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

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.

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Key information

Conditions

Post Menopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

Up to 85 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ibandronate [Bonviva/Boniva]

Drug

150mg po monthly for 6 months

Primary outcomes

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

Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open-label, Clinical Observation Extension Study to Assess Continuing Safety and Adherence in Patients With Postmenopausal Osteoporosis Receiving Monthly Oral Bonviva

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Oct 17, 2007
Registry last updated: Nov 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed