Postmenopausal Osteoporosis
Conditions
Brief summary
This observational study will assess the compliance and persistence of patients, real life efficacy and safety of intravenously quarterly administered 3 mg ibandronate \[Bonviva/Boniva\] in comparison to oral alendronate generics in female patients with post-menopausal osteoporosis. The anticipated time of assessment is 12 months. The target sample size is 5000-7000 patients.
Interventions
DRUGalendronate
As prescribed by physician
As prescribed by physician
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients, \>/= 55 years of age * Postmenopausal osteoporosis * Patients who are in the opinion of the physician eligible to participate in this study
Exclusion criteria
* N/A
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of compliance and persistence of Bonviva therapy: Number of prescriptions, number of applied injections, number of taken oral medication, continuation and duration of treatment | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life and patients satisfaction | 12 months |
| Degree of patient's mobility | 12 months |
| Incidence of new osteoporotic fractures | 12 months |
| Pain intensity and reduction in use of analgesics | 12 months |
| Patient baseline characteristics | 12 months |
| User friendliness | 12 months |
| Safety: AEs and SAEs | 12 months |
| Controllability and management of therapy by the physician | 12 months |
Countries
Germany
Outcome results
None listed