Post Menopausal OsteoporosisPhase 4NCT00545090
ExBonAdAsia Study: A Study of Once Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.
A Phase 4 study testing ibandronate [Bonviva/Boniva] in people with Post Menopausal Osteoporosis, run by Hoffmann-La Roche at 17 sites in 5 countries.
Trial summary
This single arm study will continue drug safety surveillance, and assessment of adherence, in patients with postmenopausal osteoporosis who have received monthly oral Bonviva in ML19930, the BonAdAsia study. Read more about this study
- Who is it for?
- Ages Up to 85 years, 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
- 561 participants
- Where
- 17 sitesin 5 countries
- Study dates
- Aug 2006to Jun 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 Up to 85 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients responding to oral monthly Bonviva during the BonAdAsia study;
- willing to continue Bonviva treatment for a further 6 months.
Who cannot join
- none specified.
Trial locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
Taiwan7 sites
Study site
Changhua, 500
Study site
Taichung, 404
Study site
Taichung, 407
Study site
Tainan, 704
Study site
Taipei, 00112
Study site
Taipei, 100
Study site
Taoyuan, 333
Thailand4 sites
Study site
Bangkok, 10330
Study site
Bangkok, 10400
Study site
Chiang Mai, 50200
Study site
Khon Kaen, 40002
Indonesia3 sites
Study site
Jakarta, 10430
Study site
Makassar, 90174
Study site
Surabaya, 60286
About this study
Official title: An Open-label, Clinical Observation Extension Study to Assess Continuing Safety and Adherence in Patients With Postmenopausal Osteoporosis Receiving Monthly Oral Bonviva
This single arm study will continue drug safety surveillance, and assessment of adherence, in patients with postmenopausal osteoporosis who have received monthly oral Bonviva in ML19930, the BonAdAsia study. All patients completing 6 months in ML19930 will continue to receive Bonviva (150mg po, monthly) for an additional 6 months. 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 [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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: ibandronate [Bonviva/Boniva] |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAEs, AEs including fractures, adherence to treatment, clinical improvement, osteoporosis symptoms
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 startAug 2006
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 561 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
- NCT00545090
- Sponsor's protocol ID
- ML19937
- Status last verified
- Nov 2016
- First submitted
- 16 Oct 2007
- Last updated
- 10 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Clinical Observation Extension Study to Assess Continuing Safety and Adherence in Patients With Postmenopausal Osteoporosis Receiving Monthly Oral Bonviva
- ClinicalTrials.gov ID
- NCT00545090
- Acronym / sponsor ID
- ML19937
- Conditions
- Post Menopausal Osteoporosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 561 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 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 single arm study will continue drug safety surveillance, and assessment of adherence, in patients with postmenopausal osteoporosis who have received monthly oral Bonviva in ML19930, the BonAdAsia study. All patients completing 6 months in ML19930 will continue to receive Bonviva (150mg po, monthly) for an additional 6 months. 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 |
|---|---|---|
| 1 | Experimental | Drug: ibandronate [Bonviva/Boniva] |
Who may qualify
- Ages
- Up to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patients responding to oral monthly Bonviva during the BonAdAsia study;
- willing to continue Bonviva treatment for a further 6 months.
Key exclusion criteria (1 listed)
- none specified.
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 | Drug | 1 |
Primary outcome
SAEs, AEs including fractures, adherence to treatment, clinical improvement, osteoporosis symptoms
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 10 Nov 2016.
Related trials for Post Menopausal Osteoporosis
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Post Menopausal Osteoporosis
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The Comparison of Ibandronate and Zoledronic Acid After Denosumab Discontinuation
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Sequential Treatment With Romosozumab Followed by Denosumab vs. Zoledronic Acid for Gains in HIP BMD
Osteoporosis in Post-menopausal Women
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Sequential Therapies After Osteoanabolic Treatment
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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
17 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 Post Menopausal Osteoporosis, run by Hoffmann-La Roche at 17 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 2 inclusion and 1 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 10 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 17 sites in Taiwan, Thailand, Indonesia, Philippines, Hong Kong. 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?
SAEs, AEs including fractures, adherence to treatment, clinical improvement, osteoporosis symptoms (time frame: Throughout study). 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 10 Nov 2016.