A Study of Ibandronate [Bonviva/Boniva] and Alendronate in Female Patients With Post-Menopausal Osteoporosis
Completed
- Conditions
- Postmenopausal Osteoporosis
- Interventions
- Registration Number
- NCT01128257
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 6054
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
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Exclusion Criteria
- N/A
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 ibandronate [Bonviva/Boniva] - 2 alendronate -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method User friendliness 12 months Safety: AEs and SAEs 12 months Patient baseline characteristics 12 months Pain intensity and reduction in use of analgesics 12 months Quality of life and patients satisfaction 12 months Degree of patient's mobility 12 months Incidence of new osteoporotic fractures 12 months Controllability and management of therapy by the physician 12 months