Postmenopausal OsteoporosisNCT00493532
A Study of Quarterly Intravenous Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.
A study testing ibandronate [Bonviva/Boniva] in people with Postmenopausal Osteoporosis, run by Hoffmann-La Roche at 14 sites in Taiwan.
Trial summary
This single arm study will assess the efficacy and safety of quarterly intravenous Bonviva in women with post-menopausal osteoporosis. All patients will receive Bonviva 3mg i.v. every 3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals. Read more about this study
- Who is it for?
- Ages Up to 80 years, women only
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- ibandronate [Bonviva/Boniva]
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 14 sitesTaiwan
- Study dates
- Jun 2007to Dec 2010
- Phase
- Expanded access
- 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 80 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- post-menopausal women with osteoporosis;
- <=80 years of age;
- naive to oral bisphosphonates, or have discontinued daily and/or weekly bisphosphonate treatment for >1 year.
Who cannot join
- metabolic bone disease other than post-menopausal osteoporosis;
- treatment with other drugs affecting bone metabolism within last 6 months;
- previous or current malignant disease (except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer).
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Taiwan14 sites
Study site
Chai Yi, 613
Study site
Changhua, 500
Study site
Kaohsiung City, 00833
Study site
Kaohsiung City, 804
Study site
Kaohsiung City, 807
Study site
Taichung, 402
Study site
Taichung, 404
Study site
Taichung, 40705
Study site
Tainan, 704
Study site
Tainan, 710
Study site
Taipei, 00112
Study site
Taipei, 100
Study site
Taipei, 886
Study site
Taoyuan, 333
About this study
Official title: An Open Label Study to Evaluate the Effect on Bone Mineral Density, and the Safety, of Quarterly Intravenous Bonviva in Patients With Post-menopausal Osteoporosis.
This single arm study will assess the efficacy and safety of quarterly intravenous Bonviva in women with post-menopausal osteoporosis. All patients will receive Bonviva 3mg i.v. every 3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 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
3mg iv every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionDec 2010
- Study completionDec 2010
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
- Expanded access
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
- NCT00493532
- Sponsor's protocol ID
- ML20882
- Status last verified
- Nov 2016
- First submitted
- 27 Jun 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
- An Open Label Study to Evaluate the Effect on Bone Mineral Density, and the Safety, of Quarterly Intravenous Bonviva in Patients With Post-menopausal Osteoporosis.
- ClinicalTrials.gov ID
- NCT00493532
- Acronym / sponsor ID
- ML20882
- Conditions
- Postmenopausal Osteoporosis
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 28 Jun 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 assess the efficacy and safety of quarterly intravenous Bonviva in women with post-menopausal osteoporosis. All patients will receive Bonviva 3mg i.v. every 3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.
Study design
Who may qualify
- Ages
- Up to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- post-menopausal women with osteoporosis;
- <=80 years of age;
- naive to oral bisphosphonates, or have discontinued daily and/or weekly bisphosphonate treatment for >1 year.
Key exclusion criteria (3 listed)
- metabolic bone disease other than post-menopausal osteoporosis;
- treatment with other drugs affecting bone metabolism within last 6 months;
- previous or current malignant disease (except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer).
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]3mg iv every 3 months | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
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
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ibandronate [Bonviva/Boniva] in people with Postmenopausal Osteoporosis, run by Hoffmann-La Roche at 14 sites in Taiwan.
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 3 inclusion and 3 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: status not confirmed, 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 14 sites in Taiwan. 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.
Are results available for this study?
Results are not available in the source record.
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.
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.