The Effectiveness of Eldecalcitol in the Bisphosphonate Non-respondered-patients With Osteoporosis

Study Overview
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Brief Summary
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In the patients with osteoporosis, bisphosphonates (BPs) are a golden standard treatment. However, the bone turnover markers or the bone mineral density (BMD) are not improved in some osteoporotic patients even though they have taken BPs and alfacalcidol more than several years. In those case, the investigators better off prescribing BPs and Eldecalcitol, instead of BPs and Alfacalcitol.

Detailed Description
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Alfacalcitol and Eldecalcitol are the similar vitamin D drugs. However, Eldecalcitol is an improved vitamin D drug than Alfacalcitol. Therefore, we investigate the effectiveness of Eldecalcitol in this study.

Official Title
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The Effectiveness of Eldecalcitol in the Osteoporotic Patients Who Are Bisphosphonate Non-responders After Long-term Bisphosphonate Treatment

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: Edirol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Osteoporosis Must be able to swallow tablets Exclusion Criteria: N/A
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-Alfacaocidol<br>Ahead of Eldecalcitol treatment, this group has not taken Alfacaocidol before. Eldecalcitol: the commercial name is Edirol We prescribe Edirol 0.5 or 0.75ug per day into each patient. | Drug: Edirol<br>* Edirol 0.5 or 0.75ug once every day oral treatment for at least 1 year after initial visit.<br>* Other names: Eldecalcitol;|
| Experimental: Alfacalcidol<br>Ahead of Eldecalcitol treatment, this group has taken Alfacaocidol before. Eldecalcitol: the commercial name is Edirol We prescribe Edirol 0.5 or 0.75ug per day into each patient. | Drug: Edirol<br>* Edirol 0.5 or 0.75ug once every day oral treatment for at least 1 year after initial visit.<br>* Other names: Eldecalcitol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with bone turnover markers as a Measure of bone quality | Bone formation and bone absorption markers will be evaluated at each time point | At 4 months after the initial treatment | 
| Number of Participants with bone turnover markers as a Measure of bone quality | Bone formation and bone absorption markers will be evaluated at each time point | At 1 year after the initial treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with bone mineral density as a Measure of bone quality | Bone mineral density will be evaluated at each time point | At 4 months after the initial treatment | 
| Number of Participants with bone mineral density as a Measure of bone quality | Bone mineral density will be evaluated at each time point | At 1 year after the initial treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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The changes of bone mineral density and bone turnover markers