OsteoporosisPhase 1NCT02306187
The Effectiveness of Eldecalcitol in the Bisphosphonate Non-respondered-patients With Osteoporosis
A Phase 1 study testing Edirol in people with Osteoporosis, run by Shinshu University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Edirol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2014to Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of Osteoporosis
- Must be able to swallow tablets
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Yukio Nakamura
Matsumoto, Nagano, 3908621
Yukio Nakamura, MD, PhD, +81-263-37-2659, yxn14@aol.jp
Yukio Nakamura, MD, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoporosis
- Being tested
- Edirol
- Keywords
- The changes of bone mineral density and bone turnover markers
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EdirolDrug
Also called Eldecalcitol
Edirol 0.5 or 0.75ug once every day oral treatment for at least 1 year after initial visit.
| Study group | Role | What they receive |
|---|---|---|
| Non-Alfacaocidol | Experimental | 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. Receives: Drug: Edirol |
| Alfacalcidol | Experimental | 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. Receives: Drug: Edirol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: At 1 year after the initial treatment
Secondary outcomes (2)
Number of Participants with bone mineral density as a Measure of bone quality
Bone mineral density will be evaluated at each time point
Measured: At 4 months after the initial treatment
Number of Participants with bone mineral density as a Measure of bone quality
Bone mineral density will be evaluated at each time point
Measured: At 1 year after the initial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2022 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shinshu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yukio Nakamura, Shinshu University
- Investigators
- Yukio Nakamura, MD, PhD, Principal investigator, Shinshu University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306187
- Sponsor's protocol ID
- BP-ED study 2014
- Status last verified
- Sep 2021
- First submitted
- 24 Nov 2014
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Eldecalcitol in the Osteoporotic Patients Who Are Bisphosphonate Non-responders After Long-term Bisphosphonate Treatment
- ClinicalTrials.gov ID
- NCT02306187
- Acronym / sponsor ID
- BP-ED study 2014
- Conditions
- Osteoporosis
- Keywords
- The changes of bone mineral density and bone turnover markers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shinshu UniversityUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 3 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Alfacaocidol | Experimental | Drug: EdirolAhead 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 | Experimental | Drug: EdirolAhead 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Osteoporosis
- Must be able to swallow tablets
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EdirolAlso: EldecalcitolEdirol 0.5 or 0.75ug once every day oral treatment for at least 1 year after initial visit. | Drug | Alfacalcidol, Non-Alfacaocidol |
Primary outcome
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
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
2 secondary outcomes
Number of Participants with bone mineral density as a Measure of bone quality
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yukio Nakamura, MD, PhD principal investigator
Shinshu University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Edirol in people with Osteoporosis, run by Shinshu University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yukio Nakamura, MD, PhD (+81-263-37-2659, yxn14@aol.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with bone turnover markers as a Measure of bone quality (time frame: At 4 months after the initial treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.