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This study is to investigate whether the alternating use of Prolia (Denosumab) and Aclasta (Zoledronic acid) can continue to increase bone density.
This study intends to use a randomized trial to test whether the long-term treatment of Denosumab and Zoledronic acid can achieve sustained bone density progress and avoid the risk of rapid bone loss after the withdrawal of Denosumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Persistent treatment of Denosumab: | Active Comparator | persistent denosumab for 7 years |
|
| Alternating treatment of Denosumab and Zoledronic acid | Experimental | Alternating treatment with denosumab and zoledronic acid over a 7-year period: after entering the trial, patients received one year of zoledronic acid, followed by two years of denosumab, then switched back to zoledronic acid for one year, followed by another two years of denosumab, and finally received one more year of zoledronic acid. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Denosumab | Drug | Active comparator: persistent treatment of denosumab. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in lumbar spine bone mineral density | From enrollment to the end of treatment at 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total hip bone mineral density | From enrollment to the end of treatment at 3 years and 7 years | |
| Change in femoral neck bone mineral density | From enrollment to the end of treatment at 3 years and 7 years |
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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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Two parallel group would be selected. One group of participants keep their denosumab treatment for 7 years. Another group of participants accept two cycles of treatment (one year of zoledronate and two years of denosumab) and complete with one year of zoledronate.
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| Administer zoledronate and denosumab on an alternating schedule | Drug | In the experimental group, zoledronic acid was administered for one year, followed by two years of denosumab. This cycle was repeated, with the regimen concluding with one year of zoledronic acid. |
|
| Change in lumbar spine bone mineral density | From enrollment to the end of treatment at 7 years |
| Change in C-terminal telopeptide of type 1 collagen | From enrollment to the end of treatment at 3 years and 7 years |
| Change in Procollagen type 1 N-terminal propeptide | From enrollment to the end of treatment at 3 years and 7 years |
| Fractures | Number of Participants with clinical fractures and radiographic vertebral fractures | 3 & 7 years |
| Change in quality of life | From enrollment to the end of treatment at 3 years and 7 years |
| D009750 |
| Nutritional and Metabolic Diseases |