Mean 24-hour urine magnesium excretion at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated with values corrected for body surface area in children and young adults.
| mmol/24h | PTH 1-34 Delivered Through Pump | PTH 1-34 Subcutaneous Injection |
|---|---|---|
| Mean Urine Magnesium Excretion in Children and Young Adults | 6.06 ± 1.28 | 7.38 ± 1.33 |
Mean 24-hour urine magnesium excretion at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated.
| mmol/24h | PTH 1-34 Delivered Through Pump | PTH 1-34 Subcutaneous Injection |
|---|---|---|
| Mean Urine Magnesium Excretion in Adults | 4.007 ± 0.363 | 4.766 ± 0.748 |
Mean fasting serum alkaline phosphatase level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
| U/liter | PTH 1-34 Delivered Through Pump, Then Subcutaneous Injection | PTH 1-34 Subcutaneous Injection, Then Delivered Through Pump |
|---|---|---|
| Mean Serum Alkaline Phosphatase in Children and Young Adults | 147.93 ± 19.58 | 242.31 ± 44.54 |
Mean fasting serum alkaline phosphatase level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
| U/liter | PTH 1-34 Delivered Through Pump, Then Subcutaneous Injection | PTH 1-34 Subcutaneous Injection, Then Delivered Through Pump |
|---|---|---|
| Mean Serum Alkaline Phosphatase in Adults | 92.531 ± 12.242 | 109.191 ± 15.105 |
Mean fasting serum bone-specific alkaline phosphatase level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
| MCG/L | PTH 1-34 Delivered Through Pump | PTH 1-34 Subcutaneous Injection |
|---|---|---|
| Mean Serum Bone-specific Alkaline Phosphatase in Children and Young Adults | 51.68 ± 8.90 | 81.64 ± 16.56 |
Mean fasting serum 1,25-hydroxyvitamin D3 level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
| pg/ml | PTH 1-34 Delivered Through Pump | PTH 1-34 Subcutaneous Injection |
|---|---|---|
| Mean Serum 1,25-hydroxyvitamin D3 in Children and Young Adults | 75.21 ± 7.78 | 55.63 ± 5.07 |
Mean fasting serum 1,25-hydroxyvitamin D3 level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
| pg/ml | PTH 1-34 Delivered Through Pump | PTH 1-34 Subcutaneous Injection |
|---|---|---|
| Mean Serum 1,25-hydroxyvitamin D3 in Adults | 32 ± 3.257 | 35.286 ± 3.239 |
Mean fasting serum 25-hydroxyvitamin D3 level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
| ng/ml | PTH 1-34 Delivered Through Pump | PTH 1-34 Subcutaneous Injection |
|---|---|---|
| Mean Serum 25-hydroxyvitamin D3 in Children and Young Adults | 37.96 ± 3.23 | 32.92 ± 3.46 |
Mean fasting serum 25-hydroxyvitamin D3 level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
| ng/ml | PTH 1-34 Delivered Through Pump | PTH 1-34 Subcutaneous Injection |
|---|---|---|
| Mean Serum 25-hydroxyvitamin D3 in Adults | 34.5 ± 2.909 | 32.143 ± 3.612 |
Mean 24-hour urine creatinine clearance excretion at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated with values corrected for body surface area in children and young adults.
| ml/min | PTH 1-34 Delivered Through Pump | PTH 1-34 Subcutaneous Injection |
|---|---|---|
| Mean Urine Creatinine Clearance Excretion in Children and Young Adults | 111.57 ± 13.91 | 106.63 ± 6.74 |
Mean 24-hour urine creatinine clearance excretion at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated.
| ml/min | PTH 1-34 Delivered Through Pump | PTH 1-34 Subcutaneous Injection |
|---|---|---|
| Mean Urine Creatinine Clearance Excretion in Adults | 106.938 ± 9.235 | 114.021 ± 10.736 |
Mean fasting serum osteocalcin level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
| ng/mL | PTH 1-34 Delivered Through Pump | PTH 1-34 Subcutaneous Injection |
|---|---|---|
| Mean Serum Osteocalcin in Children and Young Adults | 188.75 ± 20.72 | 308.16 ± 43.27 |
Mean fasting serum osteocalcin level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
| ng/mL | PTH 1-34 Delivered Through Pump | PTH 1-34 Subcutaneous Injection |
|---|---|---|
| Mean Serum Osteocalcin in Adults | 40.963 ± 9.714 | 73.408 ± 16.401 |
Mean 24-hour urine N-terminal telopeptide of type 1 collagen excretion at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated with values corrected for body surface area in children and young adults.
| nmol/mmol | PTH 1-34 Delivered Through Pump | PTH 1-34 Subcutaneous Injection |
|---|---|---|
| Mean Urine N-terminal Telopeptide Level in Children and Young Adults | 404.79 ± 87.00 | 1116.75 ± 323.91 |
Mean 24-hour urine N-terminal telopeptide of type 1 collagen excretion at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated.
