Postmenopausal Osteoporosis
Conditions
Brief summary
This 2 arm study will assess the impact of Bone Marker Feedback (BMF), using blood sampling and communication of the results at 2 months, on adherence to monthly Bonviva (150mg po) in women with post-menopausal osteoporosis. Patients will be randomized into either 1) a group which receives bone marker feedback or 2)a group which does not receive feedback on the results. The study will also assess patient satisfaction with treatment with once monthly Bonviva. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Interventions
150mg po monthly for 6 months (+ feedback)
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* ambulatory post-menopausal women with osteoporosis; * 55-85 years of age; * eligible for bisphosphonate treatment; * naive to bisphosphonate therapy, or lapsed users (last bisphosphonate intake \> 6 months ago).
Exclusion criteria
* inability to stand or sit in an upright position for at least 60 minutes; * inability to swallow a tablet whole; * hypersensitivity to bisphosphonates; * administration of any drug, or presence of active disease, known to influence bone metabolism; * uncorrected hypocalcemia or other bone disturbances of bone and mineral metabolism; * history of major upper gastrointestinal disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of percentage of patients with >=83% adherence to Bonviva in feedback vs no feedback group | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Patient satisfaction by OPSAT-Q and OPPS. | 6 months |
| Tolerability; SAEs. | Throughout study |
Countries
Austria, Belgium, Greece, Ireland, Luxembourg
Outcome results
None listed