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PTH & Ibandronate Combination Study (PICS): Optimizing the Use of PTH With Boniva (Pilot Randomized Controlled Trial)
This study will test in several innovative ways, several different combinations of PTH and oral monthly ibandronate for the treatment of osteoporosis in postmenopausal women. The intension is to provide other options for treatment than the current standard 2 year course of drug therapy. These options may lead to treatment where the two years of therapy are spread over several years.
Details
| Lead sponsor | University of California, San Francisco |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | COMPLETED |
| Enrolment | 44 |
| Start date | 2008-05 |
| Completion | 2011-04 |
Conditions
- Osteoporosis
Interventions
- PTH(1-84)
- Ibandronate
- Placebo injection
- Placebo pills
Primary outcomes
- P1NP (ng/ml) Change From Baseline. — Baseline, 3 months
After an overnight fast, serum was drawn at baseline and 1, 3, 6, 12, 15, 18 and 24 months. Samples were stored at -70C until batch assayed in a central laboratory. Serum N-propeptide of type I collagen (P1NP) and C-terminal telopeptide of type I collagen (CTX) were measured by electrochemiluminescent immunoassay. Bone-specified alkaline phosphate (BAP) was measured by paramagnetic particle immunoassay. P1NP was the bone turnover marker upon which we based sample size calculations.
Countries
United States