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

September 20, 2021 updated by: Yukio Nakamura, Shinshu University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Nagano
      • Matsumoto, Nagano, Japan, 3908621
        • Recruiting
        • Yukio Nakamura

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-Alfacaocidol
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
Edirol 0.5 or 0.75ug once every day oral treatment for at least 1 year after initial visit.
Other Names:
  • Eldecalcitol
Experimental: Alfacalcidol
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
Edirol 0.5 or 0.75ug once every day oral treatment for at least 1 year after initial visit.
Other Names:
  • Eldecalcitol

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shinshu University

Investigators

  • Principal Investigator: Yukio Nakamura, MD, PhD, Shinshu University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2014

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

November 24, 2014

First Submitted That Met QC Criteria

November 28, 2014

First Posted (Estimate)

December 3, 2014

Study Record Updates

Last Update Posted (Actual)

September 21, 2021

Last Update Submitted That Met QC Criteria

September 20, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BP-ED study 2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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