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

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