A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva

Roche

Status and phase: Completed; Phase 4

Conditions: Post-Menopausal Osteoporosis

Treatments: Drug: ibandronate [Bonviva/Boniva]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00081653

MA17903

Details and patient eligibility

About

This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.

Enrollment: 719 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• successful completion of Bonviva study BM16549, with at least 75% compliance;
• ambulatory.

Exclusion criteria

• malignant disease diagnosed within the previous 12 years (except basal cell cancer that has been successfully removed);
• breast cancer diagnosed within the previous 22 years.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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719 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: ibandronate [Bonviva/Boniva]

Drug: ibandronate [Bonviva/Boniva]

2

Active Comparator group

Treatment:

Drug: ibandronate [Bonviva/Boniva]

Drug: ibandronate [Bonviva/Boniva]