Examination of Efficacy and Safety of Other Anti-Resorption Drugs After 2-year-Denosumab Therapy in Japanese Osteoporosis Patients

Study Overview
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Brief Summary
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The aim of this study is to examine the efficacy and adverse events in the following 3 groups in Japanese osteoporosis patients after 2-year-denosumab therapy: SERM and eldecalcitol treatment for 24 months Bisphosphonates and eldecalcitol treatment for 24 months Eldecalcitol treatment for 24 months

Official Title
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Examination of Efficacy and Safety of SERM or Bisphosphonates After 2-year-Denosumab Therapy in Japanese Osteoporosis Patients

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: SERM Viviant®Tablet 20mg and ELD Edirol®Tablet 0.75ug
* Drug: Bisphosphonates and ELD Edirol®Tablet 0.75ug
* Drug: ELD Edirol®Tablet 0.75ug


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: osteoporosis patients Exclusion Criteria: not osteoporosis patients who are allergic to the drugs, refused to do this research, or who are pregnant

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 120 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SERM plus ELD<br>To examine the effects of SERM plus ELD in osteoporosis patients | Drug: SERM Viviant®Tablet 20mg and ELD Edirol®Tablet 0.75ug<br>* To examine the effects of SERM and ELD in osteoporosis patients<br>Drug: Bisphosphonates and ELD Edirol®Tablet 0.75ug<br>* To examine the effects of BP and ELD in osteoporosis patients<br>Drug: ELD Edirol®Tablet 0.75ug<br>* To examine the effects of ELD in osteoporosis patients<br>|
| Active Comparator: BP plus ELD<br>To examine the effects of BP plus ELD in osteoporosis patients | Drug: SERM Viviant®Tablet 20mg and ELD Edirol®Tablet 0.75ug<br>* To examine the effects of SERM and ELD in osteoporosis patients<br>Drug: Bisphosphonates and ELD Edirol®Tablet 0.75ug<br>* To examine the effects of BP and ELD in osteoporosis patients<br>Drug: ELD Edirol®Tablet 0.75ug<br>* To examine the effects of ELD in osteoporosis patients<br>|
| Active Comparator: ELD alone<br>To examine the effects of ELD alone in osteoporosis patients | Drug: SERM Viviant®Tablet 20mg and ELD Edirol®Tablet 0.75ug<br>* To examine the effects of SERM and ELD in osteoporosis patients<br>Drug: Bisphosphonates and ELD Edirol®Tablet 0.75ug<br>* To examine the effects of BP and ELD in osteoporosis patients<br>Drug: ELD Edirol®Tablet 0.75ug<br>* To examine the effects of ELD in osteoporosis patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of bone mineral density in osteoporosis patients treated by SERM plus ELD, Bisphosphonate plus ELD, or ELD alone |  | Change from Baseline Values of bone mineral density at 2 years in each group |