Involutional OsteoporosisPhase 3NCT00212628
Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan
A Phase 3 study testing Minodronic acid hydrate in people with Involutional Osteoporosis, run by Ono Pharmaceutical Co., Ltd. at 9 sites in Japan.
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 55 to 80 years, women only
- Conditions the study is for
- Involutional Osteoporosis
- What is being tested?
- Minodronic acid hydrate
- How many people
- 444 participants
- Where
- 9 sitesJapan
- Study dates
- Jun 2004to not given
- 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 55 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who was included in study ONO-5920-02 and completed the medication for two years
- Other inclusion criteria as specified in the study protocol
Who cannot join
- Patients judged to be unsuitable by safety evaluation as clinical trial subjects by the investigator
- Patients having secondary osteoporosis or another condition that presents low bone mass
- Other exclusion criteria as specified in the study protocol
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Japan9 sites
Chubu Region Facility
Chūbu
Chugoku Region Facility
Chugoku
Hokkaido Region Facility
Hokkaido
Hokuriku Region Facility
Hokuriku
Kanto Region Facility
Kanto
Kinki Region Facility
Kinki
Kyushu Region Facility
Kyushu
Shikoku Region Facility
Shikoku Region Facility
Tohoku Region Facility
Tōhoku
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
- Minodronic acid hydrate
- 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.
Minodronic acid hydrateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
New fragility vertebral fracture
Secondary outcomes (1)
New clinical fracture, biochemical markers of bone turnover, height, mean bone mineral density of the lumbar spine (L2-4 BMD), 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 startJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 444 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Sponsor
- Investigators
- Project Leader, Development Planning, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00212628
- Sponsor's protocol ID
- ONO-5920-04
- Status last verified
- Jun 2012
- First submitted
- 13 Sep 2005
- Last updated
- 14 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 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
- NCT00212628
- Acronym / sponsor ID
- ONO-5920-04
- Conditions
- Involutional Osteoporosis
- Keywords
- ONO-5920, osteoporosis, bisphosphonate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 444 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Inc
- Study start
- Jun 2004
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 55 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who was included in study ONO-5920-02 and completed the medication for two years
- Other inclusion criteria as specified in the study protocol
Key exclusion criteria (3 listed)
- Patients judged to be unsuitable by safety evaluation as clinical trial subjects by the investigator
- Patients having secondary osteoporosis or another condition that presents low bone mass
- 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 |
|---|---|---|
| Minodronic acid hydrate | Drug | – |
Primary outcome
New fragility vertebral fracture
1 secondary outcome
New clinical fracture, biochemical markers of bone turnover, height, mean bone mineral density of the lumbar spine (L2-4 BMD), 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 14 Jun 2012.
Related trials for Involutional Osteoporosis
Active, not recruitingPhase 4
Novel Precision Medicine Approach to Treatment of Osteoporosis Based on Bone Turnover
Age-Related Osteoporosis
Not yet recruitingPhase 1
A Clinical Study Evaluating the Dermal Safety of Soluble Denosumab Microneedle Patches
Osteoarthritis, Osteoarthritis (OA) of the Knee
RecruitingObservational study
Epidemiological Study of Osteoporosis in the Elderly Population of Shandong Province
Osteoporosis, Osteoporosis (Senile)
Active, not recruiting
Effects of FRAX+SARC-F Pre-screening on Preventing Fragility Fracture and Fall in Community-dwelling Older Adults
Age Related Osteoporosis, Fall
RecruitingObservational study
Genetic Regulators of Bone Health That Are Unique to Vertebral Bone
Age-Related Osteoporosis
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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Minodronic acid hydrate in people with Involutional Osteoporosis, run by Ono Pharmaceutical Co., Ltd. at 9 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 2 inclusion and 3 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 14 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 9 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 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?
New fragility vertebral fracture. 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 14 Jun 2012.