Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

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

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. Identifier: NCT00398931
Recruitment Status : Completed
First Posted : November 14, 2006
Last Update Posted : February 18, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE November 10, 2006
First Posted Date  ICMJE November 14, 2006
Last Update Posted Date February 18, 2015
Study Start Date  ICMJE February 1998
Actual Primary Completion Date October 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2006)
Total hip bone mineral density (BMD)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00398931 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2006)
  • BMD of femoral neck, trochanter, and lumbar spine
  • Biochemical markers of bone turnover
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE FLEX - Long-term Extension of FIT (Fracture Intervention Trial)(0217-051)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Osteoporosis, Postmenopausal
Intervention  ICMJE
  • Drug: MK0217, alendronate sodium / Duration of Treatment : 5 Years
  • Drug: Comparator : placebo (unspecified) /Duration of Treatment : 5 Years
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 11, 2009)
Original Enrollment  ICMJE
 (submitted: November 10, 2006)
Actual Study Completion Date  ICMJE October 2003
Actual Primary Completion Date October 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 60 Years to 86 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00398931
Other Study ID Numbers  ICMJE 0217-051
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP