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Phase 2 Completed N=27 Randomized Treatment

Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34

Source: ClinicalTrials.gov NCT00001304 ↗
Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcomePrimary: Serum Calcium Level — 2; 1.92 mmol/liter

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.

Outcome Measures

OutcomeResultp-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

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.

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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