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

Hoffmann-La Roche561 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

561

Conditions

Post Menopausal Osteoporosis

Interventions

ibandronate [Bonviva/Boniva]DRUG

150mg po monthly for 6 months

Eligibility

Sex: FEMALEMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (17)

Unnamed facility

Hong Kong, Hong Kong

Unnamed facility

Jakarta, Indonesia

Unnamed facility

Makassar, Indonesia

Outcomes

Primary Outcomes

SAEs, AEs including fractures, adherence to treatment, clinical improvement, osteoporosis symptoms

Time frame: Throughout study

Data from ClinicalTrials.gov

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