Osteopenia Clinical Trial
Official title:
Prevention of Postmenopausal Bone Loss in Osteopenic Women With Alendronate Given on a 70 mg Once-every Two Week Regimen: a 2-year, Double-blind, Placebo-controlled Clinical Trial.
The purpose of this study is to evaluate the efficacy of the intermittent administration of alendronate in a low dose, 70 mg once every two week, as osteoporosis prevention for menopausal, osteopenic patients, who don't want or can't receive an oestrogenic substitution treatment.
Status | Completed |
Enrollment | 83 |
Est. completion date | January 2012 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 45 Years to 60 Years |
Eligibility |
Inclusion Criteria: - 45 to 60 year-old women - Menopausal since at least 6 months - Baseline lumbar BMD from -1 till -2.5 Exclusion Criteria: - Bone disease other than osteopenia - Treatment with selective estrogen receptor modulator (SERMs), calcitonin or hormone replacement therapy within 6 monts prior to randomization - Former or current treatment with any bisphosphonate or bone forming agents - Chronic use of oral or iv corticosteroids - Any diagnosis of malignancy less than 12 months |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Belgium | University (UCL) Louvain Hospital in Mont-Godinne | Yvoir | Namur |
Lead Sponsor | Collaborator |
---|---|
University Hospital of Mont-Godinne |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | percentage of lumbar BMD modification after 2 years | 2 years | No | |
Secondary | percentage of hip BMD modification (total hip and sub-regions) | 2 years | No | |
Secondary | percentage of modification of bone remodeling markers | 2 years | No |
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