The Optimal Long Term Treatment Strategy of Anti-resorptive Medications---The Extension of Denosumab Sequential Therapy
Study Details
Study Description
Brief Summary
This study is to investigate whether the alternating use of Prolia (Denosumab) and Aclasta (Zoledronic acid) can continue to increase bone density.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 4 |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Persistent treatment of Denosumab: persistent denosumab for 7 years |
Drug: Denosumab
Active comparator: persistent treatment of denosumab. Experimental: alternating treatment with zoledronate and denosumab
Other Names:
|
Experimental: Alternating treatment of Denosumab and Zoledronic acid alternating treatment of Denosumab and Zoledronic acid for 7 years |
Drug: Denosumab
Active comparator: persistent treatment of denosumab. Experimental: alternating treatment with zoledronate and denosumab
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Bone mineral density of femoral neck Bone mineral density of femoral neck [7 years]
Bone mineral density of femoral neck
Secondary Outcome Measures
- Bone mineral density of lumbar spine [7 years]
Bone mineral density of lumbar spine
- Bone mineral density of total hip [7 years]
Bone mineral density of total hip
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Postmenopausal women or men over 50 years old
-
Denosumab treatment for at least two years and less than three years (up to five doses).
Exclusion Criteria:
-
. Estimated glomerular filtration rate <35 ml/min.
-
Malignancy
-
Continuous steroid treatment, hormone therapy or other medical treatment affecting bone metabolism
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Secondary osteoporosis
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Metabolic bone diseases
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Contraindications to ZOL
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Patients older than 80 years old
-
Hypocalcemia
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | National Taiwan University Hospital, Yunlin branch | Douliu | Yunlin County | Taiwan | 640 |
Sponsors and Collaborators
- National Taiwan University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 202107164MINC