Osteoporosis, PostmenopausalPhase 4NCT00549965
Satisfaction and Compliance of Risedronate in PMO
A Phase 4 study testing Risedronate Sodium in people with Osteoporosis, Postmenopausal, run by Sanofi at 1 site in South Korea.
Trial summary
Compare subject satisfaction of once a week dosing of 35 mg Risedronate to once daily dosing of 5 mg Risedronate in postmenopausal osteoporotic women. Secondary objectives are to measure compliance (50 % drug taken), and persistence. Read more about this study
- Who is it for?
- Ages 55 to 80 years, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- Risedronate Sodium
- How many people
- 202 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2003to not given
- 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 55 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Five (5) years or greater postmenopausal who present with a diagnosis of postmenopausal osteoporosis based on standard clinical practice criteria.
- Subjects must discontinue bisphosphonates, calcitonin, fluoride, glucocorticoids (> than or = to 5 mg prednisone or equivalent per day) and hormone replacement therapy including estrogen-related compounds at least 6 months prior to randomization. During the study, these drugs are not permitted other than the study medication, Risedronate.
- Other concomitant medications should be kept to a minimum, but if the drugs are considered necessary for the subject's welfare and are unlikely to interfere with study medication they may be given at the discretion of the Investigator.
Who cannot join
- Had a history of cancer within the past 5 years. Relatively benign skin malignancies, such as basal cell carcinoma or squamous cell carcinoma, are not an exclusion if the subject has been in remission for at least 6 months prior to enrollment.
- Diagnosis of hypocalcemia, hyperparathyroidism, and hyperthyroidism.
- History of alcohol and/or drug abuse.
- Subjects will be excluded for active gastrointestinal disease that may interfere with absorption or with ability to swallow an oral medication.
- Subjects will also be excluded for serious concurrent illness that would interfere with their ability to participate in the trial.
- Excluded medications: bisphosphonates, calcitonin or fluoride or hormone replacement therapy within the last 6 months.
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- Known hypersensitivity to bisphosphonates and/or excipients.
- Abnormal laboratory parameters, which are clinically relevant according to the Investigator (including renal insufficiency; creatinine clearance < 30 mL/min)
- 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: A Multicenter, Prospective, Randomized, 2-Way Crossover, Open-Label Phase IV Study in Postmenopausal Women With Osteoporosis Examining Subject Satisfaction and Compliance When Actonel(Rosedronate) is Administered 35mg Once a Week or 5mg
Compare subject satisfaction of once a week dosing of 35 mg Risedronate to once daily dosing of 5 mg Risedronate in postmenopausal osteoporotic women. Secondary objectives are to measure compliance (50 % drug taken), and persistence.
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- Risedronate Sodium
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risedronate SodiumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of subject satisfaction of once a week 35 mg Risedronate and once daily 5 mg Risedronate.
Measured: A subject-administered questionnaire at 12 and 24 weeks will assess satisfaction.
Secondary outcomes (1)
The subjects' compliance and persistence on treatment. Compliance as defined by more than 50% of the drug taken (by tablet count) during each Risedronate treatment period.
Measured: Persistence at week 12 and 24 will be defined as continuing Risedronate treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2007 (estimated)
- Study startOct 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, PostmenopausalStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Choe Seong Choon, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00549965
- Sponsor's protocol ID
- HMR4003B_4035
- Status last verified
- Oct 2007
- First submitted
- 24 Oct 2007
- Last updated
- 30 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized, 2-Way Crossover, Open-Label Phase IV Study in Postmenopausal Women With Osteoporosis Examining Subject Satisfaction and Compliance When Actonel(Rosedronate) is Administered 35mg Once a Week or 5mg
- ClinicalTrials.gov ID
- NCT00549965
- Acronym / sponsor ID
- HMR4003B_4035
- Conditions
- Osteoporosis, Postmenopausal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- First posted
- 26 Oct 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.
Compare subject satisfaction of once a week dosing of 35 mg Risedronate to once daily dosing of 5 mg Risedronate in postmenopausal osteoporotic women. Secondary objectives are to measure compliance (50 % drug taken), and persistence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 55 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Five (5) years or greater postmenopausal who present with a diagnosis of postmenopausal osteoporosis based on standard clinical practice criteria.
- Subjects must discontinue bisphosphonates, calcitonin, fluoride, glucocorticoids (> than or = to 5 mg prednisone or equivalent per day) and hormone replacement therapy including estrogen-related compounds at least 6 months prior to randomization. During the study, these drugs are not permitted other than the study medication, Risedronate.
- Other concomitant medications should be kept to a minimum, but if the drugs are considered necessary for the subject's welfare and are unlikely to interfere with study medication they may be given at the discretion of the Investigator.
Key exclusion criteria (9 listed)
- Had a history of cancer within the past 5 years. Relatively benign skin malignancies, such as basal cell carcinoma or squamous cell carcinoma, are not an exclusion if the subject has been in remission for at least 6 months prior to enrollment.
- Diagnosis of hypocalcemia, hyperparathyroidism, and hyperthyroidism.
- History of alcohol and/or drug abuse.
- Subjects will be excluded for active gastrointestinal disease that may interfere with absorption or with ability to swallow an oral medication.
- Subjects will also be excluded for serious concurrent illness that would interfere with their ability to participate in the 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 Sodium | Drug | – |
Primary outcome
Measurement of subject satisfaction of once a week 35 mg Risedronate and once daily 5 mg Risedronate.
Time frame: A subject-administered questionnaire at 12 and 24 weeks will assess satisfaction.
1 secondary outcome
The subjects' compliance and persistence on treatment. Compliance as defined by more than 50% of the drug taken (by tablet count) during each Risedronate treatment period.
Time frame: Persistence at week 12 and 24 will be defined as continuing Risedronate treatment.
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 30 Oct 2007.
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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.
Choe Seong Choon 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 in people with Osteoporosis, Postmenopausal, run by Sanofi at 1 site in South Korea.
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 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 30 Oct 2007. 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 South Korea. 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?
Measurement of subject satisfaction of once a week 35 mg Risedronate and once daily 5 mg Risedronate. (time frame: A subject-administered questionnaire at 12 and 24 weeks will assess satisfaction.). 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 30 Oct 2007.