The Optimal Sequential Therapy After Long Term Denosumab Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Optimal Sequential Therapy After Long Term Denosumab Treatment

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: Alendronate


Participation Criteria
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Eligibility Criteria
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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 Secondary osteoporosis Metabolic bone diseases Contraindications to ZOL Patients older than 80 years old Hypocalcemia

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: On time Zoledronate<br>Zoledronate would be given (one dose for one year) after the completiong of denosumab on time | Drug: Alendronate<br>* 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).<br>* Other names: Zoledronic acid;|
| Experimental: Alendronate and Zoledronate<br>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). | Drug: Alendronate<br>* 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).<br>* Other names: Zoledronic acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density of lumbar spine | Bone mineral density of lumbar spine | one year | 

Secondary Outcome Measures

| Outcome Measure | 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 | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoporosis, denosumab, alendronate, zoledronic acid