Expired Study
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Bethesda, Maryland 20892


Purpose:

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 summary:

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.


Criteria:

- INCLUSION CRITERIA: This study will include patients (ages 4-70) with biochemically confirmed hypoparathyroidism. EXCLUSION CRITERIA Women who are pregnant will be excluded.


Study is Available At:


Original ID:

920011


NCT ID:

NCT00001304


Secondary ID:

92-CH-0011


Study Acronym:


Brief Title:

Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34


Official Title:

Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

4 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institutes of Health Clinical Center (CC)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

85


Enrollment Type:

Actual


Overall Contact Information

Official Name:Karen K Winer, M.D.
Principal Investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Dates

Start Date:October 1991
Completion Date:April 2014
Completion Type:Actual
Primary Completion Date:March 2014
Primary Completion Type:Actual
Verification Date:April 2014
Last Changed Date:November 20, 2014
First Received Date:November 3, 1999

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Bone mineral density, makers of bone turnover, renal function, serum and urine magnesium and phosphorus, linear growth parameters.
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Serum and urine calcium.
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:PTH 1-34
Description:N/A

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Winer KK, Sinaii N, Peterson D, Sainz B Jr, Cutler GB Jr. Effects of once versus twice-daily parathyroid hormone 1-34 therapy in children with hypoparathyroidism. J Clin Endocrinol Metab. 2008 Sep;93(9):3389-95. Epub 2008 May 20.
PMID:18492754
Reference Type:Reference
Citation:Winer KK, Ko CW, Reynolds JC, Dowdy K, Keil M, Peterson D, Gerber LH, McGarvey C, Cutler GB Jr. Long-term treatment of hypoparathyroidism: a randomized controlled study comparing parathyroid hormone-(1-34) versus calcitriol and calcium. J Clin Endocrinol Metab. 2003 Sep;88(9):4214-20.
PMID:12970289
Reference Type:Reference
Citation:Winer KK, Zhang B, Shrader JA, Peterson D, Smith M, Albert PS, Cutler GB Jr. Synthetic human parathyroid hormone 1-34 replacement therapy: a randomized crossover trial comparing pump versus injections in the treatment of chronic hypoparathyroidism. J Clin Endocrinol Metab. 2012 Feb;97(2):391-9. doi: 10.1210/jc.2011-1908. Epub 2011 Nov 16.
PMID:22090268
Reference Type:Reference
Citation:Winer KK, Yanovski JA, Sarani B, Cutler GB Jr. A randomized, cross-over trial of once-daily versus twice-daily parathyroid hormone 1-34 in treatment of hypoparathyroidism. J Clin Endocrinol Metab. 1998 Oct;83(10):3480-6.
PMID:9768650
Reference Type:Reference
Citation:Winer KK, Yanovski JA, Cutler GB Jr. Synthetic human parathyroid hormone 1-34 vs calcitriol and calcium in the treatment of hypoparathyroidism. JAMA. 1996 Aug 28;276(8):631-6.
PMID:8773636

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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