The Effectiveness of Eldecalcitol in the Bisphosphonate Non-respondered-patients With Osteoporosis
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2014
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedFirst Posted
Study publicly available on registry
December 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedSeptember 21, 2021
September 1, 2021
8 years
November 24, 2014
September 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
At 4 months after the initial treatment
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
At 1 year after the initial treatment
Secondary Outcomes (2)
Number of Participants with bone mineral density as a Measure of bone quality
At 4 months after the initial treatment
Number of Participants with bone mineral density as a Measure of bone quality
At 1 year after the initial treatment
Study Arms (2)
Non-Alfacaocidol
EXPERIMENTALAhead 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
EXPERIMENTALAhead 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.
Interventions
Edirol 0.5 or 0.75ug once every day oral treatment for at least 1 year after initial visit.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of Osteoporosis
- Must be able to swallow tablets
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yukio Nakamura
Matsumoto, Nagano, 3908621, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yukio Nakamura, MD, PhD
Shinshu University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
November 24, 2014
First Posted
December 3, 2014
Study Start
December 1, 2014
Primary Completion
December 1, 2022
Study Completion
December 1, 2024
Last Updated
September 21, 2021
Record last verified: 2021-09