| nmol/mmol | PTH 1-34 Delivered Through Pump | PTH 1-34 Subcutaneous Injection |
|---|---|---|
| Mean Urine N-terminal Telopeptide Level in Adults | 46.625 ± 8.729 | 116.063 ± 26.567 |
Mean fasting serum calcium, phosphorus, and magnesium levels first three days of initial baseline inpatient admission. Participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
| mmol/liter | Baseline Evaluation |
|---|---|
| Serum Calcium (Children and young adults) | 1.967 ± 0.038 |
| Serum Calcium (Adults) | 2.144 ± 0.059 |
| Serum Phosphorus (Children and young adults) | 1.662 ± 0.096 |
| Serum Phosphorus (Adults) | 1.475 ± 0.042 |
| Serum Magnesium (Children and young adults) | 0.700 ± 0.019 |
| Serum Magnesium (Adults) | 0.842 ± 0.034 |
Mean 24-hour urine calcium, phosphorus, and magnesium excretion first 3 days of initial baseline inpatient admission. Participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated with values corrected for body surface area in children and young adults.
| mmol/24h | Baseline Evaluation |
|---|---|
| Urine calcium excretion (Children and young adults) | 7.176 ± 0.649 |
| Urine calcium excretion (Adults) | 9.371 ± 1.323 |
| Urine phosphorus excretion (Children and young adults) | 0.747 ± 0.070 |
| Urine phosphorus excretion (Adults) | 26.41 ± 3.982 |
| Urine magnesium excretion (Children and young adults) | 6.975 ± 1.212 |
| Urine magnesium excretion (Adults) | 5.665 ± 0.386 |
Mean fasting serum alkaline phosphatase level first 3 days of initial baseline inpatient admission. Participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
| U/liter | Baseline Evaluation |
|---|---|
| Children and young adults | 180.736 ± 28.050 |
| Adults | 60.729 ± 4.499 |
Mean fasting serum bone specific alkaline phosphatase level first 3 days of initial baseline inpatient admission. Participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
| MCG/L | Baseline Evaluation |
|---|---|
| Mean Serum Bone Specific Alkaline Phosphatase in Children and Young Adults | 66.838 ± 13.594 |
Mean fasting serum 1,25-hydroxyvitamin D3 level first 3 days of initial baseline inpatient admission. Participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
| pg/ml | Baseline Evaluation |
|---|---|
| Children and young adults | 56.083 ± 6.605 |
| Adults | 33.063 ± 4.524 |
Mean fasting serum 25-hydroxyvitamin D3 and osteocalcin levels first 3 days of initial baseline inpatient admission. Participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
| ng/ml | Baseline Evaluation |
|---|---|
| 25-hydroxyvitamin D3 (Children and young adults) | 40.5 ± 4.391 |
| 25-hydroxyvitamin D3 (Adults) | 33.436 ± 4.669 |
| Osteocalcin (Children and young adults) | 274.356 ± 50.009 |
| Osteocalcin (Adults) | 15.992 ± 4.0746 |
Mean 24-hour urine creatinine clearance excretion first 3 days of initial baseline inpatient admission. Participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated with values corrected for body surface area in children.
| ml/min | Baseline Evaluation |
|---|---|
| Children and young adults | 99.100 ± 10.760 |
| Adults | 109.625 ± 9.956 |
Mean 24-hour urine N-terminal telopeptide of type 1 collagen excretion first 3 days of initial baseline inpatient admission. Participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated with values corrected for body surface area in children.
| NMOL/MMOL | Baseline Evaluation |
|---|---|
| Children and young adults | 520.830 ± 109.473 |
| Adults | 16.976 ± 3.006 |
Collected over 28 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PTH 1-34 Delivered Through Pump | 0/20 (0%) | 0/20 (0%) | 3/20 (15%) |
| PTH 1-34 Subcutaneous Injection | 0/20 (0%) | 0/20 (0%) | 4/20 (20%) |
| Event | PTH 1-34 Delivered Through Pump | PTH 1-34 Subcutaneous Injection |
|---|---|---|
| Unintentional medical device removalInjury, poisoning and procedural complications | 3/20 | 0/20 |
| Injection site erythemaGeneral disorders | 0/20 | 2/20 |
| Catheter site extravasationGeneral disorders | 0/20 | 1/20 |
| FatigueGeneral disorders | 0/20 | 1/20 |
| HyperthermiaGeneral disorders | 0/20 | 1/20 |
| Pneumonia viralInfections and infestations | 0/20 | 1/20 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/20 | 1/20 |
| HospitalisationSurgical and medical procedures | 0/20 | 1/20 |
| Age, Customized(Participants) | Overall Study Participants |
|---|---|
| 7-20 years | 12 |
| >= 21 years | 8 |
| Sex: Female, Male(Participants) | Overall Study Participants |
|---|---|
| Female | 14 |
| Male | 6 |
| Ethnicity (NIH/OMB)(Participants) | Overall Study Participants |
|---|---|
| Hispanic or Latino | 4 |
| Not Hispanic or Latino | 16 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Overall Study Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 16 |
| More than one race | 2 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Overall Study Participants |
|---|---|
| United States | 20 |
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