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Effects of LY333334 in the Treatment of Postmenopausal Women With Osteoporosis
The primary objective of this study is to demonstrate a reduction in the proportion of new vertebral fractures in postmenopausal women with osteoporosis following 3-years of treatment with 20 and 40 mcg/day of teriparatide plus calcium and vitamin D compared with calcium and vitamin D alone.
Details
| Lead sponsor | Eli Lilly and Company |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 1637 |
| Start date | 1996-08 |
| Completion | 1999-04 |
Conditions
- Osteoporosis, Postmenopausal
Interventions
- teriparatide
- teriparatide
- Placebo
- Calcium Supplement
- Vitamin D Supplement
Primary outcomes
- To demonstrate a reduction in the proportion of patients with new vertebral fractures (by spinal x-ray) following 3-year treatment with 20 and 40 micrograms/day of LY333334 plus calcium and vitamin D compared with calcium and vitamin D alone. — Baseline, randomization, 24 , 36, and 60 months
Countries
United States, Argentina, Australia, Austria, Belgium, Canada, Czechia, Denmark, Finland, Hungary, Israel, Italy, Netherlands, New Zealand, Norway, Poland, Sweden