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This study will test the safety and efficacy of AAE581 in increasing Lumbar Spine bone mineral density (BMD) at 12 months, by Dexa-scan (DXA) in postmenopausal women with osteoporosis.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AAE581 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Lumbar spine BMD and total hip BMD after 1 year treatment | ||
| Safety and tolerability of one year treatment with different doses |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of the different doses on BMD of lumbar spine, femoral neck, total hip, forearm and total body | ||
| Effect of the different doses on markers for bone formation and bone resorption | ||
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Structural information on cortical and trabecular bone at different anatomic sites after 6 and 12 months of treatment |
| Histological information on bone biopsy after 12 months of treatment |