Colles' FracturePhase 4SOLIDNCT00460733
SOLID-Effect of Risedronate Sodium at Distal Radius in Colle's Fracture.
A Phase 4 study testing Risedronate sodium and Calcium & Vitamine D3 in people with Colles' Fracture, run by Sanofi at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of risedronate sodium (Actonel®) after a wrist fracture in postmenopausal women. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Colles' Fracture
- What is being tested?
- Risedronate sodium and Calcium & Vitamine D3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2007to Sep 2011
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women with description of 2 or more years of Menopause;
- T-score <= -2.0 sd;
- Confirmed colles'fracture;
- Independent for the march (preserved ambulatorial ability);
Who cannot join
- Co-morbidities;
- Regular use of corticosteroids or other anti-resorptive drug in the last year;
- Use of drugs that can affect the calcium metabolism;
- Hypersensitivity to risedronate;
- Previous wrist or forearm fracture;
- Hypocalcemia;
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- Renal insufficiency;
- Rheumatic disease;
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Local (Brazil) Study, Multicenter, Opened, Comparative, Randomized, With Parallel Groups, Phase IV, in Post Menopausal Woman With Colles' Fracture of the Risedronate Sodium Usage in the Consolidation and in the Callus of the Colles'Fracture.
The purpose of this study is to evaluate the efficacy and safety of risedronate sodium (Actonel®) after a wrist fracture in postmenopausal women.
- Conditions
- Colles' Fracture
- Being tested
- Risedronate sodium, Calcium & Vitamine D3
- Medical subject headings
- Colles' Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risedronate sodiumDrug
Actonel® 35 mg (risedronate sodium) and 1000 mg of calcium and 400 UI of Vitamine D3
Calcium & Vitamine D3Drug
1000 mg of calcium and 400 UI of Vitamine D3
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Risedronate sodium |
| 2 | Active comparator | Not described Receives: Drug: Calcium & Vitamine D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mineral density of the 33% radius region and of the UD radius region
Measured: after 90 days of treatment
Secondary outcomes (3)
Body mineral density of the 33% radius region and of the UD radius region
Measured: after 180 days of treatment
Size of callus obtained through Rx of the fracture site.
Measured: from the beginning up to the end of the study
Safety: Adverse events occurrence.
Measured: from the inform consent signature up to the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colles' FractureStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Procter and Gamble
- Responsible party
- Sponsor
- Investigators
- Jaderson Lima, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460733
- Sponsor's protocol ID
- RISED_L_01930
- Acronym
- SOLID
- Status last verified
- Oct 2011
- First submitted
- 13 Apr 2007
- Last updated
- 4 Oct 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local (Brazil) Study, Multicenter, Opened, Comparative, Randomized, With Parallel Groups, Phase IV, in Post Menopausal Woman With Colles' Fracture of the Risedronate Sodium Usage in the Consolidation and in the Callus of the Colles'Fracture.
- ClinicalTrials.gov ID
- NCT00460733
- Acronym / sponsor ID
- SOLID / RISED_L_01930
- Conditions
- Colles' Fracture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Procter and Gamble
- Study start
- Mar 2007
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 16 Apr 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.
The purpose of this study is to evaluate the efficacy and safety of risedronate sodium (Actonel®) after a wrist fracture in postmenopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Risedronate sodium |
| 2 | Active comparator | Drug: Calcium & Vitamine D3 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Women with description of 2 or more years of Menopause;
- T-score <= -2.0 sd;
- Confirmed colles'fracture;
- Independent for the march (preserved ambulatorial ability);
Key exclusion criteria (9 listed)
- Co-morbidities;
- Regular use of corticosteroids or other anti-resorptive drug in the last year;
- Use of drugs that can affect the calcium metabolism;
- Hypersensitivity to risedronate;
- Previous wrist or forearm fracture;
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 |
|---|---|---|
| Risedronate sodiumActonel® 35 mg (risedronate sodium) and 1000 mg of calcium and 400 UI of Vitamine D3 | Drug | 1 |
| Calcium & Vitamine D31000 mg of calcium and 400 UI of Vitamine D3 | Drug | 2 |
Primary outcome
Body mineral density of the 33% radius region and of the UD radius region
Time frame: after 90 days of treatment
3 secondary outcomes
Body mineral density of the 33% radius region and of the UD radius region
Time frame: after 180 days of treatment
Size of callus obtained through Rx of the fracture site.
Time frame: from the beginning up to the end of the study
Safety: Adverse events occurrence.
Time frame: from the inform consent signature up to the end of the 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 4 Oct 2011.
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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.
Jaderson Lima study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Risedronate sodium and Calcium & Vitamine D3 in people with Colles' Fracture, run by Sanofi at 1 site in Brazil.
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 9 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 4 Oct 2011. 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 Brazil. 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?
Body mineral density of the 33% radius region and of the UD radius region (time frame: after 90 days of treatment). 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 4 Oct 2011.