Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
83 participants
INTERVENTIONAL
2007-09-30
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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1
Alendronate 70 mg every 2 weeks
alendronate
alendronate 70 mg every 2 weeks
Calcium/Vitamin D
Calcium 500 mg and vitamin D supplementation according to serum level
2
Alendronate 70 mg placebo tablet every 2 weeks
Calcium/Vitamin D
Calcium 500 mg and vitamin D supplementation according to serum level
placebo
identical placebo every 2 weeks
Interventions
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alendronate
alendronate 70 mg every 2 weeks
Calcium/Vitamin D
Calcium 500 mg and vitamin D supplementation according to serum level
placebo
identical placebo every 2 weeks
Eligibility Criteria
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Inclusion Criteria
* Menopausal since at least 6 months
* Baseline lumbar BMD from -1 till -2.5
Exclusion Criteria
* 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
45 Years
60 Years
FEMALE
No
Sponsors
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University Hospital of Mont-Godinne
OTHER
Responsible Party
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Boutsen Yves
professeur
Principal Investigators
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Yves R Boutsen, MD
Role: PRINCIPAL_INVESTIGATOR
Locations
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University (UCL) Louvain Hospital in Mont-Godinne
Yvoir, Namur, Belgium
Countries
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Other Identifiers
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MG/OP 001
Identifier Type: -
Identifier Source: org_study_id
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