A Study of Quarterly Intravenous Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.

Roche

Status

Conditions: Postmenopausal Osteoporosis

Treatments: Drug: ibandronate [Bonviva/Boniva]

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT00493532

ML20882

Details and patient eligibility

About

This single arm study will assess the efficacy and safety of quarterly intravenous Bonviva in women with post-menopausal osteoporosis. All patients will receive Bonviva 3mg i.v. every 3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.

Sex: Female

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• post-menopausal women with osteoporosis;
• <=80 years of age;
• naive to oral bisphosphonates, or have discontinued daily and/or weekly bisphosphonate treatment for >1 year.

Exclusion criteria

• metabolic bone disease other than post-menopausal osteoporosis;
• treatment with other drugs affecting bone metabolism within last 6 months;
• previous or current malignant disease (except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer).