Post Menopausal Osteoporosis
Conditions
Brief summary
This 2 arm study will assess the impact of bone marker feedback, using blood sampling and communication of results at week 5, on persistence to monthly Bonviva (150mg po) in women with post-menopausal osteoporosis. The study will also assess safety, quality of life and patient satisfaction. All patients will receive Bonviva 150mg po monthly, and will be randomized into the bio-feedback or no bio-feedback study arms. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Interventions
150mg po monthly for 12 months (with feedback)
Sponsors
GlaxoSmithKline
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ambulatory, post-menopausal women who would benefit from bisphosphonate treatment; * \>55 years of age; * naive to bisphosphonate therapy, or lapsed bisphosphonate users \>=6 months.
Exclusion criteria
* inability to stand or sit in an upright position for at least 60 minutes; * hypersensitivity to bisphosphonates; * treatment with other drugs affecting bone metabolism; * history of major upper gastrointestinal disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of percentage of patients with persistence to >=10/12 administrations of Bonviva in feedback and no feedback group | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Differences between groups in persistence | 6 months |
| QoL and patient satisfaction | 6 and 12 months |
Countries
France
Outcome results
None listed