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This study intends to investigate whether Alendronate and Zoledronate can prevent bone mineral density loss after long-term treatment with Denosumab.
This study intends to use a randomized trial to test whether Alendronate and Zoledronate can avoid the risk of rapid bone loss after the withdrawal of Denosumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| On time Zoledronate | Active Comparator | Zoledronate would be given (one dose for one year) after the completiong of denosumab on time |
|
| Alendronate and Zoledronate | Experimental | Alendronate would be given one month before the the completiong of denosumab and the following 3 months (Total four months). After the completion of Alendronate, Zoledronate would be given (one dose). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zoledronate | Drug | On time Zoledronate: Zoledronate would be given (one dose for one year) after the completiong of denosumab on time |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone mineral density of lumbar spine | Bone mineral density of lumbar spine | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Bone mineral density of femoral neck | Bone mineral density of femoral neck | one year |
| Bone mineral density of total hip | Bone mineral density of total hip |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital, Yunlin branch | Douliu | Yunlin County | 640 | Taiwan |
after application
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| D019386 | Alendronate |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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One arm accept on time zoledronic acid after long-tearm denosumab. Another arm accept alendronate for 4 months and then zoledronic acid after long-tearm denosumab.
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| Alendronate and Zoledronate | Drug | Alendronate and Zoledronate: Alendronate would be given one month before the the completiong of denosumab and the following 3 months (Total four months). After the completion of Alendronate, Zoledronate would be given (one dose). |
|
| one year |
| bone turnover markers | Changes of C-terminal telopeptide of type I collagen (CTX) and propeptide of procollagen type I (P1NP) | 13 months |
| clinical osteoporotic fracture | any incidence of clinical osteoporotic fracture | 1 year |
| D009750 |
| Nutritional and Metabolic Diseases |
| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |