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Efficacy:
To investigate changes of structural bone properties in vivo using 3DpQCT ("Xtreme" CT, Scanco) in monthly oral ibandronate therapy for women with postmenopausal osteoporosis.
Major structural bone parameters which determine bone strength and predict fracture risk earlier and more precisely are measurable in vivo by 3DpQCT.
Safety:
To assess the tolerability and safety of ibandronate therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ibandronate | Active Comparator | 150 mg ibandronate monthly plus 500mg calcium and 800 UI vitamin D daily |
|
| 2 | Placebo Comparator | placebo monthly plus 500mg calcium and 800 UI vitamin D daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ibandronate, calcium and vitamin D | Drug | 1: 150 mg ibandronate monthly plus 500mg calcium and 800 UI vitamin D daily or |
|
| Measure | Description | Time Frame |
|---|---|---|
| BV/TV and trab. Sp. measured by 3D pQCT device | Baseline and after 3, 6, 9 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dieter Felsenberg, Prof. Dr. | Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin, Berlin, 12200, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin | Berlin | 12200 | Germany |
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| placebo,calcium and vitamin D | Drug | 2: placebo monthly plus 500mg calcium and 800 UI vitamin D daily |
|
| 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 |
| D002118 | Calcium |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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