Comparing Pump With Subcutaneous Injection Delivery of PTH 1-34 in the Management of Chronic Hypoparathyroidism
Drug: Synthetic Human Parathyroid Hormone 1-34
Early Phase 1
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Comparing Pump vs. Subcutaneous Injection Delivery of PTH 1-34 in the Management of Chronic Hypoparathyroidism|
- Assess the feasability of PTH 1-34 therapy via pump.
- This pilot study is being conducted to compare PTH therapy via pump vs. twice daily subcutaneous injections.
|Study Start Date:||August 22, 2008|
|Study Completion Date:||April 7, 2014|
|Primary Completion Date:||April 7, 2014 (Final data collection date for primary outcome measure)|
Prior studies (92-CH-0011) have 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. We are conducting a randomized crossover study comparing twice-daily subcutaneous injections vs. PTH pump therapy. We hypothesize that pump delivery of PTH 1-34, compared to twice-daily administration, will provide smoother metabolic control of serum mineral levels and normalization of urine mineral excretion. The two arms will be divided into an inpatient and an outpatient phase. There will be three inpatient admissions, baseline, 3 months, and 6 months. Subjects will be randomized to either pump therapy or to twice daily injections at the beginning of the study and will cross over to the alternate PTH delivery system (injections vs. pump) at the conclusion of the initial 3-month treatment period.
Patients between 10 and 70 years of age who have had chronic hypoparathyroidism for at least 1 year may be eligible for this study. Participants have two 10- 12-day hospital admissions and one 5-day admission. The first two inpatient admissions are separated by 3-month outpatient periods. Outpatient monitoring will require weekly blood tests and monthly urine tests to monitor mineral levels. After third hospital admission, patients will be placed on conventional therapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00743782
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Karen K Winer, M.D.||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|