Post-Menopausal Osteopenia
Conditions
Brief summary
This 2 arm study will compare the effect of oral Bonviva (150mg, monthly) and placebo on parameters of bone micro-architecture, assessed by CT scan, bone turnover and bone mineral density. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, and measurements will be taken at baseline, and at intervals over 2 years. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.
Interventions
150mg po monthly for 2 years
DRUGPlacebo
po monthly for 2 years
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* post-menopausal women, aged 55-75 years; * diagnosed osteopenia.
Exclusion criteria
* history of osteoporotic vertebral fracture; * contraindication to ibandronate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Trabecular BV/TV at distal radius of non-dominant arm | 12 arms |
Secondary
| Measure | Time frame |
|---|---|
| Trabecular BV/TV at distal radius of non-dominant arm | 6 months and 2 years |
| Bone density, trabecular BV/TV at distal tibia | 6 months, 1 and 2 years |
| Serum CTX | Intervals throughout study |
| Lumbar hip and wrist BMD | 1 and 2 years |
| AEs and laboratory parameters | Throughout study |
Countries
France
Outcome results
None listed