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

Sponsor
Shinshu University (Other)
Overall Status
Recruiting
CT.gov ID
NCT02306187
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
120
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effectiveness of Eldecalcitol in the Osteoporotic Patients Who Are Bisphosphonate Non-responders After Long-term Bisphosphonate Treatment
Actual Study Start Date :
Dec 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with bone turnover markers as a Measure of bone quality [At 4 months after the initial treatment]

      Bone formation and bone absorption markers will be evaluated at each time point

    2. 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

    1. Number of Participants with bone mineral density as a Measure of bone quality [At 4 months after the initial treatment]

      Bone mineral density will be evaluated at each time point

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Clinical diagnosis of Osteoporosis

    • Must be able to swallow tablets

    Exclusion Criteria:
    • N/A

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yukio Nakamura Matsumoto Nagano Japan 3908621

    Sponsors and Collaborators

    • Shinshu University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yukio Nakamura, Assistant Professor, Shinshu University
    ClinicalTrials.gov Identifier:
    NCT02306187
    Other Study ID Numbers:
    • BP-ED study 2014
    First Posted:
    Dec 3, 2014
    Last Update Posted:
    Sep 21, 2021
    Last Verified:
    Sep 1, 2021
    Keywords provided by Yukio Nakamura, Assistant Professor, Shinshu University
    The changes of bone mineral density and bone turnover markers
    Additional relevant MeSH terms:
    Osteoporosis
    Eldecalcitol

    Study Results

    No Results Posted as of Sep 21, 2021