The Optimal Long Term Treatment Strategy of Anti-resorptive Medications---The Extension of Denosumab Sequential Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Optimal Long Term Treatment Strategy of Anti-resorptive Medications---The Extension of Denosumab Sequential Therapy

Conditions
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Osteoporosis, Bone Mineral Density

Intervention / Treatment
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* Drug: Denosumab


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: 80 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: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Persistent treatment of Denosumab:<br>persistent denosumab for 7 years | Drug: Denosumab<br>* Active comparator: persistent treatment of denosumab. Experimental: alternating treatment with zoledronate and denosumab<br>* Other names: Zoledronic acid;|
| Experimental: Alternating treatment of Denosumab and Zoledronic acid<br>alternating treatment of Denosumab and Zoledronic acid for 7 years | Drug: Denosumab<br>* Active comparator: persistent treatment of denosumab. Experimental: alternating treatment with zoledronate and denosumab<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 femoral neck Bone mineral density of femoral neck | Bone mineral density of femoral neck | 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density of lumbar spine | Bone mineral density of lumbar spine | 7 years | 
| Bone mineral density of total hip | Bone mineral density of total hip | 7 years | 

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