Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34|
- Serum and urine calcium. [ Designated as safety issue: No ]
- Bone mineral density, makers of bone turnover, renal function, serum and urine magnesium and phosphorus, linear growth parameters. [ Designated as safety issue: No ]
|Study Start Date:||October 1991|
|Estimated Study Completion Date:||April 2015|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Drug: PTH 1-34
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001304
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Karen K Winer, M.D.||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|