Primary OsteoporosisPhase 3NCT00447915
Phase II/III Clinical Study of R484iv (Ibandronic Acid) for Primary Osteoporosis
A Phase 3 study testing ibandronic acid 0.5mg, 1.0mg ibandronic acid and 2.5mg RIS in people with Primary Osteoporosis, run by Chugai Pharmaceutical at 4 sites in Japan.
Trial summary
To evaluate the efficacy and safety of R484iv by intravenous intermittent administration to patients with primary osteoporosis in comparison with sodium risedronate hydrate (RIS) by oral administration every day. To evaluate also the dose response of R484iv. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Primary Osteoporosis
- What is being tested?
- ibandronic acid 0.5mg, 1.0mg ibandronic acid and 2.5mg RIS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,265 participants
- Where
- 4 sitesJapan
- Study dates
- Mar 2007to Dec 2011
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with fragile bone fracture
- Patients in whom either of study site analysis value of bone density of lumbar spine, proximal part of femur or neck of femur is less than 80% of young adult mean (YAM).
- Patients with 1 - 5 bone fractures in 4th thoracic spine (Th4) - 4th lumbar spine (L4)
- Ambulatory
Who cannot join
- Patients with disease lowering bone volume secondarily (secondary osteoporosis)
- Patients receiving at least one time of of oral bisphosphonate preparations within 6 months before the start of administration of the study drug
- Patient with disorder delaying the passage of food through esophagus
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Chubu/Kansai region
Chubu/Kansai
Chugoku/Kyusyu region
Chugoku/Kyusyu
Hokkaido/Tohoku region
Hokkaido/Tohoku
Kanto/Koshinetsu region
Kanto/Koshinetsu
About this study
Official title: Phase II/III Clinical Study of R484iv (Ibandronic Acid) for Primary Osteoporosis - Comparative Study With Sodium Risedronate Hydrate(RIS) With Vertebral Fracture as an Index -
To evaluate the efficacy and safety of R484iv by intravenous intermittent administration to patients with primary osteoporosis in comparison with sodium risedronate hydrate (RIS) by oral administration every day. To evaluate also the dose response of R484iv.
- Conditions
- Primary Osteoporosis
- Being tested
- ibandronic acid 0.5mg, RIS placebo, 1.0mg ibandronic acid, ibandronic acid placebo, 2.5mg RIS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ibandronic acid 0.5mgDrug
0.5mg(i.v.)/month for 35 months
RIS placeboDrug
0 mg(p.o.)/day for 36 months
1.0mg ibandronic acidDrug
1.0mg(i.v.)/month for 35 months
ibandronic acid placeboDrug
0mg(i.v.)/month for 35 months
2.5mg RISDrug
2.5 mg(p.o.)/day for 36 months
Calcium and Vitamine D3Dietary supplement
Calcium 305 mg and Vitamine D3 200IU(p.o.)/day for 36 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: ibandronic acid 0.5mg; Drug: RIS placebo; Dietary Supplement: Calcium and Vitamine D3 |
| 2 | Experimental | Not described Receives: Drug: RIS placebo; Drug: 1.0mg ibandronic acid; Dietary Supplement: Calcium and Vitamine D3 |
| 3 | Active comparator | Not described Receives: Drug: ibandronic acid placebo; Drug: 2.5mg RIS; Dietary Supplement: Calcium and Vitamine D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of vertebral fracture
Measured: 36 months
Secondary outcomes (3)
Change of bone density of lumbar spine and proximal part of femur from baseline
Measured: 36 months
Change of bone absorption marker from baseline
Measured: 36 months
Change of bone formation marker from baseline
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionAug 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary 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
- 1,265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chugai Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Toshitaka Nakamura, Study chair, University of Occupational and Environment Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00447915
- Sponsor's protocol ID
- JA19761
- Status last verified
- Jul 2012
- First submitted
- 14 Mar 2007
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II/III Clinical Study of R484iv (Ibandronic Acid) for Primary Osteoporosis - Comparative Study With Sodium Risedronate Hydrate(RIS) With Vertebral Fracture as an Index -
- ClinicalTrials.gov ID
- NCT00447915
- Acronym / sponsor ID
- JA19761
- Conditions
- Primary Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,265 participants (actual)
- Lead sponsor
- Chugai PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Aug 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 15 Mar 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.
To evaluate the efficacy and safety of R484iv by intravenous intermittent administration to patients with primary osteoporosis in comparison with sodium risedronate hydrate (RIS) by oral administration every day. To evaluate also the dose response of R484iv.
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 | Experimental | Drug: ibandronic acid 0.5mg, Drug: RIS placebo, Dietary Supplement: Calcium and Vitamine D3 |
| 2 | Experimental | Drug: RIS placebo, Drug: 1.0mg ibandronic acid, Dietary Supplement: Calcium and Vitamine D3 |
| 3 | Active comparator | Drug: ibandronic acid placebo, Drug: 2.5mg RIS, Dietary Supplement: Calcium and Vitamine D3 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with fragile bone fracture
- Patients in whom either of study site analysis value of bone density of lumbar spine, proximal part of femur or neck of femur is less than 80% of young adult mean (YAM).
- Patients with 1 - 5 bone fractures in 4th thoracic spine (Th4) - 4th lumbar spine (L4)
- Ambulatory
Key exclusion criteria (3 listed)
- Patients with disease lowering bone volume secondarily (secondary osteoporosis)
- Patients receiving at least one time of of oral bisphosphonate preparations within 6 months before the start of administration of the study drug
- Patient with disorder delaying the passage of food through esophagus
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 |
|---|---|---|
| ibandronic acid 0.5mg0.5mg(i.v.)/month for 35 months | Drug | 1 |
| RIS placebo0 mg(p.o.)/day for 36 months | Drug | 1, 2 |
| 1.0mg ibandronic acid1.0mg(i.v.)/month for 35 months | Drug | 2 |
| ibandronic acid placebo0mg(i.v.)/month for 35 months | Drug | 3 |
| 2.5mg RIS2.5 mg(p.o.)/day for 36 months | Drug | 3 |
| Calcium and Vitamine D3Calcium 305 mg and Vitamine D3 200IU(p.o.)/day for 36 months | Dietary supplement | 1, 2, 3 |
Primary outcome
Incidence of vertebral fracture
Time frame: 36 months
3 secondary outcomes
Change of bone density of lumbar spine and proximal part of femur from baseline
Time frame: 36 months
Change of bone absorption marker from baseline
Time frame: 36 months
Change of bone formation marker from baseline
Time frame: 36 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 2 Aug 2012.
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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.
Toshitaka Nakamura study chair
University of Occupational and Environment Health
4 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 ibandronic acid 0.5mg, 1.0mg ibandronic acid and 2.5mg RIS in people with Primary Osteoporosis, run by Chugai Pharmaceutical at 4 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 4 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 2 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Incidence of vertebral fracture (time frame: 36 months). 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 2 Aug 2012.