OsteoporosisPhase 3NCT00493623
BONDIR Study: A Study of Intravenous Bonviva (Ibandronate) After Recent Vertebral Osteoporotic Fracture in Patients With Osteoporosis.
A Phase 3 study testing ibandronate [Bonviva/Boniva] in people with Osteoporosis, run by Hoffmann-La Roche at 27 sites in France.
Trial summary
This 2 arm study will assess the efficacy and safety of intravenous Bonviva in patients with osteoporosis experiencing pain after recent vertebral osteoporotic fracture. Patients will be randomized to receive either Bonviva (3mg i.v. bolus injection) or placebo. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Osteoporosis
- What is being tested?
- ibandronate [Bonviva/Boniva]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 27 sitesFrance
- Study dates
- Jun 2007to Dec 2009
- Phase
- Phase 3
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- postmenopausal women or men >30 years of age;
- osteoporosis;
- vertebral osteoporotic fracture in past 4 weeks;
- fracture-related pain requiring analgesic treatment.
Who cannot join
- non-menopausal women;
- current treatment with another bisphosphonate;
- current treatment with class III analgesics.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
France27 sites
Study site
Aix-en-Provence, 13616
Study site
Amiens, 80054
Study site
Angers, 49033
Study site
Bonneville, 74136
Study site
Bordeaux, 33076
Study site
Caen, 14033
Study site
Cannes, 06401
Study site
Clermont-Ferrand, 63003
Study site
Échirolles, 38434
Study site
Lille, 59037
Study site
Lomme, 59462
Study site
Marseille, 13285
Study site
Marseille, 13385
Study site
Montpellier, 34295
Study site
Mulhouse, 68070
Study site
Nantes, 44035
Study site
Nice, 06202
Study site
Orléans, 45000
Study site
Paris, 75181
Study site
Paris, 75475
Study site
Paris, 75571
Study site
Paris, 75651
Study site
Paris, 75674
Study site
Rennes, 35203
Study site
Rouen, 76031
Study site
Saint-Priest-en-Jarez, 42277
Study site
Toulouse, 31059
About this study
Official title: A Randomized, Double-blind Study of the Efficacy of Intravenous Bonviva in the Relief of Pain After Recent Vertebral Osteoporotic Fracture in Osteoporotic Patients.
This 2 arm study will assess the efficacy and safety of intravenous Bonviva in patients with osteoporosis experiencing pain after recent vertebral osteoporotic fracture. Patients will be randomized to receive either Bonviva (3mg i.v. bolus injection) or placebo. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.
- Conditions
- Osteoporosis
- Being tested
- Placebo, ibandronate [Bonviva/Boniva]
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo i.v. single dose
ibandronate [Bonviva/Boniva]Drug
3mg i.v. single dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: ibandronate [Bonviva/Boniva] |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of Bonviva therapy (>=20% diminution of pain intensity between day 0 and 7, with stabilization or diminution of concomitant analgesics between day 3 and 7).
Measured: Day 7
Secondary outcomes (5)
Percentage of patients with >=50% diminution of pain between day 0 and 7
Measured: Day 7
Pain control
Measured: Day 7 and 1 month
Analgesic medication
Measured: 1 month
Hospitalization
Measured: 1 month
AEs and laboratory parameters
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 posted28 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 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
- NCT00493623
- Sponsor's protocol ID
- ML19360
- Status last verified
- Mar 2016
- First submitted
- 27 Jun 2007
- Last updated
- 2 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Study of the Efficacy of Intravenous Bonviva in the Relief of Pain After Recent Vertebral Osteoporotic Fracture in Osteoporotic Patients.
- ClinicalTrials.gov ID
- NCT00493623
- Acronym / sponsor ID
- ML19360
- Conditions
- Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (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 2 arm study will assess the efficacy and safety of intravenous Bonviva in patients with osteoporosis experiencing pain after recent vertebral osteoporotic fracture. Patients will be randomized to receive either Bonviva (3mg i.v. bolus injection) or placebo. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 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 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- postmenopausal women or men >30 years of age;
- osteoporosis;
- vertebral osteoporotic fracture in past 4 weeks;
- fracture-related pain requiring analgesic treatment.
Key exclusion criteria (3 listed)
- non-menopausal women;
- current treatment with another bisphosphonate;
- current treatment with class III analgesics.
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 |
|---|---|---|
| PlaceboPlacebo i.v. single dose | Drug | 2 |
| ibandronate [Bonviva/Boniva]3mg i.v. single dose | Drug | 1 |
Primary outcome
Success of Bonviva therapy (>=20% diminution of pain intensity between day 0 and 7, with stabilization or diminution of concomitant analgesics between day 3 and 7).
Time frame: Day 7
5 secondary outcomes
Percentage of patients with >=50% diminution of pain between day 0 and 7
Time frame: Day 7
Pain control
Time frame: Day 7 and 1 month
Analgesic medication
Time frame: 1 month
Hospitalization
Time frame: 1 month
AEs and laboratory parameters
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 2 Mar 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
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ibandronate [Bonviva/Boniva] in people with Osteoporosis, run by Hoffmann-La Roche at 27 sites in France.
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 4 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: finished, as of the sponsor's last update on 2 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in France. 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. Some participants in this study may receive a placebo. 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?
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?
Success of Bonviva therapy (>=20% diminution of pain intensity between day 0 and 7, with stabilization or diminution of concomitant analgesics between day 3 and 7). (time frame: Day 7). 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 Mar 2016.