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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:
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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:
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Hypoparathyroidism
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Parathyroid Hormone
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Vitamin D
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Calcium Metabolism
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Cyclic AMP
- Recruitment Keyword(s):
-
None
- Condition(s):
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Hypoparathyroidism
- Investigational Drug(s):
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PTH 1-34
- Investigational Device(s):
- None
- Intervention(s):
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Drug: PTH 1-34
- Supporting Site:
- National Institute of Child Health and Human Development
- Contact(s):
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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):
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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.
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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.
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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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Bethesda, Maryland 20892. Last update: 01/30/2009
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