Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34

Completed · Phase 2

Conditions studied: Hypoparathyroidism

In brief

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.

Key facts

Study ID

NCT00001304

Run by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

People needed

27

Starts

1991-10-01

Expected to finish

2014-04-01

Last updated by the study team

2015-12-15

Who can join

Age: 17 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Women who are pregnant will be excluded.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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