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Comparison of a 2-Year Therapy of Teriparatide Alone and Its Sequential Use for 1 Year, With or Without Raloxifene HCl, in the Treatment of Severe Postmenopausal Osteoporosis
The primary purpose of the study is to compare 3 different osteoporosis therapies following one year of teriparatide.In the first year,all eligible patients received open-label teriparatide 20 micrograms/day.After 1 year, patients are randomly assigned to one of 3 possible follow-up treatment regimens for the second 12 months: continuation of teriparatide, switch to raloxifene, or no pharmacological treatment(other than the calcium and vitamin D supplements that everyone receives). Patients are stratified into 3 subsets: (a) patients who have never received any anti-osteoporosis treatment before; (b) patients who received prior antiresorptive treatment successfully; (c) patients who failed to respond adequately to prior antiresorptive drugs (such as bisphosphonates or raloxifene) in the past. These latter patients are not randomized at month 12 but will continue treatment with teriparatide 20 micrograms/day throughout the second year.
Details
| Lead sponsor | Eli Lilly and Company |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 810 |
| Start date | 2002-08 |
| Completion | 2005-11 |
Conditions
- Osteoporosis, Postmenopausal
Interventions
- Teriparatide
- Raloxifene
Primary outcomes
- Lumbar spine BMD after 24 months.
Countries
Germany