BONCURE Study: A Study of Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis on Bisphosphonate Therapy.

Roche

Status and phase: Completed; Phase 3

Conditions: Post-Menopausal Osteoporosis

Treatments: Drug: Ibandronate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00545779

ML20430

Details and patient eligibility

About

This single arm study will assess participant preference for monthly Bonviva, versus daily or weekly alendronate or risedronate, in the treatment of postmenopausal osteoporosis. Participants currently on a daily or weekly regimen of bisphosphonate therapy (alendronate or risedronate) will answer a questionnaire to identify participants who may benefit from a monthly Bonviva regimen. Eligible participants will then discontinue their present bisphosphonate treatment, and switch to monthly Bonviva 150mg per oral (po). At the beginning and end of Bonviva treatment, all participants will complete an Osteoporosis Patient Satisfaction Questionnaire. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Enrollment: 677 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• post-menopausal women;
• >=3 months daily or weekly alendronate or risedronate for treatment or prevention of post-menopausal osteoporosis.

Exclusion criteria

• inability to stand or sit in an upright position for at least 60 minutes;
• hypersensitivity to bisphosphonates;
• treatment with other drugs affecting bone metabolism;
• abnormalities of the oesophagus, which delay oesophageal emptying.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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677 participants in 1 patient group

Ibandronate

Experimental group

Description:

Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.

Treatment:

Drug: Ibandronate