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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Post Menopausal Osteoporosis

Intervention: ibandronate [Bonviva/Boniva] (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Eligibility

Minimum age: N/A. Maximum age: 85 Years. Gender(s): Female.

Criteria:

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 and Contacts

Hong Kong 852, Hong Kong

Jakarta 10430, Indonesia

Makassar 90174, Indonesia

Surabaya 60286, Indonesia

Manila 1015, Philippines

Quezon City 1100, Philippines

Changhua 500, Taiwan

Taichung 404, Taiwan

Taichung 407, Taiwan

Tainan 704, Taiwan

Taipei 00112, Taiwan

Taipei 100, Taiwan

Taoyuan 333, Taiwan

Bangkok 10330, Thailand

Bangkok 10400, Thailand

Chiang Mai 50200, Thailand

Khon Kaen 40002, Thailand

Additional Information

Starting date: August 2006
Last updated: August 17, 2015

Page last updated: August 23, 2015

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