ExBonAdAsia Study: A Study of Once Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.
An Open-label, Clinical Observation Extension Study to Assess Continuing Safety and Adherence in Patients With Postmenopausal Osteoporosis Receiving Monthly Oral Bonviva
1 other identifier
interventional
561
5 countries
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2006
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 16, 2007
CompletedFirst Posted
Study publicly available on registry
October 17, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedNovember 10, 2016
November 1, 2016
1.8 years
October 16, 2007
November 8, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
SAEs, AEs including fractures, adherence to treatment, clinical improvement, osteoporosis symptoms
Throughout study
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- patients responding to oral monthly Bonviva during the BonAdAsia study;
- willing to continue Bonviva treatment for a further 6 months.
You may not qualify if:
- none specified.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Unknown Facility
Hong Kong, 852, Hong Kong
Unknown Facility
Jakarta, 10430, Indonesia
Unknown Facility
Makassar, 90174, Indonesia
Unknown Facility
Surabaya, 60286, Indonesia
Unknown Facility
Manila, 1015, Philippines
Unknown Facility
Quezon City, 1100, Philippines
Unknown Facility
Changhua, 500, Taiwan
Unknown Facility
Taichung, 404, Taiwan
Unknown Facility
Taichung, 407, Taiwan
Unknown Facility
Tainan, 704, Taiwan
Unknown Facility
Taipei, 00112, Taiwan
Unknown Facility
Taipei, 100, Taiwan
Unknown Facility
Taoyuan District, 333, Taiwan
Unknown Facility
Bangkok, 10330, Thailand
Unknown Facility
Bangkok, 10400, Thailand
Unknown Facility
Chiang Mai, 50200, Thailand
Unknown Facility
Khon Kaen, 40002, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2007
First Posted
October 17, 2007
Study Start
August 1, 2006
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
November 10, 2016
Record last verified: 2016-11