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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00001304
Date of registration: 03/11/1999
Prospective Registration: No
Primary sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Public title: Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34
Scientific title: Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34
Date of first enrolment: October 1991
Target sample size: 27
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00001304
Study type:  Interventional
Study design:   
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Karen K Winer, M.D.
Address: 
Telephone:
Email:
Affiliation:  Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Key inclusion & exclusion criteria

- INCLUSION CRITERIA:

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

EXCLUSION CRITERIA

Women who are pregnant will be excluded.



Age minimum: 17 Years
Age maximum: 69 Years
Gender: All
Health Condition(s) or Problem(s) studied
Hypoparathyroidism
Intervention(s)
Drug: Synthetic Human Parathyroid Hormone 1-34
Drug: Calcitriol & Calcium
Primary Outcome(s)
Serum Calcium Level [Time Frame: 3 years]
Urine Calcium Excretion Level [Time Frame: 3 years]
Secondary Outcome(s)
Serum 1,25-hydroxyvitamin D Level [Time Frame: 3 years]
Serum Magnesium Level [Time Frame: 3 years]
Serum Phosphorus Level [Time Frame: 3 years]
Urinary Creatinine Clearance [Time Frame: 3 years]
Serum 25-hydroxyvitamin D Level [Time Frame: 3 years]
Secondary ID(s)
92-CH-0011
920011
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 15/12/2015
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00001304
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