Comparing Pump With Subcutaneous Injection Delivery of PTH 1-34 in the Management of Chronic Hypoparathyroidism
Status:
Completed
Trial end date:
2014-04-07
Target enrollment:
Participant gender:
Summary
This study will evaluate the safety, biological activity, and pharmacokinetics of PTH
delivered by subcutaneous injection compared with an infusion pump. We anticipate pump
delivery of PTH will be more physiologic because it mimics normal parathyroid gland secretion
of PTH. We expect that pump delivery will simultaneously normalize blood and urine calcium,
phosphorus and magnesium levels with minimal or no fluctuations throughout the day. Pump
therapy will require lower PTH doses and should normalize markers of bone turnover. We expect
the improved metabolic control during pump therapy will be especially evident in patients
with more severe forms of hypoparathyrodism where there is an unmet need for improved
therapy.
Phase:
Early Phase 1
Details
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)