A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.

Roche

Status and phase: Completed; Phase 4

Conditions: Post Menopausal Osteoporosis

Treatments: Drug: ibandronate [Bonviva/Boniva]; Drug: Risedronate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00377234

MA19547

Details and patient eligibility

About

This 2 arm crossover study will evaluate patient reported preference for either once monthly Boniva (150mg p.o.) or once weekly risedronate (35mg p.o.). Patients with post-menopausal osteoporosis will be randomized to receive Boniva for 3 calendar months or risedronate for 12 weeks; they will then cross over to receive the alternative treatment for a further 12 weeks/3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Enrollment: 356 patients

Sex: Female

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ambulatory women with post-menopausal osteoporosis;
• patients who are bisphosphonate-naive, or who have previously received oral daily or i.v. bisphosphonate therapy (fulfilling certain criteria detailed in the protocol).

Exclusion criteria

• malignant disease diagnosed within previous 10 years (except for successfully resected basal cell cancer;) breast cancer within previous 20 years;
• inability to stand or sit upright for at least 60 minutes;
• disease/disorder/treatment with drugs known to influence bone metabolism.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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356 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: ibandronate [Bonviva/Boniva]

2

Active Comparator group

Treatment:

Drug: Risedronate