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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Post Menopausal Osteoporosis

Intervention: ibandronate [Bonviva/Boniva] (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hoffmann-La Roche

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

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.

Clinical Details

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.

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Mean change (%) in spinal BMD

Secondary outcome:

Mean change in hip BMD

Mean change in Serum CTX

Mean change in hip and spinal BMD

AEs and clinical fractures

Percentage change from baseline in OPSAT-Q

Eligibility

Minimum age: N/A. Maximum age: 80 Years. Gender(s): Female.

Criteria:

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).

Locations and Contacts

Chai Yi 613, Taiwan

Changhua 500, Taiwan

Kaohsiung 00833, Taiwan

Kaohsiung 804, Taiwan

Kaohsiung 807, Taiwan

Taichung 40705, Taiwan

Taichung 404, Taiwan

Taichung 402, Taiwan

Tainan 704, Taiwan

Tainan 710, Taiwan

Taipei 00112, Taiwan

Taipei 100, Taiwan

Taipei 886, Taiwan

Taoyuan 333, Taiwan

Additional Information

Starting date: June 2007
Last updated: August 17, 2015

Page last updated: August 23, 2015

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