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

NCT00398931 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1099

Last updated 2022-02-03

No results posted yet for this study

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

DRUG

MK0217, alendronate sodium / Duration of Treatment : 5 Years

DRUG

Comparator : placebo (unspecified) /Duration of Treatment : 5 Years

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
86 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-02-28
Primary Completion
2003-10-31
Completion
2003-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00398931 on ClinicalTrials.gov