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FLEX - Long-term Extension of FIT (Fracture Intervention Trial)(0217-051)

Osteoporosis, Postmenopausal Clinical Trial

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

Clinical Trial 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 receive alendronate (either 5 or 10 mg/day) or matching placebo during the next 5 years, in order to evaluate the effects of continuing or discontinuing alendronate treatment on bone mineral density and biochemical markers of bone turnover.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00398931
Study type Interventional
Source Organon and Co
Contact
Status Completed
Phase Phase 3
Start date February 1998
Completion date October 2003
View Details
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