OsteoporosisPhase 2NCT00532337
Controlled Study of ONO-5334 in Postmenopausal Women With Osteopenia or Osteoporosis
A Phase 2 study testing ONO-5334 in people with Osteoporosis and Osteopenia, run by Ono Pharma USA Inc at 1 site in Netherlands.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of ONO-5334 in postmenopausal women with osteopenia or osteoporosis. Read more about this study
- Who is it for?
- Ages 55 to 75 years, women only
- Conditions the study is for
- Osteoporosis, Osteopenia
- What is being tested?
- ONO-5334
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 285 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2007to Jul 2010
- Phase
- Phase 2
- 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 55 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Osteoporosis defined as a value DXA BMD 2.5 SD or more below the young adult mean (T-score, ≤-2.5) at the lumbar spine (L1 to L4) or total hip, OR
- Osteoporosis defined as a value of DXA BMD more than 1 SD below the young adult mean, but less than 2.5 SD below this value (T-score <-1 and >2.5) at the lumbar spine (L1 to L4) or total hip.
Who cannot join
- Patients with a value of DXA BMD more that 3.5 SD below the young adult mean, (T-score <-3.5) at the lumbar spine (L1 to L4) or total hip.
- Osteoporosis patients (T-score ≤-2.5) who have any vertebral fragility fracture between T4 and L4 inclusive.
- Osteopenia patients (T-score <-1 and >-2.5) who have no vertebral fragility fractures between T4 and L4 inclusive, OR
- Osteopenia patients (T-score <-1 and >-2.5) who have two or more vertebral fragility fractures between T4 and L4 inclusive.
- Patients who have abnormalities of the lumbar spine or femoral neck or internal organs around them precluding the assessment of BMD.
- Patients who have secondary causes of osteoporosis or other disorders of bone and mineral metabolism.
- Other exclusion criteria as specified in the study protocol.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Andromed Noord Groningen
Damsterdiep 9, Provincie Groningen
About this study
Official title: A Multi-centre, Randomized, Double Blind, Parallel Group Study to Investigate Efficacy and Safety of ONO-5334 in Postmenopausal Women With Osteopenia or Osteoporosis
The purpose of this study is to evaluate the efficacy and safety of ONO-5334 in postmenopausal women with osteopenia or osteoporosis.
- Conditions
- Osteoporosis, Osteopenia
- Being tested
- ONO-5334
- Keywords
- ONO-5334, osteoporosis, osteopenia
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-5334Drug
Placebo - 24/mos.
ONO-5334Drug
100mg QD /24 months
ONO-5334Drug
50mg BID /24 mos.
ONO-5334Drug
300mg QD /24 mos.
ONO-5334Drug
Alendronate 70mg once weekly / 24 mos
| Study group | Role | What they receive |
|---|---|---|
| P | Placebo comparator | Not described Receives: Drug: ONO-5334 |
| E1 | Experimental | Not described Receives: Drug: ONO-5334 |
| E2 | Experimental | Not described Receives: Drug: ONO-5334 |
| E3 | Experimental | Not described Receives: Drug: ONO-5334 |
| A | Active comparator | Not described Receives: Drug: ONO-5334 |
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 (L 1-4 BMD)
Measured: 12 months
Secondary outcomes (1)
Bone mineral density at hip, Biochemical markers of bone turnover
Measured: during course of treatment of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionJul 2010
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 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharma USA Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tomohiro Kuwayama, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00532337
- Sponsor's protocol ID
- ONO-5334POE003
- Status last verified
- Jun 2012
- First submitted
- 19 Sep 2007
- Last updated
- 13 Jun 2012
- Results posted
- No
Publications
Eastell R, Nagase S, Small M, Boonen S, Spector T, Ohyama M, Kuwayama T, Deacon S. Effect of ONO-5334 on bone mineral density and biochemical markers of bone turnover in postmenopausal osteoporosis: 2-year results from the OCEAN study. J Bone Miner Res. 2014 Feb;29(2):458-66. doi: 10.1002/jbmr.2047.
PubMed 23873670
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Randomized, Double Blind, Parallel Group Study to Investigate Efficacy and Safety of ONO-5334 in Postmenopausal Women With Osteopenia or Osteoporosis
- ClinicalTrials.gov ID
- NCT00532337
- Acronym / sponsor ID
- ONO-5334POE003
- Conditions
- Osteoporosis, Osteopenia
- Keywords
- ONO-5334, osteoporosis, osteopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Ono Pharma USA IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jul 2010 (actual)
- First posted
- 20 Sep 2007 (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-5334 in postmenopausal women with osteopenia or osteoporosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| P | Placebo comparator | Drug: ONO-5334 |
| E1 | Experimental | Drug: ONO-5334 |
| E2 | Experimental | Drug: ONO-5334 |
| E3 | Experimental | Drug: ONO-5334 |
| A | Active comparator | Drug: ONO-5334 |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Osteoporosis defined as a value DXA BMD 2.5 SD or more below the young adult mean (T-score, ≤-2.5) at the lumbar spine (L1 to L4) or total hip, OR
- Osteoporosis defined as a value of DXA BMD more than 1 SD below the young adult mean, but less than 2.5 SD below this value (T-score <-1 and >2.5) at the lumbar spine (L1 to L4) or total hip.
Key exclusion criteria (7 listed)
- Patients with a value of DXA BMD more that 3.5 SD below the young adult mean, (T-score <-3.5) at the lumbar spine (L1 to L4) or total hip.
- Osteoporosis patients (T-score ≤-2.5) who have any vertebral fragility fracture between T4 and L4 inclusive.
- Osteopenia patients (T-score <-1 and >-2.5) who have no vertebral fragility fractures between T4 and L4 inclusive, OR
- Patients who have abnormalities of the lumbar spine or femoral neck or internal organs around them precluding the assessment of BMD.
- Patients who have secondary causes of osteoporosis or other disorders of bone and mineral metabolism.
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-5334Placebo - 24/mos. | Drug | P |
| ONO-5334100mg QD /24 months | Drug | E1 |
| ONO-533450mg BID /24 mos. | Drug | E2 |
| ONO-5334300mg QD /24 mos. | Drug | E3 |
| ONO-5334Alendronate 70mg once weekly / 24 mos | Drug | A |
Primary outcome
Mean bone mineral density of the lumbar spine (L 1-4 BMD)
Time frame: 12 months
1 secondary outcome
Bone mineral density at hip, Biochemical markers of bone turnover
Time frame: during course of treatment of 12 months
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 13 Jun 2012.
- Derived from this study: PubMed 23873670Eastell R, Nagase S, Small M, Boonen S, Spector T, Ohyama M, Kuwayama T, Deacon S. Effect of ONO-5334 on bone mineral density and biochemical markers of bone turnover in postmenopausal osteoporosis: 2-year results from the OCEAN study. J Bone Miner Res. 2014 Feb;29(2):458-66. doi: 10.1002/jbmr.2047.
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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.
Tomohiro Kuwayama study director
Ono Pharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ONO-5334 in people with Osteoporosis and Osteopenia, run by Ono Pharma USA Inc at 1 site in Netherlands.
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 7 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 13 Jun 2012. 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 Netherlands. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 (L 1-4 BMD) (time frame: 12 months). 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 NCT00532337, 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 13 Jun 2012; AzTrials last refreshed its copy on 7 Nov 2026.