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

Organon and Co1,099 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,099

Conditions

Osteoporosis, Postmenopausal

Interventions

MK0217, alendronate sodium / Duration of Treatment : 5 YearsDRUG

Comparator : placebo (unspecified) /Duration of Treatment : 5 YearsDRUG

Eligibility

Sex: FEMALEMin age: 60 YearsMax age: 86 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Total hip bone mineral density (BMD)

Secondary Outcomes

BMD of femoral neck, trochanter, and lumbar spine

Biochemical markers of bone turnover

Data from ClinicalTrials.gov

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