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

An Open Label Study to Evaluate the Effect on Bone Mineral Density, and the Safety, of Quarterly Intravenous Bonviva in Patients With Post-menopausal Osteoporosis.

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT00493532
Enrollment
Unknown
Registered
2007-06-28
Start date
2007-06-30
Completion date
2010-12-31
Last updated
2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopausal Osteoporosis

Brief summary

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.

Interventions

3mg iv every 3 months

Sponsors

Hoffmann-La Roche
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
FEMALE
Age
No minimum to 80 Years
Healthy volunteers
No

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).

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026