OsteoporosisPhase 3NCT00268632
IMPACT Study (Improving Measurements of Persistence on "ACtonel" Treatment)
A Phase 3 study testing risedronate in people with Osteoporosis, run by Sanofi.
Trial summary
The primary objective of this study is to assess the impact of physician's reinforcement using bone marker data on the subject's compliance (at least 50% drug taken) and persistence on treatment after one year in postmenopausal osteoporotic women. Read more about this study
- Who is it for?
- Ages 65 to 80 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- risedronate
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Aug 1999to Feb 2002
- 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 65 to 80 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Ambulatory women,
- Caucasian, Oriental or Multiracial
- not previously diagnosed for osteoporosis.
Who cannot join
- Females of black descent and for the US african american are excluded because of the very low incidence of postmenopausal osteoporosis
- and having used oral or parenteral glucocorticoids (>= 5 mg prednisone or equivalent per day) within 3 months of starting study drug or for more than one month within six months prior to study entry.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
About this study
Official title: A Multicenter Prospective Study to Assess the Impact of Physician's Reinforcement on the Subject's Compliance and Persistence on Treatment Using Feedback on Bone Markers in Previously Undiagnosed Postmenopausal Osteoporotic Women Treated With Risedronate.
The primary objective of this study is to assess the impact of physician's reinforcement using bone marker data on the subject's compliance (at least 50% drug taken) and persistence on treatment after one year in postmenopausal osteoporotic women.
- Conditions
- Osteoporosis
- Being tested
- risedronate
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risedronateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the impact of physician's reinforcement using bone marker data on the treatment adherence of women with PMO.
Measured: collected at week 10 and 22
Secondary outcomes (4)
to establish the profile of the unrecognized osteoporotic woman (PVD-, RF-) using a risk factor questionnaire for osteoporosis
Measured: During the study conduct
to assess the decrease of type I collagen breakdown products(urinary NTX and serum CTX)
Measured: after 10 and 22 weeks of treatment
To assess the change in BMD of both total hip and lumbar spine;
Measured: at week 52 compared to baseline
osteoporosis-related genotyping.
Measured: During the study conduct
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2005 (estimated)
- Study startAug 1999
- Primary completionFeb 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Procter and Gamble
- Investigators
- Lex van de Langerijt, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00268632
- Sponsor's protocol ID
- HMR4003B_4001
- Status last verified
- Jan 2011
- First submitted
- 21 Dec 2005
- Last updated
- 11 Jan 2011
- Results posted
- No
Publications
Delmas PD, Vrijens B, Eastell R, Roux C, Pols HA, Ringe JD, Grauer A, Cahall D, Watts NB; Improving Measurements of Persistence on Actonel Treatment (IMPACT) Investigators. Effect of monitoring bone turnover markers on persistence with risedronate treatment of postmenopausal osteoporosis. J Clin Endocrinol Metab. 2007 Apr;92(4):1296-304. doi: 10.1210/jc.2006-1526. Epub 2007 Jan 23.
PubMed 17244788
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Study to Assess the Impact of Physician's Reinforcement on the Subject's Compliance and Persistence on Treatment Using Feedback on Bone Markers in Previously Undiagnosed Postmenopausal Osteoporotic Women Treated With Risedronate.
- ClinicalTrials.gov ID
- NCT00268632
- Acronym / sponsor ID
- HMR4003B_4001
- Conditions
- Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Procter and Gamble
- Study start
- Aug 1999
- Primary completion
- Feb 2002 (actual)
- First posted
- 22 Dec 2005 (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 primary objective of this study is to assess the impact of physician's reinforcement using bone marker data on the subject's compliance (at least 50% drug taken) and persistence on treatment after one year in postmenopausal osteoporotic women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 65 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Ambulatory women,
- Caucasian, Oriental or Multiracial
- not previously diagnosed for osteoporosis.
Key exclusion criteria (3 listed)
- Females of black descent and for the US african american are excluded because of the very low incidence of postmenopausal osteoporosis
- and having used oral or parenteral glucocorticoids (>= 5 mg prednisone or equivalent per day) within 3 months of starting study drug or for more than one month within six months prior to study entry.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 | Drug | – |
Primary outcome
To assess the impact of physician's reinforcement using bone marker data on the treatment adherence of women with PMO.
Time frame: collected at week 10 and 22
4 secondary outcomes
to establish the profile of the unrecognized osteoporotic woman (PVD-, RF-) using a risk factor questionnaire for osteoporosis
Time frame: During the study conduct
to assess the decrease of type I collagen breakdown products(urinary NTX and serum CTX)
Time frame: after 10 and 22 weeks of treatment
To assess the change in BMD of both total hip and lumbar spine;
Time frame: at week 52 compared to baseline
osteoporosis-related genotyping.
Time frame: During the study conduct
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 11 Jan 2011.
- Results publication: PubMed 17244788Delmas PD, Vrijens B, Eastell R, Roux C, Pols HA, Ringe JD, Grauer A, Cahall D, Watts NB; Improving Measurements of Persistence on Actonel Treatment (IMPACT) Investigators. Effect of monitoring bone turnover markers on persistence with risedronate treatment of postmenopausal osteoporosis. J Clin Endocrinol Metab. 2007 Apr;92(4):1296-304. doi: 10.1210/jc.2006-1526. Epub 2007 Jan 23.
- Related InfoLink provided by the sponsor.
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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.
Lex van de Langerijt study director
Sanofi
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing risedronate in people with Osteoporosis, run by Sanofi.
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: finished, as of the sponsor's last update on 11 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
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 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?
To assess the impact of physician's reinforcement using bone marker data on the treatment adherence of women with PMO. (time frame: collected at week 10 and 22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00268632, which also lists 1 linked publication.
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 11 Jan 2011.