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

Primary Purpose

Osteoporosis

Status
Recruiting
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Edirol
Sponsored by
Shinshu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring The changes of bone mineral density and bone turnover markers

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A

Sites / Locations

  • Yukio NakamuraRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Non-Alfacaocidol

Alfacalcidol

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Number of Participants with bone mineral density as a Measure of bone quality
Bone mineral density will be evaluated at each time point
Number of Participants with bone mineral density as a Measure of bone quality
Bone mineral density will be evaluated at each time point

Full Information

First Posted
November 24, 2014
Last Updated
September 20, 2021
Sponsor
Shinshu University
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1. Study Identification

Unique Protocol Identification Number
NCT02306187
Brief Title
The Effectiveness of Eldecalcitol in the Bisphosphonate Non-respondered-patients With Osteoporosis
Official Title
The Effectiveness of Eldecalcitol in the Osteoporotic Patients Who Are Bisphosphonate Non-responders After Long-term Bisphosphonate Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 2014 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shinshu University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
The changes of bone mineral density and bone turnover markers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non-Alfacaocidol
Arm Type
Experimental
Arm Description
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.
Arm Title
Alfacalcidol
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Edirol
Other Intervention Name(s)
Eldecalcitol
Intervention Description
Edirol 0.5 or 0.75ug once every day oral treatment for at least 1 year after initial visit.
Primary Outcome Measure Information:
Title
Number of Participants with bone turnover markers as a Measure of bone quality
Description
Bone formation and bone absorption markers will be evaluated at each time point
Time Frame
At 4 months after the initial treatment
Title
Number of Participants with bone turnover markers as a Measure of bone quality
Description
Bone formation and bone absorption markers will be evaluated at each time point
Time Frame
At 1 year after the initial treatment
Secondary Outcome Measure Information:
Title
Number of Participants with bone mineral density as a Measure of bone quality
Description
Bone mineral density will be evaluated at each time point
Time Frame
At 4 months after the initial treatment
Title
Number of Participants with bone mineral density as a Measure of bone quality
Description
Bone mineral density will be evaluated at each time point
Time Frame
At 1 year after the initial treatment

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of Osteoporosis Must be able to swallow tablets Exclusion Criteria: N/A
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yukio Nakamura, MD, PhD
Phone
+81-263-37-2659
Email
yxn14@aol.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yukio Nakamura, MD, PhD
Organizational Affiliation
Shinshu University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yukio Nakamura
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
3908621
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yukio Nakamura, MD, PhD
Phone
+81-263-37-2659
Email
yxn14@aol.jp
First Name & Middle Initial & Last Name & Degree
Yukio Nakamura, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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