Osteopenia
Conditions
Keywords
osteopenia, osteoporosis prevention, alendronate
Brief 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.
Interventions
DRUGalendronate
alendronate 70 mg every 2 weeks
DIETARY_SUPPLEMENTCalcium/Vitamin D
Calcium 500 mg and vitamin D supplementation according to serum level
DRUGplacebo
identical placebo every 2 weeks
Sponsors
University Hospital of Mont-Godinne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| percentage of lumbar BMD modification after 2 years | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| percentage of hip BMD modification (total hip and sub-regions) | 2 years |
| percentage of modification of bone remodeling markers | 2 years |
Countries
Belgium
Outcome results
None listed