Comparing Pump With Subcutaneous Injection Delivery of PTH 1-34 in the Management of Chronic Hypoparathyroidism

Completed · Phase 2

Conditions studied: Hypoparathyroidism, Hypocalcemia, Autoimmune Polyendocrine Syndrome Type 1, Autosomal Dominant Hypocalcemia Type 1 (ADH1)

In brief

This randomized crossover study will evaluate the safety, efficacy, and pharmacodynamics of synthetic human PTH 1-34 (PTH) delivered by an insulin pump (omnipod) compared with twice- daily subcutaneous injections. We predict pump delivery of PTH will simultaneously normalize blood and urine mineral levels with minimal or no fluctuations throughout the day, thus resulting in a more physiologic pharmacodynamic profile because this method of delivery mimics normal parathyroid gland function. Furthermore, we hypothesize that pump therapy will require lower PTH doses and will normalize markers of bone turnover. We anticipate the improved metabolic control when PTH is delivered by pump will be evident both in adults with surgically induced hypoparathyroidism and in children with more severe forms of hypoparathyroidism where there is an unmet need for improved therapy.

Key facts

Study ID

NCT00743782

Run by

National Institutes of Health Clinical Center (CC)

People needed

21

Starts

2008-08-22

Expected to finish

2014-04-07

Last updated by the study team

2026-03-04

Who can join

Age: 7 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Subjects who meet any of the following criteria are not eligible for study entry:
• Presence of significant hepatic or kidney disease
• Pregnancy
• Patients who are calcium infusion dependent.
• Seizure disorder requiring antiepileptic medications

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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