Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34

United States Department of Health and Human Services (HHS)

Status and phase: Completed; Phase 2

Conditions: Hypoparathyroidism

Treatments: Drug: Synthetic Human Parathyroid Hormone 1-34; Drug: Calcitriol & Calcium

Study type: Interventional

Funder types: NIH

Identifiers

NCT00001304

92-CH-0011 (Other Grant/Funding Number)

920011

Details and patient eligibility

About

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.

Full description

Vitamin D and its analogs, the conventional treatment for hypoparathyroidism, are associated with chronic hypercalciuria due to their lack of calcium-retaining effect in the kidney. This side effect usually occurs even while maintaining the serum calcium in the normal range and may lead to calcium deposition in the kidney (nephrocalcinosis) and renal insufficiency. This study examines the long-term effects of subcutaneous parathyroid hormone (PTH) therapy on calcium metabolism, bone, and renal function. Our previous short-term pilot study comparing subcutaneous PTH with calcitriol demonstrated a significant decrease in urinary calcium excretion during PTH therapy. Based upon these results, we hypothesized that treatment with PTH is more physiologic and provides improved long-term metabolic control. Additionally, treatment with PTH may avoid the adverse side effects on the kidney that are associated with conventional therapy. Patients initially come to the Clinical Center for a two week inpatient evaluation. Subsequent follow-up will occur semiannually on an outpatient basis.

Enrollment: 27 patients

Sex: All

Ages: 17 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• INCLUSION CRITERIA:

This study will include patients (ages 17-69) with biochemically confirmed hypoparathyroidism.

EXCLUSION CRITERIA

Women who are pregnant will be excluded.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

PTH 1-34

Experimental group

Description:

All patients received twice daily synthetic Human Parathyroid Hormone 1-34.

Treatment:

Drug: Synthetic Human Parathyroid Hormone 1-34

Calcitriol & Calcium

Experimental group

Description:

All patients received twice daily Calcitriol and Calcium 1000mg divided into four doses daily.

Treatment:

Drug: Calcitriol & Calcium