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

Phase 4

Completed

• Conditions: Post Menopausal Osteoporosis
• Interventions: Drug: ibandronate [Bonviva/Boniva]

• Registration Number: NCT00545090
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2007-10-16
• Study First Submitted QC: 2007-10-16
• Study First Posted: 2007-10-17
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-08
• Last Update Posted: 2016-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 561

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	ibandronate [Bonviva/Boniva]	-

Primary Outcome Measures

Name	Time	Method
SAEs, AEs including fractures, adherence to treatment, clinical improvement, osteoporosis symptoms	Throughout study