A Study of Ibandronate [Bonviva/Boniva] and Alendronate in Female Patients With Post-Menopausal Osteoporosis

Condition(s) targeted: Post Menopausal Osteoporosis

Intervention: alendronate (Drug); ibandronate [Bonviva/Boniva] (Drug)

Phase: N/A

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

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.

Official title: Controllability and Real Life Efficacy of Bonviva 3 mg iv Quarterly vs. Oral Alendronate Generics

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: 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

Secondary outcome:

Pain intensity and reduction in use of analgesics

Quality of life and patients satisfaction

Degree of patient's mobility

Incidence of new osteoporotic fractures

Controllability and management of therapy by the physician

Patient baseline characteristics

User friendliness

Safety: AEs and SAEs

Minimum age: 55 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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

Marburg 35043, Germany

Starting date: April 2010
Last updated: August 17, 2015