Phase 2
N=20
Comparing Pump With Subcutaneous Injection Delivery of PTH 1-34 in the Management of Chronic Hypoparathyroidism
Hypoparathyroidism · Hypocalcemia · Autoimmune Polyendocrine Syndrome Type 1 · Autosomal Dominant Hypocalcemia Type 1 (ADH1)
Bottom Line
View on ClinicalTrials.gov: NCT00743782 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Mean Serum Calcium in Children and Young Adults — 2.02; 1.88 mmol/liter — p=0.02
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Synthetic Human Parathyroid Hormone 1-34 pump (Drug)
- Age
- Pediatric, Adult, Older Adult · 7+ yrs
- Sex
- All
- Sponsor
- National Institutes of Health Clinical Center (CC)
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Serum Calcium in Children and Young Adults |
2.02; 1.88 | 0.02 sig |
| PRIMARY Mean Serum Calcium in Adults |
2.078; 2.153 | 0.41 |
| PRIMARY Mean Urine Calcium Excretion in Children and Young Adults |
5.17; 6.67 | 0.31 |
| PRIMARY Mean Urine Calcium Excretion in Adults |
3.981; 9.655 | <0.01 sig |
| SECONDARY Mean Serum Phosphorus in Children and Young Adults |
1.78; 1.58 | 0.002 sig |
| SECONDARY Mean Serum Phosphorus in Adults |
1.401; 1.350 | 0.61 |
| SECONDARY Mean Urine Phosphorus Excretion in Children and Young Adults |
1.10; 0.83 | 0.70 |
| SECONDARY Mean Urine Phosphorus Excretion in Adults |
28.697; 31.792 | 0.05 |
| SECONDARY Mean Serum Magnesium in Children and Young Adults |
0.74; 0.65 | <0.01 sig |
| SECONDARY Mean Serum Magnesium in Adults |
0.855; 0.778 | 0.02 sig |
| SECONDARY Mean Urine Magnesium Excretion in Children and Young Adults |
6.06; 7.38 | <0.01 sig |
| SECONDARY Mean Urine Magnesium Excretion in Adults |
4.007; 4.766 | 0.25 |
| SECONDARY Mean Serum Alkaline Phosphatase in Children and Young Adults |
147.93; 242.31 | <0.01 sig |
| SECONDARY Mean Serum Alkaline Phosphatase in Adults |
92.531; 109.191 | 0.16 |
| SECONDARY Mean Serum Bone-specific Alkaline Phosphatase in Children and Young Adults |
51.68; 81.64 | 0.01 sig |
| SECONDARY Mean Serum 1,25-hydroxyvitamin D3 in Children and Young Adults |
75.21; 55.63 | 0.01 sig |
| SECONDARY Mean Serum 1,25-hydroxyvitamin D3 in Adults |
32; 35.286 | 0.53 |
| SECONDARY Mean Serum 25-hydroxyvitamin D3 in Children and Young Adults |
37.96; 32.92 | 0.09 |
| SECONDARY Mean Serum 25-hydroxyvitamin D3 in Adults |
34.5; 32.143 | 0.27 |
| SECONDARY Mean Urine Creatinine Clearance Excretion in Children and Young Adults |
111.57; 106.63 | 0.01 sig |
| SECONDARY Mean Urine Creatinine Clearance Excretion in Adults |
106.938; 114.021 | 0.40 |
| SECONDARY Mean Serum Osteocalcin in Children and Young Adults |
188.75; 308.16 | 0.01 sig |
| SECONDARY Mean Serum Osteocalcin in Adults |
40.963; 73.408 | 0.14 |
| SECONDARY Mean Urine N-terminal Telopeptide Level in Children and Young Adults |
404.79; 1116.75 | 0.02 sig |
| SECONDARY Mean Urine N-terminal Telopeptide Level in Adults |
46.625; 116.063 | 0.04 sig |
| SECONDARY Mean Blood Mineral Levels - Calcium, Phosphorus, Magnesium |
1.967; 2.144; 1.662; 1.475; 0.700; 0.842 | — |
| SECONDARY Mean Urine Mineral Excretion - Calcium, Phosphorus, Magnesium |
7.176; 9.371; 0.747; 26.41; 6.975; 5.665 | — |
| SECONDARY Mean Serum Alkaline Phosphatase |
180.736; 60.729 | — |
| SECONDARY Mean Serum Bone Specific Alkaline Phosphatase in Children and Young Adults |
66.838 | — |
| SECONDARY Mean Serum 1,25-hydroxyvitamin D3 |
56.083; 33.063 | — |
| SECONDARY Mean Serum Bone Minerals - 25-hydroxyvitamin D3 and Osteocalcin |
40.5; 33.436; 274.356; 15.992 | — |
| SECONDARY Mean Urine Creatinine Clearance Excretion |
99.100; 109.625 | — |
| SECONDARY Mean Urine N-terminal Telopeptide Level |
520.830; 16.976 | — |
Summary
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.
Eligibility Criteria
- INCLUSION CRITERIA:
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 autoimmune 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:
- Presence of significant hepatic or kidney disease
- Pregnancy
- Patients who are calcium infusion dependent.
- Seizure disorder requiring antiepileptic medications
Data sourced from ClinicalTrials.gov (NCT00743782). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.