ExBonAdAsia Study: A Study of Once Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.

Roche

Status and phase: Completed; Phase 4

Conditions: Post Menopausal Osteoporosis

Treatments: Drug: ibandronate [Bonviva/Boniva]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00545090

ML19937

Details and patient eligibility

About

This single arm study will continue drug safety surveillance, and assessment of adherence, in patients with postmenopausal osteoporosis who have received monthly oral Bonviva in ML19930, the BonAdAsia study. All patients completing 6 months in ML19930 will continue to receive Bonviva (150mg po, monthly) for an additional 6 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Enrollment: 561 patients

Sex: Female

Ages: Under 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients responding to oral monthly Bonviva during the BonAdAsia study;
• willing to continue Bonviva treatment for a further 6 months.

Exclusion criteria

• none specified.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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561 participants in 1 patient group

1

Experimental group

Treatment:

Drug: ibandronate [Bonviva/Boniva]