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

Condition(s) targeted: Post-Menopausal Osteoporosis

Intervention: ibandronate [Bonviva/Boniva] (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000

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.

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: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

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).

TAIPEI 100, Taiwan

TAIPEI 112, Taiwan

TAICHUNG 404, Taiwan

TAINAN 704, Taiwan

TAOYUAN 333, Taiwan

TAIPEI 886, Taiwan

TAICHUNG 407, Taiwan

TAICHUNG 402, Taiwan

CHANGHUA 500, Taiwan

KAOHSIUNG 807, Taiwan

KAOHSIUNG 833, Taiwan

TAINAN 710, Taiwan

CHAI YI 613, Taiwan

KAOHSIUNG 804, Taiwan

Starting date: June 2007
Ending date: October 2008
Last updated: June 17, 2008