Clinical trial
FLEX - Long-term Extension of FIT (Fracture Intervention Trial)(0217-051)
NCT00398931 · Organon and Co, Industry · Completed
Key facts
| NCT number | NCT00398931 |
|---|---|
| Title | FLEX - Long-term Extension of FIT (Fracture Intervention Trial)(0217-051) |
| Official title | A 5-year, Double-blind, Randomized, Placebo-controlled Extension Study to Examine the Long-term Safety and Efficacy of Oral Alendronate in Postmenopausal Women Who Previously Received Alendronate in Conjunction With the Fracture Intervention Trial |
| Lead sponsor | Organon and Co, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Osteoporosis, Postmenopausal |
| Intervention type | Drug |
| Interventions | MK0217, alendronate sodium / Duration of Treatment : 5 Years, Comparator : placebo (unspecified) /Duration of Treatment : 5 Years |
| Enrollment | 1,099 |
| Start date | Feb 1, 1998 |
| Primary completion | Oct 1, 2003 |
| Completion | Oct 1, 2003 |
| First posted | Nov 14, 2006 |
| Last update posted | Feb 3, 2022 |
At a glance
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: