Post-Menopausal OsteoporosisPhase 3NCT00545779
BONCURE Study: A Study of Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis on Bisphosphonate Therapy.
A Phase 3 study testing Ibandronate in people with Post-Menopausal Osteoporosis, run by Hoffmann-La Roche at 32 sites in 6 countries.
Trial summary
This single arm study will assess participant preference for monthly Bonviva, versus daily or weekly alendronate or risedronate, in the treatment of postmenopausal osteoporosis. Participants currently on a daily or weekly regimen of bisphosphonate therapy (alendronate or risedronate) will answer a questionnaire to… 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 677 participants
- Where
- 32 sitesin 6 countries
- Study dates
- Dec 2006to Oct 2008
- Phase
- Phase 3
- 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
- post-menopausal women;
- >=3 months daily or weekly alendronate or risedronate for treatment or prevention of post-menopausal osteoporosis.
Who cannot join
- inability to stand or sit in an upright position for at least 60 minutes;
- hypersensitivity to bisphosphonates;
- treatment with other drugs affecting bone metabolism;
- abnormalities of the oesophagus, which delay oesophageal emptying.
Trial locations and contacts
32 sites in 6 countries.
32 sites in 6 countries
Turkey (Türkiye)19 sites
Study site
Adana, 01330
Study site
Ankara, 06100
Study site
Ankara, 06550
Study site
Antalya, 07070
Study site
Aydin, 09100
Study site
Bursa, 16059
Study site
Denizli, 20020
Study site
Erzurum, 25240
Study site
Gaziantep, 27310
Study site
Istanbul, 34300
Study site
Istanbul, 34303
Study site
Istanbul, 35340
Study site
Istanbul, 81190
Study site
Izmir, 35100
Study site
Kayseri, 38039
Study site
Konya, 42080
Study site
Manisa, 45200
Study site
Samsun, 55139
Study site
Trabzon, 61080
Bosnia and Herzegovina4 sites
Study site
Banja Luka, 78000
Study site
Sarajevo, 71 000
Study site
Sarajevo, 71000
Study site
Tuzla, 75000
Croatia4 sites
Study site
Rijeka, 51000
Study site
Slavonski Brod, 35000
Study site
Split, 21000
Study site
Zagreb, 10000
Serbia3 sites
Study site
Belgrade, 11000
Study site
Niška Banja, 18205
Study site
Novi Sad, 21000
About this study
Official title: 'Open, Prospective, Multi-center, Two-part Study of Patient Preference With Monthly Ibandronate Therapy in Women With Postmenopausal Osteoporosis Switched From Once-daily or Once Weekly Alendronate or Risendronate - BONCURE (BONviva for Current Bisphosphonate Users - Regional European Trial)'
This single arm study will assess participant preference for monthly Bonviva, versus daily or weekly alendronate or risedronate, in the treatment of postmenopausal osteoporosis. Participants currently on a daily or weekly regimen of bisphosphonate therapy (alendronate or risedronate) will answer a questionnaire to identify participants who may benefit from a monthly Bonviva regimen. Eligible participants will then discontinue their present bisphosphonate treatment, and switch to monthly Bonviva 150mg per oral (po). At the beginning and end of Bonviva treatment, all participants will complete an Osteoporosis Patient Satisfaction Questionnaire. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
- Conditions
- Post-Menopausal Osteoporosis
- Being tested
- Ibandronate
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbandronateDrug
Also called [Bonviva/Boniva]
150 mg orally once monthly for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Ibandronate | Experimental | Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study. Receives: Drug: Ibandronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Current Daily or Weekly Bisphosphonate Users in Part A Who Answer 'Yes' to Any of the Questions in the Candidate Identification Questionnaire (CIQ)
The CIQ was completed in Part A by all the participants. The information from the CIQ was used to determine the percentage of current daily or weekly bisphosphonate users for whom monthly ibandronate represented a potentially more satisfactory therapeutic option.
In the CIQ participants were asked to answer either 'yes' or 'no' to the following 3 questions:
- I would prefer a monthly oral dosing schedule to my current (daily or weekly) dosing schedule.
- More than once per month, I have experienced stomach upset within 48 hours of taking my osteoporosis medication.
