Back to resultsExBonAdAsia Study: A Study of Once Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.
Primary Purpose
Post Menopausal Osteoporosis
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
ibandronate [Bonviva/Boniva]
Sponsored by
About this trial
This is an interventional treatment trial for Post Menopausal Osteoporosis
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
SAEs, AEs including fractures, adherence to treatment, clinical improvement, osteoporosis symptoms
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00545090
Brief Title
ExBonAdAsia Study: A Study of Once Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.
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 Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Menopausal Osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
561 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ibandronate [Bonviva/Boniva]
Intervention Description
150mg po monthly for 6 months
Primary Outcome Measure Information:
Title
SAEs, AEs including fractures, adherence to treatment, clinical improvement, osteoporosis symptoms
Time Frame
Throughout study
10. Eligibility
Sex
Female
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Hong Kong
ZIP/Postal Code
852
Country
Hong Kong
City
Jakarta
ZIP/Postal Code
10430
Country
Indonesia
City
Makassar
ZIP/Postal Code
90174
Country
Indonesia
City
Surabaya
ZIP/Postal Code
60286
Country
Indonesia
City
Manila
ZIP/Postal Code
1015
Country
Philippines
City
Quezon City
ZIP/Postal Code
1100
Country
Philippines
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
City
Taipei
ZIP/Postal Code
00112
Country
Taiwan
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
ExBonAdAsia Study: A Study of Once Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.
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