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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00398931
First received: November 10, 2006
Last updated: September 26, 2014
Last verified: September 2014
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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: January 1998
Study Completion Date: September 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   60 Years to 86 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398931

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00398931     History of Changes
Other Study ID Numbers: 0217-051, 2006_558
Study First Received: November 10, 2006
Last Updated: September 26, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 20, 2014