Involutional OsteoporosisPhase 3NCT00212719
Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan
A Phase 3 study testing ONO-5920 in people with Involutional Osteoporosis, run by Ono Pharmaceutical Co., Ltd..
Trial summary
The purpose of this study is to evaluate the efficacy and safety of ONO-5920 in patients with involutional osteoporosis. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Involutional Osteoporosis
- What is being tested?
- ONO-5920
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- May 2003to Apr 2006
- 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 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis in accordance with Criteria for the Diagnosis of Primary Osteoporosis.
- Other inclusion criteria as specified in the study protocol.
Who cannot join
- Patients having secondary osteoporosis or another condition that presents low bone mass.
- Patients having findings that affect measurement of lumbar spinal bone mineral density by DXA
- Patients that have been administered bisphosphonate derivatives.
- Other exclusion criteria as specified in the study protocol.
About this study
The purpose of this study is to evaluate the efficacy and safety of ONO-5920 in patients with involutional osteoporosis.
- Conditions
- Involutional Osteoporosis
- Being tested
- ONO-5920
- Keywords
- ONO-5920, osteoporosis, bisphosphonate
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-5920Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean bone mineral density of the lumbar spine (L2-4 BMD)
Secondary outcomes (1)
Bone mineral density at femur, fragility fractures, biochemical markers of bone turnover, lower back pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMay 2003
- Primary completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Involutional OsteoporosisStudies of the same condition, open and under way.
- More trials run by Ono Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Double blind
- Enrolment
- 250 participants
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Project Leader, ' Development Planning, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00212719
- Sponsor's protocol ID
- ONO-5920-03
- Status last verified
- Oct 2012
- First submitted
- 13 Sep 2005
- Last updated
- 11 Oct 2012
- Results posted
- No
Publications
Hagino H, Nishizawa Y, Sone T, Morii H, Taketani Y, Nakamura T, Itabashi A, Mizunuma H, Ohashi Y, Shiraki M, Minamide T, Matsumoto T. A double-blinded head-to-head trial of minodronate and alendronate in women with postmenopausal osteoporosis. Bone. 2009 Jun;44(6):1078-84. doi: 10.1016/j.bone.2009.02.016. Epub 2009 Mar 2.
PubMed 19264155
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan
- ClinicalTrials.gov ID
- NCT00212719
- Acronym / sponsor ID
- ONO-5920-03
- Conditions
- Involutional Osteoporosis
- Keywords
- ONO-5920, osteoporosis, bisphosphonate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2003
- Primary completion
- Apr 2006 (actual)
- First posted
- 21 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.
The purpose of this study is to evaluate the efficacy and safety of ONO-5920 in patients with involutional osteoporosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A diagnosis in accordance with Criteria for the Diagnosis of Primary Osteoporosis.
- Other inclusion criteria as specified in the study protocol.
Key exclusion criteria (4 listed)
- Patients having secondary osteoporosis or another condition that presents low bone mass.
- Patients having findings that affect measurement of lumbar spinal bone mineral density by DXA
- Patients that have been administered bisphosphonate derivatives.
- Other exclusion criteria as specified in the study protocol.
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 |
|---|---|---|
| ONO-5920 | Drug | – |
Primary outcome
Mean bone mineral density of the lumbar spine (L2-4 BMD)
1 secondary outcome
Bone mineral density at femur, fragility fractures, biochemical markers of bone turnover, lower back pain
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 11 Oct 2012.
- Derived from this study: PubMed 19264155Hagino H, Nishizawa Y, Sone T, Morii H, Taketani Y, Nakamura T, Itabashi A, Mizunuma H, Ohashi Y, Shiraki M, Minamide T, Matsumoto T. A double-blinded head-to-head trial of minodronate and alendronate in women with postmenopausal osteoporosis. Bone. 2009 Jun;44(6):1078-84. doi: 10.1016/j.bone.2009.02.016. Epub 2009 Mar 2.
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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.
Project Leader, ' Development Planning study director
Ono Pharmaceutical Co., Ltd.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ONO-5920 in people with Involutional Osteoporosis, run by Ono Pharmaceutical Co., Ltd..
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 4 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 11 Oct 2012. 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?
Mean bone mineral density of the lumbar spine (L2-4 BMD). 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 NCT00212719, which also lists 1 linked publication.
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 11 Oct 2012.