Synthetic human parathyroid hormone 1-34 vs calcitriol and calcium in the treatment of hypoparathyroidism.
K K Winer, J A Yanovski, G B Cutler
https://pubmed.ncbi.nlm.nih.gov/8773636Completed
Phase 2
Age: 17Years - 69Years
All Genders
ID00001304
Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34
Led by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Updated on 2015-12-15
27
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34
Who Can Participate
Age: 17Years - 69Years
All Genders
Eligibility Criteria
You may qualify if you...
- INCLUSION CRITERIA:
This study will include patients (ages 17-69) with biochemically confirmed hypoparathyroidism.
EXCLUSION CRITERIA
Women who are pregnant will be excluded.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Status Unknown
Loading map...
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
A randomized, cross-over trial of once-daily versus twice-daily parathyroid hormone 1-34 in treatment of hypoparathyroidism.
K K Winer, J A Yanovski, B Sarani...
https://pubmed.ncbi.nlm.nih.gov/9768650Synthetic human parathyroid hormone 1-34 replacement therapy: a randomized crossover trial comparing pump versus injections in the treatment of chronic hypoparathyroidism.
Karen K Winer, Bo Zhang, Joseph A Shrader...
https://pubmed.ncbi.nlm.nih.gov/22090268Long-term treatment of hypoparathyroidism: a randomized controlled study comparing parathyroid hormone-(1-34) versus calcitriol and calcium.
Karen K Winer, Chia Wen Ko, James C Reynolds...
https://pubmed.ncbi.nlm.nih.gov/12970289Effects of once versus twice-daily parathyroid hormone 1-34 therapy in children with hypoparathyroidism.
Karen K Winer, Ninet Sinaii, Donna Peterson...
https://pubmed.ncbi.nlm.nih.gov/18492754