Protocol Number: 92-CH-0011

Title:

Treatment of Hypoparathyroidism with Synthetic Human Parathyroid Hormone 1-34

Number:

92-CH-0011

Summary:

The conventional treatment for hypoparathyroidism, is associated with chronic increased levels of calcium in the urine (hypercalciuria) due to the kidney's inability to retain calcium. This side effect usually occurs even while maintaining the level of calcium in the blood at a normal range. As a result the kidneys may become damaged due to calcium deposits (nephrocalcinosis) and work ineffectively (renal insufficiency).

This study will compare the long term effects of twice-daily injections of parathyroid hormone (PTH) with twice-daily doses of oral calcitriol in patients with hypoparathyroidism.

Researchers believe, based on previous studies, that injections of PTH will provide better control of hypoparathyroidism. In addition, PTH appears to avoid the side effects typically associated with conventional therapy for hypoparathyroidism.

Sponsoring Institute:

National Institute of Child Health and Human Development (NICHD)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

This study will include patients (ages 4-70) with biochemically confirmed hypoparathyroidism of at least one year duration.

Patients with rare forms of congenital hypoparatyroidism such as DiGeorge Syndrome will be included in the study.

EXCLUSION CRITERIA

Women who are pregnant will be excluded.

Patients who have significant hepatic or kidney disease (GFR less than 25 mL/min) will be excluded since renal failure would interfere with our measurements of the PTH effect on the kidney.

Special Instructions:

Currently Not Provided

Keywords:

Hypoparathyroidism

Parathyroid Hormone

Vitamin D

Calcium Metabolism

Cyclic AMP

Recruitment Keyword(s):

None

Condition(s):

Hypoparathyroidism

Investigational Drug(s):

PTH 1-34

Investigational Device(s):

None

Intervention(s):

Drug: PTH 1-34

Supporting Site:

National Institute of Child Health and Human Development

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

A randomized, cross-over trial of once-daily versus twice-daily parathyroid hormone 1-34 in treatment of hypoparathyroidism. Winer KK, Yanovski JA, Sarani B, Cutler GB Jr. J Clin Endocrinol Metab. 1998 Oct;83(10):3480-6.

Effects of once versus twice-daily parathyroid hormone 1-34 therapy in children with hypoparathyroidism. Winer KK, Sinaii N, Peterson D, Sainz B Jr, Cutler GB Jr. J Clin Endocrinol Metab. 2008 Sep;93(9):3389-95. Epub 2008 May 20.

Long-term treatment of hypoparathyroidism: a randomized controlled study comparing parathyroid hormone-(1-34) versus calcitriol and calcium. Winer KK, Ko CW, Reynolds JC, Dowdy K, Keil M, Peterson D, Gerber LH, McGarvey C, Cutler GB Jr. J Clin Endocrinol Metab. 2003 Sep;88(9):4214-20.

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