Phase 2
N=27
Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34
Hypoparathyroidism
Bottom Line
View on ClinicalTrials.gov: NCT00001304 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcome: Primary: Serum Calcium Level — 2; 1.92 mmol/liter
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Synthetic Human Parathyroid Hormone 1-34 (Drug); Calcitriol & Calcium (Drug)
- Age
- Pediatric, Adult, Older Adult · 17+ yrs
- Sex
- All
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Calcium Level |
2; 1.92 | — |
| PRIMARY Urine Calcium Excretion Level |
8.2; 5.8 | — |
| SECONDARY Serum 1,25-hydroxyvitamin D Level |
40; 43 | — |
| SECONDARY Serum 25-hydroxyvitamin D Level |
31; 28 | — |
| SECONDARY Serum Magnesium Level |
0.75; 0.73 | — |
| SECONDARY Serum Phosphorus Level |
4.5; 4.6 | — |
| SECONDARY Urinary Creatinine Clearance |
84; 80 | — |
Summary
This study has been important in establishing synthetic human parathyroid hormone 1-34 (PTH) as a beneficial treatment for hypoparathyroidism, superior to conventional therapy with calcium and calcitriol. Providing synthetic human parathyroid hormone 1-34 (PTH) to patients who are unresponsive to conventional therapy has enabled severe cases of hypoparathyroidism to be managed effectively with the investigational drug, PTH. The primary goals of this study are to (1) provide long-term PTH therapy to patients who do not respond to conventional therapy; (2) understand the long-term effect of therapeutic PTH replacement on kidney function and bone mineral density; (3) study and track linear growth and bone accrual in children with hypoparathyroidism. (4) determine if subjects reach a normal level of peak bone mass and if the timing of this is comparable to normal age-matched healthy controls.
Eligibility Criteria
- INCLUSION CRITERIA:
This study will include patients (ages 17-69) with biochemically confirmed hypoparathyroidism.
EXCLUSION CRITERIA
Women who are pregnant will be excluded.
Data sourced from ClinicalTrials.gov (NCT00001304). 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.