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. |
ClinicalTrials.gov Identifier: NCT00398931 |
Recruitment Status :
Completed
First Posted : November 14, 2006
Last Update Posted : February 3, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 |

- Total hip bone mineral density (BMD)
- BMD of femoral neck, trochanter, and lumbar spine
- Biochemical markers of bone turnover

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, Learn About Clinical Studies.
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

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
Study Director: | Medical Monitor | Merck Sharp & Dohme LLC |
Other Publications:
Responsible Party: | Organon and Co |
ClinicalTrials.gov Identifier: | NCT00398931 |
Other Study ID Numbers: |
0217-051 2006_558 |
First Posted: | November 14, 2006 Key Record Dates |
Last Update Posted: | February 3, 2022 |
Last Verified: | February 2022 |
Osteoporosis Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
Metabolic Diseases Alendronate Physiological Effects of Drugs Bone Density Conservation Agents |