- Over the past 3 months, I have missed taking 3 or more doses of my current (daily or weekly) osteoporosis medication.
Measured: Visit 0 (less than or equal to [<=] Day -30)
Percentage of Participants Who Reported Preference for Monthly Ibandronate
Percentage of participants who reported preference for monthly ibandronate were reported.
Measured: Visit 0 (<= Day -30)
Percentage of Participants With Positive Change in Total Composite Satisfaction Score (CSS) at Month 6 in Part B by CIQ Fracture (Fr) Group
Participants with a positive change from their baseline CSS at Month 6 are considered those participants who are satisfied with once-monthly dosing of ibandronate after 6 months of use were reported. The CSS is scaled from 0 to 100 and is an average of the 4 domain scores of the Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q): Convenience (questions 1 to 6), Quality of Life (questions 7 and 8), Overall Satisfaction (questions 9 and 10) and Side Effects (questions 11 to 16). Higher scores indicating greater satisfaction.
Measured: Month 6
Secondary outcomes (7)
Percentage of Participants Eligible Current Daily or Weekly Bisphosphonate Users at Screening Who Elect to Enter Part B by CIQ
Measured: Visit 0 (<= Day -30)
Percentage of Participants Who Reported an Improved Satisfaction Score After 6 Months in Part B
Percentage of participants who report an improved satisfaction score after 6 months of monthly ibandronate therapy as compared to daily or weekly alendronate or risendronate at baseline based on responses to each individual question in the CIQ were reported. In the CIQ participants were asked to answer either 'yes' or 'no' to the following 3 questions:
- I would prefer a monthly oral dosing schedule to my current (daily or weekly) dosing schedule
- More than once per month, I have experienced stomach upset within 48 hours of taking my osteoporosis medication
- Over the past 3 months, I have missed taking 3 or more doses of my current (daily or weekly) osteoporosis medication
Measured: Month 6
Percentage of Participants Who Have Greater Than or Equal to (>=) 80% Compliance With 6 Monthly Doses of Ibandronate in Part B
Measured: Up to Month 6
Percentage of Participants Who Choose a Monthly Reminder to Take Ibandronate in Part B
Measured: Visit 0 (<= Day -30)
Percentage of Participants Who Reported an Improvement in the Frequency of Gastro-intestinal (GI) Symptoms Per Month in Part B
Measured: Baseline to Month 6
Percentage of Participants by Age and Activity Level Reporting High Satisfaction According to the Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) in Part B
Measured: Month 6
Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Domain Scores in Part B
The OPSAT-Q is a validated questionnaire designed to capture satisfaction with bisphosphonate treatment. It comprises four domains: convenience (questions 1-6), quality of life (questions 7 and 8), overall satisfaction (questions 9 and 10), and side effects (questions 11-16). Each domain (scale) ranges 0-100 scale. All items were scored such that higher scores represented greater satisfaction or less bother. Treatment satisfaction was measured with the OPSAT-Q composite satisfaction score (OPSAT-Q CSS), which was the average of the scores from the four domains of the OPSAT-Q converted to a 0-100-point scale, in which higher scores indicate greater satisfaction.
Measured: Baseline, Month 6
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 startDec 2006
- Primary completionOct 2008
- Study completionOct 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 677 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
- NCT00545779
- Sponsor's protocol ID
- ML20430
- Status last verified
- Sep 2016
- First submitted
- 16 Oct 2007
- Last updated
- 28 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'Open, Prospective, Multi-center, Two-part Study of Patient Preference With Monthly Ibandronate Therapy in Women With Postmenopausal Osteoporosis Switched From Once-daily or Once Weekly Alendronate or Risendronate - BONCURE (BONviva for Current Bisphosphonate Users - Regional European Trial)'
- ClinicalTrials.gov ID
- NCT00545779
- Acronym / sponsor ID
- ML20430
- Conditions
- Post-Menopausal Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 677 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 17 Oct 2007 (estimated)
- Results
- Posted 28 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single arm study will assess participant preference for monthly Bonviva, versus daily or weekly alendronate or risedronate, in the treatment of postmenopausal osteoporosis. Participants currently on a daily or weekly regimen of bisphosphonate therapy (alendronate or risedronate) will answer a questionnaire to identify participants who may benefit from a monthly Bonviva regimen. Eligible participants will then discontinue their present bisphosphonate treatment, and switch to monthly Bonviva 150mg per oral (po). At the beginning and end of Bonviva treatment, all participants will complete an Osteoporosis Patient Satisfaction Questionnaire. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ibandronate | Experimental | Drug: IbandronateParticipants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- post-menopausal women;
- >=3 months daily or weekly alendronate or risedronate for treatment or prevention of post-menopausal osteoporosis.
Key exclusion criteria (4 listed)
- inability to stand or sit in an upright position for at least 60 minutes;
- hypersensitivity to bisphosphonates;
- treatment with other drugs affecting bone metabolism;
- abnormalities of the oesophagus, which delay oesophageal emptying.
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 |
|---|---|---|
| IbandronateAlso: [Bonviva/Boniva]150 mg orally once monthly for 6 months | Drug | Ibandronate |
Primary outcome
Percentage of Participants Current Daily or Weekly Bisphosphonate Users in Part A Who Answer 'Yes' to Any of the Questions in the Candidate Identification Questionnaire (CIQ)
Time frame: Visit 0 (less than or equal to [<=] Day -30)
The CIQ was completed in Part A by all the participants. The information from the CIQ was used to determine the percentage of current daily or weekly bisphosphonate users for whom monthly ibandronate represented a potentially more satisfactory therapeutic option. In the CIQ participants were asked to answer either 'yes' or 'no' to the following 3 questions: 1. I would prefer a monthly oral dosing schedule to my current (daily or weekly) dosing schedule. 2. More than once per month, I have experienced stomach upset within 48 hours of taking my osteoporosis medication. 3. Over the past 3 months, I have missed taking 3 or more doses of my current (daily or weekly) osteoporosis medication.
Percentage of Participants Who Reported Preference for Monthly Ibandronate
Time frame: Visit 0 (<= Day -30)
Percentage of participants who reported preference for monthly ibandronate were reported.
Percentage of Participants With Positive Change in Total Composite Satisfaction Score (CSS) at Month 6 in Part B by CIQ Fracture (Fr) Group
Time frame: Month 6
Participants with a positive change from their baseline CSS at Month 6 are considered those participants who are satisfied with once-monthly dosing of ibandronate after 6 months of use were reported. The CSS is scaled from 0 to 100 and is an average of the 4 domain scores of the Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q): Convenience (questions 1 to 6), Quality of Life (questions 7 and 8), Overall Satisfaction (questions 9 and 10) and Side Effects (questions 11 to 16). Higher scores indicating greater satisfaction.
7 secondary outcomes
Percentage of Participants Eligible Current Daily or Weekly Bisphosphonate Users at Screening Who Elect to Enter Part B by CIQ
Time frame: Visit 0 (<= Day -30)
Percentage of Participants Who Reported an Improved Satisfaction Score After 6 Months in Part B
Time frame: Month 6
Percentage of Participants Who Have Greater Than or Equal to (>=) 80% Compliance With 6 Monthly Doses of Ibandronate in Part B
Time frame: Up to Month 6
Percentage of Participants Who Choose a Monthly Reminder to Take Ibandronate in Part B
Time frame: Visit 0 (<= Day -30)
Percentage of Participants Who Reported an Improvement in the Frequency of Gastro-intestinal (GI) Symptoms Per Month in Part B
Time frame: Baseline to Month 6
Percentage of Participants by Age and Activity Level Reporting High Satisfaction According to the Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) in Part B
Time frame: Month 6
Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Domain Scores in Part B
Time frame: Baseline, Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
32 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ibandronate in people with Post-Menopausal Osteoporosis, run by Hoffmann-La Roche at 32 sites in 6 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 4 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 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Turkey (Türkiye), Bosnia and Herzegovina, Croatia, Serbia, Albania and 1 more country. 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?
Yes. Results are posted in the registry (first posted 28 Oct 2016). 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?
Percentage of Participants Current Daily or Weekly Bisphosphonate Users in Part A Who Answer 'Yes' to Any of the Questions in the Candidate Identification Questionnaire (CIQ) (time frame: Visit 0 (less than or equal to [<=] Day -30)). The study lists 3 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 28 Oct 2016.