OsteoporosisPhase 2/3NCT00794443
ONO-5920/YM529 Confirmatory Study in Involutional Osteoporosis Patients
A Phase 2/3 study testing YM529 / ONO-5920 in people with Osteoporosis and Bone Loss, Age-Related, run by Astellas Pharma Inc at 5 sites in Japan.
Trial summary
This is a multi-center double-blind parallel-group study in involutional osteoporosis patients to compare the efficacy and safety of monthly oral intermittent formulation ONO-5920/YM529 with its daily formulation. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Osteoporosis, Bone Loss, Age-Related
- What is being tested?
- YM529 / ONO-5920
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 692 participants
- Where
- 5 sitesJapan
- Study dates
- Nov 2008to Apr 2010
- Phase
- Phase 2/3
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients whose bone mineral density is <70% of Young Adult Mean (YAM), or <80% of YAM who have fragile fracture history
- Patients can walk on his/her own
- Written informed consent has been obtained from the patient.
Who cannot join
- Sequential osteoporosis patients or patients with other disorders showing low bone mass
- Patients with the findings that influence measurement of lumbar vertebral bone mineral density by the DXA method
- Patients who are unable to keep raising or standing for ≥30 min
- Patients with peptic ulcer
- Patients who have experienced anamnesis or gastrectomy (total extraction)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Japan5 sites
Study site
Hokkaido
Study site
Kansai
Study site
Kantou
Study site
Kyusyu
Study site
Shikoku
About this study
Official title: A Multi-center Double-blind Parallel-group Comparison Study in Involutional Osteoporosis Patients to Examine the Efficacy and Safety of ONO-5920/YM529 Monthly Intermittent Formulation With Its Daily Formulation.
This is a multi-center double-blind parallel-group study in involutional osteoporosis patients to compare the efficacy and safety of monthly oral intermittent formulation ONO-5920/YM529 with its daily formulation.
- Conditions
- Osteoporosis, Bone Loss, Age-Related
- Being tested
- YM529 / ONO-5920
- Keywords
- ONO-5920, YM529, Bone mineral density, Minodronic acid
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YM529 / ONO-5920Drug
Also called YM529, ONO-5920, Minodronic acid
Oral
| Study group | Role | What they receive |
|---|---|---|
| 1. Monthly - Dose 1 | Experimental | Monthly intermittent administration, dose 1 Receives: Drug: YM529 / ONO-5920 |
| 2. Monthly - Dose 2 | Experimental | Monthly intermittent administration, dose 2 Receives: Drug: YM529 / ONO-5920 |
| 3. Daily | Active comparator | Daily administration Receives: Drug: YM529 / ONO-5920 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent changes in the lumbar vertebral bone mineral density (L2-4BMD) by the DXA method
Measured: At the final evaluation point
Secondary outcomes (4)
Time-course changes in the percent change of bone metabolism markers
Measured: Through the treatment period
Time-course changes in the total femoral bone mineral density by the DXA method
Measured: Through the treatment period
Assessment of adverse events, lab test values
Measured: Through the treatment period
Frequency of fracture
Measured: At the final evaluation point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionApr 2010
- Study completionApr 2010
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 692 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Toshiomi Minamide, Study director, Ono Pharmaceutical Co., Ltd.Central Contact, Study chair, Clinical Development Administration Dept., Astellas Pharma Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00794443
- Sponsor's protocol ID
- 529-CL-028
- Other IDs
- ONO-5920-05
- Status last verified
- Apr 2015
- First submitted
- 18 Nov 2008
- Last updated
- 4 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Double-blind Parallel-group Comparison Study in Involutional Osteoporosis Patients to Examine the Efficacy and Safety of ONO-5920/YM529 Monthly Intermittent Formulation With Its Daily Formulation.
- ClinicalTrials.gov ID
- NCT00794443
- Acronym / sponsor ID
- 529-CL-028
- Conditions
- Osteoporosis, Bone Loss, Age-Related
- Keywords
- ONO-5920, YM529, Bone mineral density, Minodronic acid
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 692 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Study start
- Nov 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 20 Nov 2008 (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.
This is a multi-center double-blind parallel-group study in involutional osteoporosis patients to compare the efficacy and safety of monthly oral intermittent formulation ONO-5920/YM529 with its daily formulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1. Monthly - Dose 1 | Experimental | Drug: YM529 / ONO-5920Monthly intermittent administration, dose 1 |
| 2. Monthly - Dose 2 | Experimental | Drug: YM529 / ONO-5920Monthly intermittent administration, dose 2 |
| 3. Daily | Active comparator | Drug: YM529 / ONO-5920Daily administration |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients whose bone mineral density is <70% of Young Adult Mean (YAM), or <80% of YAM who have fragile fracture history
- Patients can walk on his/her own
- Written informed consent has been obtained from the patient.
Key exclusion criteria (5 listed)
- Sequential osteoporosis patients or patients with other disorders showing low bone mass
- Patients with the findings that influence measurement of lumbar vertebral bone mineral density by the DXA method
- Patients who are unable to keep raising or standing for ≥30 min
- Patients with peptic ulcer
- Patients who have experienced anamnesis or gastrectomy (total extraction)
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 |
|---|---|---|
| YM529 / ONO-5920Also: YM529, ONO-5920, Minodronic acidOral | Drug | 1. Monthly - Dose 1, 2. Monthly - Dose 2, 3. Daily |
Primary outcome
Percent changes in the lumbar vertebral bone mineral density (L2-4BMD) by the DXA method
Time frame: At the final evaluation point
4 secondary outcomes
Time-course changes in the percent change of bone metabolism markers
Time frame: Through the treatment period
Time-course changes in the total femoral bone mineral density by the DXA method
Time frame: Through the treatment period
Assessment of adverse events, lab test values
Time frame: Through the treatment period
Frequency of fracture
Time frame: At the final evaluation point
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 4 May 2015.
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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.
Toshiomi Minamide study director
Ono Pharmaceutical Co., Ltd.
Central Contact study chair
Clinical Development Administration Dept., Astellas Pharma Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing YM529 / ONO-5920 in people with Osteoporosis and Bone Loss, Age-Related, run by Astellas Pharma Inc at 5 sites 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 3 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 4 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Percent changes in the lumbar vertebral bone mineral density (L2-4BMD) by the DXA method (time frame: At the final evaluation point). 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 4 May 2015.