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Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34

NCT ID: NCT00001304

Last Updated: 2015-12-15

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

1991-10-31

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypoparathyroidism

Keywords

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Hypoparathyroidism Parathyroid Hormone Vitamin D Calcium Metabolism PTH 1-34 Bone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PTH 1-34

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

Group Type EXPERIMENTAL

Synthetic Human Parathyroid Hormone 1-34

Intervention Type DRUG

twice daily subcutaneous injections

Calcitriol & Calcium

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

Group Type EXPERIMENTAL

Calcitriol & Calcium

Intervention Type DRUG

Twice daily oral calcitriol with 1000 mg Calcium carbonate supplementation

Interventions

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Synthetic Human Parathyroid Hormone 1-34

twice daily subcutaneous injections

Intervention Type DRUG

Calcitriol & Calcium

Twice daily oral calcitriol with 1000 mg Calcium carbonate supplementation

Intervention Type DRUG

Other Intervention Names

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teriperitide rocaltrol; 1,25 OH Vitamin D

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

Women who are pregnant will be excluded.
Minimum Eligible Age

17 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role lead

Responsible Party

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Karen K. Winer, M.D.

medical officer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen K Winer, M.D.

Role: PRINCIPAL_INVESTIGATOR

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Locations

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National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 8773636 (View on PubMed)

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. doi: 10.1210/jcem.83.10.5185.

Reference Type BACKGROUND
PMID: 9768650 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22090268 (View on PubMed)

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. doi: 10.1210/jc.2002-021736.

Reference Type BACKGROUND
PMID: 12970289 (View on PubMed)

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. doi: 10.1210/jc.2007-2552. Epub 2008 May 20.

Reference Type BACKGROUND
PMID: 18492754 (View on PubMed)

Other Identifiers

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92-CH-0011

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

920011

Identifier Type: -

Identifier Source: org_study_id