ExBonAdAsia Study: A Study of Once Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.
Information source: Hoffmann-La Roche
Information obtained from ClinicalTrials.gov on June 20, 2008
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, +1 973 235 5000
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: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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, China
JAKARTA 10430, Indonesia
MAKASSAR 90174, Indonesia
SURABAYA 60286, Indonesia
MANILA 1015, Philippines
QUEZON CITY 1100, Philippines
TAICHUNG 407, Taiwan
TAINAN 704, Taiwan
CHANGHUA 500, Taiwan
TAICHUNG 404, Taiwan
TAOYUAN 333, Taiwan
TAIPEI 100, Taiwan
TAIPEI 112, Taiwan
BANGKOK 10400, Thailand
BANGKOK 10330, Thailand
CHIANG MAI 50200, Thailand
KHON KAEN 40002, Thailand
Additional Information
Ending date: June 2008
Last updated: June 17, 2008
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