Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )
ClinicalTrials.gov Identifier:
NCT00001304
First received: November 3, 1999
Last updated: April 8, 2014
Last verified: April 2014

November 3, 1999
April 8, 2014
October 1991
March 2014   (final data collection date for primary outcome measure)
Serum and urine calcium. [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00001304 on ClinicalTrials.gov Archive Site
Bone mineral density, makers of bone turnover, renal function, serum and urine magnesium and phosphorus, linear growth parameters. [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34
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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Hypoparathyroidism
Drug: PTH 1-34
N/A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
85
April 2015
March 2014   (final data collection date for primary outcome measure)
  • INCLUSION CRITERIA:

This study will include patients (ages 4-70) with biochemically confirmed hypoparathyroidism.

EXCLUSION CRITERIA

Women who are pregnant will be excluded.

Both
4 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00001304
920011, 92-CH-0011
Not Provided
National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
Principal Investigator: Karen K Winer, M.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health Clinical Center (CC)
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP