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

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Organon

Status and phase

Completed
Phase 3

Conditions

Osteoporosis, Postmenopausal

Treatments

Drug: MK0217, alendronate sodium / Duration of Treatment : 5 Years
Drug: Comparator : placebo (unspecified) /Duration of Treatment : 5 Years

Study type

Interventional

Funder types

Industry

Identifiers

NCT00398931
2006_558
0217-051

Details and patient eligibility

About

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.

Enrollment

1,099 patients

Sex

Female

Ages

60 to 86 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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