Postmenopausal OsteoporosisPhase 4NCT00545909
BEATRIS Study: A Study of Adherence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis
A Phase 4 study testing ibandronate [Bonviva/Boniva] in people with Postmenopausal Osteoporosis, run by Hoffmann-La Roche at 57 sites in 5 countries.
Trial summary
This 2 arm study will assess the impact of Bone Marker Feedback (BMF), using blood sampling and communication of the results at 2 months, on adherence to monthly Bonviva (150mg po) in women with post-menopausal osteoporosis. Read more about this study
- Who is it for?
- Ages 55 to 85 years, women only
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- ibandronate [Bonviva/Boniva]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 585 participants
- Where
- 57 sitesin 5 countries
- Study dates
- Mar 2006to Aug 2008
- Phase
- Phase 4
- 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 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ambulatory post-menopausal women with osteoporosis;
- 55-85 years of age;
- eligible for bisphosphonate treatment;
- naive to bisphosphonate therapy, or lapsed users (last bisphosphonate intake > 6 months ago).
Who cannot join
- inability to stand or sit in an upright position for at least 60 minutes;
- inability to swallow a tablet whole;
- hypersensitivity to bisphosphonates;
- administration of any drug, or presence of active disease, known to influence bone metabolism;
- uncorrected hypocalcemia or other bone disturbances of bone and mineral metabolism;
- history of major upper gastrointestinal disease.
Trial locations and contacts
57 sites in 5 countries.
57 sites in 5 countries
Belgium34 sites
Study site
Aalst, 9300
Study site
Antwerp, 2018
Study site
Antwerp, 2020
Study site
Aye, 6900
Study site
Braine-l'Alleud, 1420
Study site
Bruges, 8000
Study site
Brussels, 1000
Study site
Brussels, 1020
Study site
Brussels, 1040
Study site
Brussels, 1180
Study site
Brussels, 1200
Study site
Charleroi, 6000
Study site
Dinant, 5500
Study site
Ekeren, 2180
Study site
Genk, 3600
Study site
Ghent, 9000
Study site
Godinne, 5530
Study site
Hasselt, 3500
Study site
Jambes, 5100
Study site
Knokke, 8300
Study site
Kortrijk, 8500
Study site
La Louvière, 7100
Study site
Liège, 4000
Study site
Liège, 4020
Study site
Mechelen, 2800
Study site
Merksem, 2170
Study site
Mons, 7000
Study site
Ostend, 8400
Study site
Roeselare, 8800
Study site
Sijsele, 8340
Study site
Tournai, 7500
Study site
Turnhout, 2300
Study site
Waremme, 4300
Study site
Wilrijk, 2610
Austria12 sites
Study site
Bregenz, 6900
Study site
Graz, 8036
Study site
Innsbruck, 6020
Study site
Linz, 4020
Study site
Salzburg, 5020
Study site
Vienna, 1021
Study site
Vienna, 1060
Study site
Vienna, 1100
Study site
Vienna, 1130
Study site
Vienna, 1150
Study site
Vienna, 1160
Study site
Vöcklabruck, 4840
Greece7 sites
Study site
Athens, 10682
Study site
Athens, 16673
Study site
Kifissia, 14561
Study site
Larissa, 41110
Study site
Thessaloniki, 54636
Study site
Thessaloniki, 55132
Study site
Thessaloniki, 56429
About this study
Official title: A Randomised, Open Label Study to Investigate the Impact of Bone Marker Feedback at 2 Months on Adherence to Monthly Oral Bonviva (Ibandronate) in Women With Post-menopausal Osteoporosis.
This 2 arm study will assess the impact of Bone Marker Feedback (BMF), using blood sampling and communication of the results at 2 months, on adherence to monthly Bonviva (150mg po) in women with post-menopausal osteoporosis. Patients will be randomized into either 1) a group which receives bone marker feedback or 2)a group which does not receive feedback on the results. The study will also assess patient satisfaction with treatment with once monthly Bonviva. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- ibandronate [Bonviva/Boniva]
- Medical subject headings
- Osteoporosis, Postmenopausal
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 6 months (+ feedback)
ibandronate [Bonviva/Boniva]Drug
150mg po monthly for 6 months (- feedback)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: ibandronate [Bonviva/Boniva] |
| 2 | Active comparator | Not described Receives: Drug: ibandronate [Bonviva/Boniva] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of percentage of patients with >=83% adherence to Bonviva in feedback vs no feedback group
Measured: 6 months
Secondary outcomes (2)
Patient satisfaction by OPSAT-Q and OPPS.
Measured: 6 months
Tolerability; SAEs.
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)
- Study startMar 2006
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal OsteoporosisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 585 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
- NCT00545909
- Sponsor's protocol ID
- ML19913
- Status last verified
- Nov 2016
- First submitted
- 16 Oct 2007
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Open Label Study to Investigate the Impact of Bone Marker Feedback at 2 Months on Adherence to Monthly Oral Bonviva (Ibandronate) in Women With Post-menopausal Osteoporosis.
- ClinicalTrials.gov ID
- NCT00545909
- Acronym / sponsor ID
- ML19913
- Conditions
- Postmenopausal Osteoporosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 585 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (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 assess the impact of Bone Marker Feedback (BMF), using blood sampling and communication of the results at 2 months, on adherence to monthly Bonviva (150mg po) in women with post-menopausal osteoporosis. Patients will be randomized into either 1) a group which receives bone marker feedback or 2)a group which does not receive feedback on the results. The study will also assess patient satisfaction with treatment with once monthly Bonviva. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ibandronate [Bonviva/Boniva] |
| 2 | Active comparator | Drug: ibandronate [Bonviva/Boniva] |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ambulatory post-menopausal women with osteoporosis;
- 55-85 years of age;
- eligible for bisphosphonate treatment;
- naive to bisphosphonate therapy, or lapsed users (last bisphosphonate intake > 6 months ago).
Key exclusion criteria (6 listed)
- inability to stand or sit in an upright position for at least 60 minutes;
- inability to swallow a tablet whole;
- hypersensitivity to bisphosphonates;
- administration of any drug, or presence of active disease, known to influence bone metabolism;
- uncorrected hypocalcemia or other bone disturbances 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 |
|---|---|---|
| ibandronate [Bonviva/Boniva]150mg po monthly for 6 months (+ feedback) | Drug | 1 |
| ibandronate [Bonviva/Boniva]150mg po monthly for 6 months (- feedback) | Drug | 2 |
Primary outcome
Comparison of percentage of patients with >=83% adherence to Bonviva in feedback vs no feedback group
Time frame: 6 months
2 secondary outcomes
Patient satisfaction by OPSAT-Q and OPPS.
Time frame: 6 months
Tolerability; SAEs.
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 2 Nov 2016.
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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
57 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ibandronate [Bonviva/Boniva] in people with Postmenopausal Osteoporosis, run by Hoffmann-La Roche at 57 sites in 5 countries.
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 6 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 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in Belgium, Austria, Greece, Ireland, Luxembourg. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Comparison of percentage of patients with >=83% adherence to Bonviva in feedback vs no feedback group (time frame: 6 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 Nov 2016.