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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00398931 |
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Date of registration:
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10/11/2006 |
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Primary sponsor: |
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Public title:
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FLEX - Long-term Extension of FIT (Fracture Intervention Trial)
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Scientific title:
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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 |
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Date of first enrolment:
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January 1998 |
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Target sample size:
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1099 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00398931 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Merck |
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Key inclusion & exclusion criteria
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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
Age minimum:
60 Years
Age maximum:
86 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Osteoporosis, Postmenopausal
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Intervention(s)
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Drug: Comparator : placebo (unspecified) /Duration of Treatment : 5 Years
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Drug: MK0217, alendronate sodium / Duration of Treatment : 5 Years
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Primary Outcome(s)
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Total hip bone mineral density (BMD)
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Secondary Outcome(s)
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Biochemical markers of bone turnover
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BMD of femoral neck, trochanter, and lumbar spine
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Secondary ID(s)
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2006_558
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MK0217-051
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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