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The purpose of this study is to evaluate the effect of alfacalcidol 1 µg daily on the number of fallers in postmenopausal, alendronate-treated, osteopenic or osteoporotic women.
primary outcome = number of fallers (patients with at least one locomotor fall incl.mixed falls)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | alfacalcidol 1µg/d |
|
| 2 | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alfacalcidol | Drug | alfacalcidol 1 µg once daily, oral, for 3 years |
| |
| Measure | Description | Time Frame |
|---|---|---|
| primary outcome: number of fallers (patients with at least one locomotor fall incl.mixed falls) | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| secondary outcome: number of falls (locomotor falls, incl.mixed falls), all falls/fallers, neuromuscular parameters, BMD, biochemical parameters of calcium and bone metabolism; cognition and moods; muscle biopsies | 3 years |
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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, Germany | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin | Berlin | 12200 | Germany | |||
| Centre for Muscle and Bone Research, Aerpah-Kliniken Esslingen |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| D001851 | Bone Diseases, Metabolic |
| D010024 | Osteoporosis |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C008088 | alfacalcidol |
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| placebo |
| Drug |
placebo once daily, oral, for 3 years |
|
| Stuttgart |
| 73732 |
| Germany |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |