Post-Menopausal OsteoporosisPhase 4NCT00081653
A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva
A Phase 4 study testing ibandronate [Bonviva/Boniva] in people with Post-Menopausal Osteoporosis, run by Hoffmann-La Roche at 31 sites in 14 countries.
Trial summary
This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Post-Menopausal Osteoporosis
- What is being tested?
- ibandronate [Bonviva/Boniva]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 719 participants
- Where
- 31 sitesin 14 countries
- Study dates
- May 2004to May 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- successful completion of Bonviva study BM16549, with at least 75% compliance;
- ambulatory.
Who cannot join
- malignant disease diagnosed within the previous 12 years (except basal cell cancer that has been successfully removed);
- breast cancer diagnosed within the previous 22 years.
Trial locations and contacts
31 sites in 14 countries.
31 sites in 14 countries
United States5 sites
Study site
Lakewood, Colorado, 80260
Study site
Livingston, New Jersey, 07039
Study site
Loma Linda, California, 92357
Study site
Omaha, Nebraska, 68131
Study site
Portland, Oregon, 97213
Hungary5 sites
Study site
Balatonfüred, 8230
Study site
Budapest, 1036
Study site
Budapest, 1083
Study site
Kiskunhalas, 6400
Study site
Zalaegerszeg, 8900
Denmark3 sites
Study site
Aalborg, 9000
Study site
Ballerup Municipality, 2750
Study site
Vejle, 7100
About this study
Official title: Double-blind, Partially Randomized, Parallel Group, Multicenter Study to Assess the Efficacy and Safety of 100 mg and 150 mg Monthly Oral Ibandronate in Women With Postmenopausal Osteoporosis Having Completed the Phase III Oral Ibandronate Trial BM16549
This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.
- Conditions
- Post-Menopausal 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 3 years
ibandronate [Bonviva/Boniva]Drug
100mg po monthly for 3 years
| 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.
Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD
Absolute change from Baseline in mean BMD of the lumbar spine (L2 - L4) measured as grams per square centimeter (g/cm^2). This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 [NCT00081653]).
Measured: Baseline and Months 12, 24 and 36
Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD)
BMD was measured by a single dual-energy X-ray absorptiometry (DXA) scan of the lumbar spine (BMD of at least 2 vertebrae [L2-L4] that were not fractured and not affected by osteoarthritis to such a degree that BMD measurement would be compromised) at the time of enrollment and at Months 12, 24 and 36. This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 [NCT00081653]).
Measured: Baseline and Months 12, 24 and 36
Secondary outcomes (4)
Absolute Change From Baseline in Mean Total Hip BMD
BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones).
Measured: Baseline and 12, 24 and 36 months
Relative Percent Change From Baseline in Mean Total Hip BMD
BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones).
Measured: Baseline, 12, 24 and 36 months
Absolute Change From Baseline of Trough Serum CTX
CTX is a measure of bone resorption and is measured as ng/mL. Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values.
Measured: Baseline, 6, 12, 24 and 36 months
Relative Percent Change From Baseline of Trough Serum CTX
CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL). Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values.
Measured: Baseline, 6,12, 24 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2004 (estimated)
- Study startMay 2004
- Primary completionNov 2007
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-Menopausal 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 719 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
- NCT00081653
- Sponsor's protocol ID
- MA17903
- Status last verified
- Jul 2017
- First submitted
- 19 Apr 2004
- Last updated
- 14 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Partially Randomized, Parallel Group, Multicenter Study to Assess the Efficacy and Safety of 100 mg and 150 mg Monthly Oral Ibandronate in Women With Postmenopausal Osteoporosis Having Completed the Phase III Oral Ibandronate Trial BM16549
- ClinicalTrials.gov ID
- NCT00081653
- Acronym / sponsor ID
- MA17903
- Conditions
- Post-Menopausal Osteoporosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 719 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 21 Apr 2004 (estimated)
- Results
- Posted 21 Jul 2009
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 long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 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 | Active comparator | Drug: ibandronate [Bonviva/Boniva] |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- successful completion of Bonviva study BM16549, with at least 75% compliance;
- ambulatory.
Key exclusion criteria (2 listed)
- malignant disease diagnosed within the previous 12 years (except basal cell cancer that has been successfully removed);
- breast cancer diagnosed within the previous 22 years.
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 3 years | Drug | 1 |
| ibandronate [Bonviva/Boniva]100mg po monthly for 3 years | Drug | 2 |
Primary outcome
Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD
Time frame: Baseline and Months 12, 24 and 36
Absolute change from Baseline in mean BMD of the lumbar spine (L2 - L4) measured as grams per square centimeter (g/cm^2). This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 [NCT00081653]).
Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD)
Time frame: Baseline and Months 12, 24 and 36
BMD was measured by a single dual-energy X-ray absorptiometry (DXA) scan of the lumbar spine (BMD of at least 2 vertebrae [L2-L4] that were not fractured and not affected by osteoarthritis to such a degree that BMD measurement would be compromised) at the time of enrollment and at Months 12, 24 and 36. This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 [NCT00081653]).
4 secondary outcomes
Absolute Change From Baseline in Mean Total Hip BMD
Time frame: Baseline and 12, 24 and 36 months
Relative Percent Change From Baseline in Mean Total Hip BMD
Time frame: Baseline, 12, 24 and 36 months
Absolute Change From Baseline of Trough Serum CTX
Time frame: Baseline, 6, 12, 24 and 36 months
Relative Percent Change From Baseline of Trough Serum CTX
Time frame: Baseline, 6,12, 24 and 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Post-Menopausal Osteoporosis
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Sequential Treatment With Romosozumab Followed by Denosumab vs. Zoledronic Acid for Gains in HIP BMD
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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
31 sites in 14 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 Post-Menopausal Osteoporosis, run by Hoffmann-La Roche at 31 sites in 14 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 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 14 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Hungary, Denmark, Belgium, Czechia and 9 more countries. 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?
Yes. Results are posted in the registry (first posted 21 Jul 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD (time frame: Baseline and Months 12, 24 and 36). The study lists 2 primary outcomes in all. 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 Jul 2017.