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| Sponsor: | Hoffmann-La Roche |
|---|---|
| Information provided by: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00545090 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Post-Menopausal Osteoporosis |
Drug: ibandronate [Bonviva/Boniva] |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | An Open-Label, Clinical Observation Extension Study to Assess Continuing Safety and Adherence in Patients With Postmenopausal Osteoporosis Receiving Monthly Oral Bonviva |
| Enrollment: | 561 |
| Study Completion Date: | June 2008 |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: ibandronate [Bonviva/Boniva]
150mg po monthly for 6 months
|
Eligibility| Ages Eligible for Study: | up to 85 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| China | |
| HONG KONG, China, 852 | |
| Indonesia | |
| JAKARTA, Indonesia, 10430 | |
| MAKASSAR, Indonesia, 90174 | |
| SURABAYA, Indonesia, 60286 | |
| Philippines | |
| MANILA, Philippines, 1015 | |
| QUEZON CITY, Philippines, 1100 | |
| Taiwan | |
| TAICHUNG, Taiwan, 407 | |
| TAINAN, Taiwan, 704 | |
| CHANGHUA, Taiwan, 500 | |
| TAICHUNG, Taiwan, 404 | |
| TAOYUAN, Taiwan, 333 | |
| TAIPEI, Taiwan, 100 | |
| TAIPEI, Taiwan, 112 | |
| Thailand | |
| KHON KAEN, Thailand, 40002 | |
| BANGKOK, Thailand, 10330 | |
| CHIANG MAI, Thailand, 50200 | |
| BANGKOK, Thailand, 10400 | |
| Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
More Information
| Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
| Study ID Numbers: | ML19937 |
| Study First Received: | October 16, 2007 |
| Last Updated: | May 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00545090 History of Changes |
| Health Authority: | Philippines: Department of Health |
|
Ibandronic acid Musculoskeletal Diseases Physiological Effects of Drugs Osteoporosis, Postmenopausal Osteoporosis |
Bone Density Conservation Agents Bone Diseases, Metabolic Bone Diseases Pharmacologic Actions |