Postmenopausal OsteoporosisNCT01128257
A Study of Ibandronate [Bonviva/Boniva] and Alendronate in Female Patients With Post-Menopausal Osteoporosis
An observational study of Postmenopausal Osteoporosis, run by Hoffmann-La Roche at 1 site in Germany.
Trial summary
This observational study will assess the compliance and persistence of patients, real life efficacy and safety of intravenously quarterly administered 3 mg ibandronate [Bonviva/Boniva] in comparison to oral alendronate generics in female patients with post-menopausal osteoporosis. Read more about this study
- Who is it for?
- Ages 55 years and older, women only
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- alendronate and ibandronate [Bonviva/Boniva]
- How many people
- 6,054 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2010to Dec 2011
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female post-menopausal patients over the age of 55 years
Who may be able to join
- Adult patients, >/= 55 years of age
- Postmenopausal osteoporosis
- Patients who are in the opinion of the physician eligible to participate in this study
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Controllability and Real Life Efficacy of Bonviva 3 mg iv Quarterly vs. Oral Alendronate Generics
This observational study will assess the compliance and persistence of patients, real life efficacy and safety of intravenously quarterly administered 3 mg ibandronate [Bonviva/Boniva] in comparison to oral alendronate generics in female patients with post-menopausal osteoporosis. The anticipated time of assessment is 12 months. The target sample size is 5000-7000 patients.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- alendronate, 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.
alendronateDrug
As prescribed by physician
ibandronate [Bonviva/Boniva]Drug
As prescribed by physician
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Drug: ibandronate [Bonviva/Boniva] | |
| 2 | Not described Receives: Drug: alendronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of compliance and persistence of Bonviva therapy: Number of prescriptions, number of applied injections, number of taken oral medication, continuation and duration of treatment
Measured: 12 months
Secondary outcomes (8)
Pain intensity and reduction in use of analgesics
Measured: 12 months
Quality of life and patients satisfaction
Measured: 12 months
Degree of patient's mobility
Measured: 12 months
Incidence of new osteoporotic fractures
Measured: 12 months
Controllability and management of therapy by the physician
Measured: 12 months
Patient baseline characteristics
Measured: 12 months
User friendliness
Measured: 12 months
Safety: AEs and SAEs
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2011
- Study completionDec 2011
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,054 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
- NCT01128257
- Sponsor's protocol ID
- ML22927
- Status last verified
- Nov 2016
- First submitted
- 3 May 2010
- 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
- Controllability and Real Life Efficacy of Bonviva 3 mg iv Quarterly vs. Oral Alendronate Generics
- ClinicalTrials.gov ID
- NCT01128257
- Acronym / sponsor ID
- ML22927
- Conditions
- Postmenopausal Osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,054 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 21 May 2010 (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 observational study will assess the compliance and persistence of patients, real life efficacy and safety of intravenously quarterly administered 3 mg ibandronate [Bonviva/Boniva] in comparison to oral alendronate generics in female patients with post-menopausal osteoporosis. The anticipated time of assessment is 12 months. The target sample size is 5000-7000 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: ibandronate [Bonviva/Boniva] |
| 2 | – | Drug: alendronate |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female post-menopausal patients over the age of 55 years
Key inclusion criteria (3 listed)
- Adult patients, >/= 55 years of age
- Postmenopausal osteoporosis
- Patients who are in the opinion of the physician eligible to participate in this study
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| alendronateAs prescribed by physician | Drug | 2 |
| ibandronate [Bonviva/Boniva]As prescribed by physician | Drug | 1 |
Primary outcome
Assessment of compliance and persistence of Bonviva therapy: Number of prescriptions, number of applied injections, number of taken oral medication, continuation and duration of treatment
Time frame: 12 months
8 secondary outcomes
Pain intensity and reduction in use of analgesics
Time frame: 12 months
Quality of life and patients satisfaction
Time frame: 12 months
Degree of patient's mobility
Time frame: 12 months
Incidence of new osteoporotic fractures
Time frame: 12 months
Controllability and management of therapy by the physician
Time frame: 12 months
Patient baseline characteristics
Time frame: 12 months
User friendliness
Time frame: 12 months
Safety: AEs and SAEs
Time frame: 12 months
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postmenopausal Osteoporosis, run by Hoffmann-La Roche at 1 site in Germany.
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 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 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 1 site in Germany. 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?
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?
Assessment of compliance and persistence of Bonviva therapy: Number of prescriptions, number of applied injections, number of taken oral medication, continuation and duration of treatment (time frame: 12 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.