Once Weekly Parathyroid Hormone for Osteoporosis
|Osteopenia Osteoporosis||Drug: Teriparatide Drug: Placebo teriparatide||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Primary Purpose: Treatment
|Official Title:||PTH Once Weekly Research (POWR)|
- Bone mineral density [ Time Frame: Months 6 and 12 ]
|Study Start Date:||December 2003|
|Study Completion Date:||September 2005|
|Primary Completion Date:||September 2005 (Final data collection date for primary outcome measure)|
Women will self-administer PTH injections daily for 4 weeks, then once weekly for 48 weeks
Synthetic human parathyroid hormone
Placebo Comparator: 2
Women will self-administer placebo injections daily for 4 weeks, then once weekly for 48 weeks
Drug: Placebo teriparatide
In osteoporosis, skeletal bone mass and strength are so reduced that fractures occur after only modest levels of mechanical stress that would not harm normal bone. Fractures of the hip, spine, and wrists are most typical, though fractures of the ribs, pelvis, and humerus also occur. Research has shown that hip fractures cause a 10% to 20% increase in mortality, and the cost of all osteoporotic fractures is estimated to be $6.14 billion in health care costs and lost earnings per year. The most common form of osteoporosis is postmenopausal osteoporosis. A reduction in bone mineral density of approximately 1% to 2% per year is observed for the first 3 to 5 years after the onset of menopause, then 0.5% to 1% per year thereafter.
PTH was recently approved by the FDA as a daily treatment for osteoporosis. However, PTH must be self-injected, is very expensive, and has been associated with worrisome side effects. The currently approved formulation of daily PTH self-injections is practical for only a small proportion of people with osteoporosis. A once weekly formulation could significantly decrease cost, difficulty of administration, and risks and side effects associated with daily use of PTH. A once weekly injection by a caregiver would also make PTH accessible to populations for whom daily self-injection may not be practical, such as the very elderly or those in assisted living or nursing homes. This study will evaluate the safety and effectiveness of once weekly PTH dosing for women with osteoporosis.
Women will be randomized to receive either PTH or placebo. Women will self-administer injections daily for 4 weeks, then once weekly for 48 weeks. All women will receive calcium and vitamin D supplements daily. Women will visit the clinic six times over the course of a year and will provide urine and blood samples at each visit. Bone mineral density will be measured at 6 and 12 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00065637
|United States, Maine|
|St Joseph Hospital|
|Bangor, Maine, United States, 04401|
|Principal Investigator:||Clifford Rosen, MD||St. Joseph Hospital Health Center|