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

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ClinicalTrials.gov Identifier: NCT00398931
Recruitment Status : Completed
First Posted : November 14, 2006
Last Update Posted : February 3, 2022
Information provided by (Responsible Party):
Organon and Co

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1099 participants
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
Study Start Date : February 1998
Actual Primary Completion Date : October 2003
Actual Study Completion Date : October 2003

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 86 Years   (Adult, Older Adult)
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

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
Organon and Co
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Study Director: Medical Monitor Merck Sharp & Dohme LLC
Publications of Results:
Other Publications:

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Responsible Party: Organon and Co
ClinicalTrials.gov Identifier: NCT00398931    
Other Study ID Numbers: 0217-051
First Posted: November 14, 2006    Key Record Dates
Last Update Posted: February 3, 2022
Last Verified: February 2022
Additional relevant MeSH terms:
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Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Physiological Effects of Drugs
Bone Density Conservation Agents