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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ibandronate [Bonviva/Boniva] | Drug | 150mg po monthly for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| SAEs, AEs including fractures, adherence to treatment, clinical improvement, osteoporosis symptoms | Throughout study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hong Kong | 852 | Hong Kong | ||||
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| 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 |
| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077557 | Ibandronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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