NCT00398931

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,099 (actual)
• Sponsor: Organon and Co · Industry
• Sex: Female
• Age: 60 Years – 86 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoporosis, Postmenopausal

Interventions

Type	Name	Description
DRUG	MK0217, alendronate sodium / Duration of Treatment : 5 Years
DRUG	Comparator : placebo (unspecified) /Duration of Treatment : 5 Years

Timeline

• Start date: 1998-02-01
• Primary completion: 2003-10-01
• Completion: 2003-10-01
• First posted: 2006-11-14
• Last updated: 2022-02-03