Status:
COMPLETED
FLEX - Long-term Extension of FIT (Fracture Intervention Trial)(0217-051)
Lead Sponsor:
Organon and Co
Conditions:
Osteoporosis, Postmenopausal
Eligibility:
FEMALE
60-86 years
Phase:
PHASE3
Brief Summary
This study was conducted among women who had previously received alendronate for 3 to 6 years during the Fracture Intervention Trial (FIT). Participants in the FLEX study were randomly assigned to rec...
Eligibility Criteria
Inclusion
- To be eligible to participate in this study, women needed to have previously participated in the Fracture Intervention Trial (FIT) and to have been part of the group treated with alendronate in FIT
- They needed to have received at least 3 years of treatment with alendronate in the FIT trial
- In addition, their bone mineral density (BMD) at the hip needed to be better than it was at the start of FIT
Exclusion
- Patients were excluded if they had conditions that contraindicated alendronate therapy and if they might have used other medications for the treatment of osteoporosis
- Women were also excluded if BMD at the hip was below a certain level (T-score \<=-3.5); that is, if it were 3.5 standard deviations or more lower than the average for young adult women
Key Trial Info
Start Date :
February 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2003
Estimated Enrollment :
1099 Patients enrolled
Trial Details
Trial ID
NCT00398931
Start Date
February 1 1998
End Date
October 1 2003
Last Update
February 3 2022
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