Post-Menopausal OsteopeniaPhase 3NCT00545207
A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia.
A Phase 3 study testing ibandronate [Bonviva/Boniva] in people with Post-Menopausal Osteopenia, run by Hoffmann-La Roche at 4 sites in France.
Trial summary
This 2 arm study will compare the effect of oral Bonviva (150mg, monthly) and placebo on parameters of bone micro-architecture, assessed by CT scan, bone turnover and bone mineral density. Read more about this study
- Who is it for?
- Ages 55 to 75 years, women only
- Conditions the study is for
- Post-Menopausal Osteopenia
- What is being tested?
- ibandronate [Bonviva/Boniva]
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 4 sitesFrance
- Study dates
- Start not givento Sep 2010
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- post-menopausal women, aged 55-75 years;
- diagnosed osteopenia.
Who cannot join
- history of osteoporotic vertebral fracture;
- contraindication to ibandronate.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Study site
Lyon, 69437
Study site
Paris, 75475
Study site
Saint-Priest-en-Jarez, 42277
Study site
Toulouse, 31059
About this study
Official title: A Randomized, Double-blind Study of the Effect of Oral Monthly Bonviva on in Vivo Bone Micro-architecture Parameters in Post-menopausal Women With Osteopenia
This 2 arm study will compare the effect of oral Bonviva (150mg, monthly) and placebo on parameters of bone micro-architecture, assessed by CT scan, bone turnover and bone mineral density. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, and measurements will be taken at baseline, and at intervals over 2 years. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.
- Conditions
- Post-Menopausal Osteopenia
- Being tested
- ibandronate [Bonviva/Boniva], Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ibandronate [Bonviva/Boniva]Drug
150mg po monthly for 2 years
PlaceboDrug
po monthly for 2 years
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: ibandronate [Bonviva/Boniva] |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trabecular BV/TV at distal radius of non-dominant arm
Measured: 12 arms
Secondary outcomes (5)
Trabecular BV/TV at distal radius of non-dominant arm
Measured: 6 months and 2 years
Bone density, trabecular BV/TV at distal tibia
Measured: 6 months, 1 and 2 years
Serum CTX
Measured: Intervals throughout study
Lumbar hip and wrist BMD
Measured: 1 and 2 years
AEs and laboratory parameters
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2007 (estimated)
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Menopausal OsteopeniaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00545207
- Sponsor's protocol ID
- ML19357
- Status last verified
- Jan 2017
- First submitted
- 16 Oct 2007
- Last updated
- 26 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Study of the Effect of Oral Monthly Bonviva on in Vivo Bone Micro-architecture Parameters in Post-menopausal Women With Osteopenia
- ClinicalTrials.gov ID
- NCT00545207
- Acronym / sponsor ID
- ML19357
- Conditions
- Post-Menopausal Osteopenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 17 Oct 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.
This 2 arm study will compare the effect of oral Bonviva (150mg, monthly) and placebo on parameters of bone micro-architecture, assessed by CT scan, bone turnover and bone mineral density. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, and measurements will be taken at baseline, and at intervals over 2 years. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ibandronate [Bonviva/Boniva] |
| 2 | Placebo comparator | Drug: Placebo |
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)
- post-menopausal women, aged 55-75 years;
- diagnosed osteopenia.
Key exclusion criteria (2 listed)
- history of osteoporotic vertebral fracture;
- contraindication to ibandronate.
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 |
|---|---|---|
| ibandronate [Bonviva/Boniva]150mg po monthly for 2 years | Drug | 1 |
| Placebopo monthly for 2 years | Drug | 2 |
Primary outcome
Trabecular BV/TV at distal radius of non-dominant arm
Time frame: 12 arms
5 secondary outcomes
Trabecular BV/TV at distal radius of non-dominant arm
Time frame: 6 months and 2 years
Bone density, trabecular BV/TV at distal tibia
Time frame: 6 months, 1 and 2 years
Serum CTX
Time frame: Intervals throughout study
Lumbar hip and wrist BMD
Time frame: 1 and 2 years
AEs and laboratory parameters
Time frame: Throughout study
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 26 Jan 2017.
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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.
Clinical Trials study director
Hoffmann-La Roche
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 ibandronate [Bonviva/Boniva] in people with Post-Menopausal Osteopenia, run by Hoffmann-La Roche at 4 sites in France.
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 2 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 26 Jan 2017. 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 France. 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 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?
Trabecular BV/TV at distal radius of non-dominant arm (time frame: 12 arms). 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 26 Jan 2017.