OsteoporosisPhase 3NCT00144456
A New Active Vitamin D, ED-71 for Osteoporosis
A Phase 3 study testing ED-71 and Alfacalcidol in people with Osteoporosis, run by Chugai Pharmaceutical.
Trial summary
A prospective, randomized, double-blind study to compare the effect of ED-71 with that of alfacalcidol on fracture incidence Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoporosis
- What is being tested?
- ED-71 and Alfacalcidol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,056 participants
- Where
- No sites listed yet
- Study dates
- Sep 2004to Oct 2008
- Phase
- Phase 3
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Osteoporotic patients who meet any of the following condition:
- with at least one fragility fracture,
- above 70 year-old with bone mineral density below 70% young adult mean,
- with bone mineral density below 60% young adult mean
- Women three years or more after menopause or men
Who cannot join
- Current disorders such as primary hyperparathyroidism, Cushing's syndrome,gonadal insufficiency, poorly controlled diabetes mellitus or other causes of secondary osteoporosis
- A history or suspicion of active urolithiasis at any time
- Use of bisphosphonates in the past 12 months
- Use of medications known to affect bone in the past 2 months
- Abnormal serum calcium, urinary calcium, serum creatinine or liver function tests
About this study
Official title: A Prospective, Randomized, Double-blind Study to Compare the Effect of ED-71 With That of Alfacalcidol on Fracture Incidence in Osteoporotic Patients
A prospective, randomized, double-blind study to compare the effect of ED-71 with that of alfacalcidol on fracture incidence
- Conditions
- Osteoporosis
- Being tested
- ED-71, Alfacalcidol, ED-71 placebo, Alfacalcidol placebo
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ED-71Drug
0.75μg/day(p.o.)for 144 weeks
AlfacalcidolDrug
1.0μg/day(p.o.)for 144 weeks
ED-71 placeboDrug
0 μg/day(p.o.)for 144 weeks
Alfacalcidol placeboDrug
0 μg/day(p.o.)for 144 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: ED-71; Drug: Alfacalcidol placebo |
| 2 | Active comparator | Not described Receives: Drug: Alfacalcidol; Drug: ED-71 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidences of vertebral fracture
Measured: throughout study
Secondary outcomes (1)
Changes of Lumbar Spine and total hip bone mineral density
Measured: throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionSep 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,056 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chugai Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Toshio Matsumoto, MD, Principal investigator, Department of Medicine and Bioregulatory Sciences, Universitof Tokushima Graduate School of Health Bioscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00144456
- Sponsor's protocol ID
- ED-209JP
- Status last verified
- Aug 2013
- First submitted
- 2 Sep 2005
- Last updated
- 9 Aug 2013
- Results posted
- No
Publications
Shiraki M, Saito H, Matsumoto T. Eldecalcitol normalizes bone turnover markers regardless of their pre-treatment levels. Curr Med Res Opin. 2012 Sep;28(9):1547-52. doi: 10.1185/03007995.2012.712506. Epub 2012 Aug 23.
PubMed 22794117Matsumoto T, Ito M, Hayashi Y, Hirota T, Tanigawara Y, Sone T, Fukunaga M, Shiraki M, Nakamura T. A new active vitamin D3 analog, eldecalcitol, prevents the risk of osteoporotic fractures--a randomized, active comparator, double-blind study. Bone. 2011 Oct;49(4):605-12. doi: 10.1016/j.bone.2011.07.011. Epub 2011 Jul 19.
PubMed 21784190
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blind Study to Compare the Effect of ED-71 With That of Alfacalcidol on Fracture Incidence in Osteoporotic Patients
- ClinicalTrials.gov ID
- NCT00144456
- Acronym / sponsor ID
- ED-209JP
- Conditions
- Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,056 participants (actual)
- Lead sponsor
- Chugai PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 5 Sep 2005 (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.
A prospective, randomized, double-blind study to compare the effect of ED-71 with that of alfacalcidol on fracture incidence
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ED-71, Drug: Alfacalcidol placebo |
| 2 | Active comparator | Drug: Alfacalcidol, Drug: ED-71 placebo |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Osteoporotic patients who meet any of the following condition:
- Women three years or more after menopause or men
Key exclusion criteria (5 listed)
- Current disorders such as primary hyperparathyroidism, Cushing's syndrome,gonadal insufficiency, poorly controlled diabetes mellitus or other causes of secondary osteoporosis
- A history or suspicion of active urolithiasis at any time
- Use of bisphosphonates in the past 12 months
- Use of medications known to affect bone in the past 2 months
- Abnormal serum calcium, urinary calcium, serum creatinine or liver function tests
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 |
|---|---|---|
| ED-710.75μg/day(p.o.)for 144 weeks | Drug | 1 |
| Alfacalcidol1.0μg/day(p.o.)for 144 weeks | Drug | 2 |
| ED-71 placebo0 μg/day(p.o.)for 144 weeks | Drug | 2 |
| Alfacalcidol placebo0 μg/day(p.o.)for 144 weeks | Drug | 1 |
Primary outcome
Incidences of vertebral fracture
Time frame: throughout study
1 secondary outcome
Changes of Lumbar Spine and total hip bone mineral density
Time frame: throughout study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2013.
- Derived from this study: PubMed 22794117Shiraki M, Saito H, Matsumoto T. Eldecalcitol normalizes bone turnover markers regardless of their pre-treatment levels. Curr Med Res Opin. 2012 Sep;28(9):1547-52. doi: 10.1185/03007995.2012.712506. Epub 2012 Aug 23.
- Derived from this study: PubMed 21784190Matsumoto T, Ito M, Hayashi Y, Hirota T, Tanigawara Y, Sone T, Fukunaga M, Shiraki M, Nakamura T. A new active vitamin D3 analog, eldecalcitol, prevents the risk of osteoporotic fractures--a randomized, active comparator, double-blind study. Bone. 2011 Oct;49(4):605-12. doi: 10.1016/j.bone.2011.07.011. Epub 2011 Jul 19.
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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.
Toshio Matsumoto, MD principal investigator
Department of Medicine and Bioregulatory Sciences, Universitof Tokushima Graduate School of Health Bioscience
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ED-71 and Alfacalcidol in people with Osteoporosis, run by Chugai Pharmaceutical.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 9 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidences of vertebral fracture (time frame: throughout study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00144456, which also lists 2 linked publications.
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 9 Aug 2013.