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

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ClinicalTrials.gov Identifier: NCT02306187
Recruitment Status : Recruiting
First Posted : December 3, 2014
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Yukio Nakamura, 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.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Edirol 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Study Start Date : December 2014
Actual Primary Completion Date : December 2014
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Eldecalcitol




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02306187


Contacts
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Contact: Yukio Nakamura, MD, PhD +81-263-37-2659 yxn14@aol.jp

Locations
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Japan
Yukio Nakamura Recruiting
Matsumoto, Nagano, Japan, 3908621
Contact: Yukio Nakamura, MD, PhD    +81-263-37-2659    yxn14@aol.jp   
Principal Investigator: Yukio Nakamura, MD, PhD         
Sponsors and Collaborators
Shinshu University
Investigators
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Principal Investigator: Yukio Nakamura, MD, PhD Shinshu University School of Medicine

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Responsible Party: Yukio Nakamura, Assistant Professor, Shinshu University
ClinicalTrials.gov Identifier: NCT02306187     History of Changes
Other Study ID Numbers: BP-ED study 2014
First Posted: December 3, 2014    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

Keywords provided by Yukio Nakamura, Shinshu University:
The changes of bone mineral density and bone turnover markers

Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Diphosphonates
Eldecalcitol
Vitamin D
Bone Density Conservation Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances