Status:
COMPLETED
Comparing Pump With Subcutaneous Injection Delivery of PTH 1-34 in the Management of Chronic Hypoparathyroidism
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Hypoparathyroidism
Hypocalcemia
Eligibility:
All Genders
7-70 years
Phase:
PHASE2
Brief Summary
This study will evaluate the safety, biological activity, and pharmacokinetics of PTH delivered by subcutaneous injection compared with an infusion pump. We anticipate pump delivery of PTH will be mor...
Detailed Description
Prior studies (92-CH-0011) have been important in establishing synthetic human parathyroid hormone 1-34 (PTH) as a beneficial treatment for hypoparathyroidism, superior to conventional therapy with ca...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- This study will include patients of both genders (ages 7-70) with biochemically confirmed chronic hypoparathyroidism of at least one year duration. Twenty-four subjects will be enrolled.
- EXCLUSION CRITERIA:
- Subjects who meet any of the following criteria are not eligible for the study:
- Pregnancy
- Patients who are calcium infusion dependent and/or do not respond to calcitriol therapy to maintain normal levels of serum calcium will be excluded.
- Seizure disorder requiring antiepileptic medications.
Exclusion
Key Trial Info
Start Date :
August 22 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00743782
Start Date
August 22 2008
End Date
April 7 2014
Last Update
November 27 2024
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892