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

Phase 1

Recruiting

• Conditions: Osteoporosis
• Interventions: Drug: Edirol

• Registration Number: NCT02306187
• Lead Sponsor: Shinshu University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-11-24
• Study First Submitted QC: 2014-11-28
• Study Start: 2014-12
• Study First Posted: 2014-12-03
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-21
• Primary Completion: 2022-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Clinical diagnosis of Osteoporosis
• Must be able to swallow tablets

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Exclusion Criteria

• N/A

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Non-Alfacaocidol	Edirol	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.
Alfacalcidol	Edirol	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants with bone turnover markers as a Measure of bone quality	At 1 year after the initial treatment	Bone formation and bone absorption markers will be evaluated at each time point

Secondary Outcome Measures

Name	Time	Method
Number of Participants with bone mineral density as a Measure of bone quality	At 1 year after the initial treatment	Bone mineral density will be evaluated at each time point

Trial Locations

Locations (1)

Yukio Nakamura; 🇯🇵 Matsumoto, Nagano, Japan