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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: November 14, 2006
Last Update Posted: February 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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.

Condition Intervention Phase
Osteoporosis, Postmenopausal Drug: MK0217, alendronate sodium / Duration of Treatment : 5 Years Drug: Comparator : placebo (unspecified) /Duration of Treatment : 5 Years Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Total hip bone mineral density (BMD)

Secondary Outcome Measures:
  • BMD of femoral neck, trochanter, and lumbar spine
  • Biochemical markers of bone turnover

Enrollment: 1099
Study Start Date: February 1998
Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 86 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00398931

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00398931     History of Changes
Other Study ID Numbers: 0217-051
First Submitted: November 10, 2006
First Posted: November 14, 2006
Last Update Posted: February 18, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Bone Density Conservation Agents
Physiological Effects of Drugs