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

Postmenopausal Osteoporosis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT00493532
• Other study ID #: ML20882
• Status: No longer available
• Phase: Phase 4
• First received: June 27, 2007
• Last updated: November 1, 2016
• Start date: June 2007
• Est. completion date: December 2010

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Expanded Access

Clinical Trial 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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 80 Years

Eligibility

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).

Study Design

N/A

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

Intervention

Drug:
• ibandronate [Bonviva/Boniva]
3mg iv every 3 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Taiwan,