Osteoporosis Prevention With Low Dose Alendronate
Information source: University Hospital of Mont-Godinne
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteopenia
Intervention: alendronate (Drug); Calcium/Vitamin D (Dietary Supplement); placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: University Hospital of Mont-Godinne Official(s) and/or principal investigator(s):
Yves R Boutsen, MD, Principal Investigator
Summary
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.
Clinical Details
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.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: percentage of lumbar BMD modification after 2 years
Secondary outcome: percentage of hip BMD modification (total hip and sub-regions)percentage of modification of bone remodeling markers
Eligibility
Minimum age: 45 Years.
Maximum age: 60 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
University (UCL) Louvain Hospital in Mont-Godinne, Yvoir, Namur 5530, Belgium
Additional Information
Starting date: September 2007
Last updated: May 28, 2013
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