Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34

Status

Completed

Phase

Phase 2

Enrollment

27 participants (actual)

Sponsor

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

Design

Randomized · Open label (no masking)

Countries

1 country

United States

Start

Oct 1991

Primary completion

Mar 2014

Completion

Apr 2014

First posted

4 Nov 1999 (estimated)

Last update posted

15 Dec 2015 (estimated)

Conditions

Hypoparathyroidism

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.

• Experimental

  PTH 1-34

  All patients received twice daily synthetic Human Parathyroid Hormone 1-34.

• Experimental

  Calcitriol & Calcium

  All patients received twice daily Calcitriol and Calcium 1000mg divided into four doses daily.

1. Serum Calcium Level

   Time frame · 3 years

   Registry description

   Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = mmol/liter, normal range 2.05-2.5. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.

2. Urine Calcium Excretion Level

   Time frame · 3 years

   Registry description

   Measurements were taken1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = mmol/24 h, normal range 1.25-6.25. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.