The Optimal Sequential Therapy After Long Term Denosumab Treatment
NCT ID: NCT05091099
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
44 participants
INTERVENTIONAL
2022-01-10
2025-11-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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On time Zoledronate
Zoledronate would be given (one dose for one year) after the completiong of denosumab on time
zoledronate
On time Zoledronate: Zoledronate would be given (one dose for one year) after the completiong of denosumab on time
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).
Alendronate and Zoledronate
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).
Interventions
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zoledronate
On time Zoledronate: Zoledronate would be given (one dose for one year) after the completiong of denosumab on time
Alendronate and Zoledronate
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Continuous Denosumab treatment for at least three years (up to six doses).
Exclusion Criteria
2. Metabolic bone diseases
3. Active or prior malignancy
4. Ongoing systemic glucocorticoid therapy
5. Current use of hormone replacement therapy
6. Current use of any medication known to affect bone metabolism
7. Prior use of any osteoporosis medication other than denosumab
8. Estimated glomerular filtration rate (eGFR) \< 40 mL/min
9. Known hypersensitivity to zoledronic acid
10. Hypocalcemia
11. Any other contraindication to zoledronic acid
12. Age \> 85 years
13. Esophageal abnormalities that delay esophageal emptying (e.g., esophageal stricture, achalasia)
14. Inability to stand or sit upright for at least 30 minutes
50 Years
85 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Locations
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National Taiwan University Hospital, Yunlin branch
Douliu, Yunlin County, Taiwan
Countries
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Other Identifiers
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202108044MINA
Identifier Type: -
Identifier Source: org_study_id
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