Osteoporosis, PostmenopausalPhase 4NCT00453492
Risedronate Sodium in Post Menopausal Osteoporosis
A Phase 4 study testing risedronate sodium in people with Osteoporosis, Postmenopausal, run by Sanofi at 1 site in Turkey (Türkiye).
Trial summary
The primary objective is to compare subject satisfaction of once a week dosing of 35 mg Actonel to once daily dosing of 5 mg Actonel in postmenopausal osteoporotic women. The secondary objectives are to measure compliance (50 % drug taken), and persistence, [and urinary NTx (N-telopeptides) (optional)]. 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
- 246 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2004to 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 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 (≥ 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, Actonel.
- 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 criteria if the subject has been in remission for at least 6 months prior to enrollment.
- Diagnosis of hypocalcemia, hyperparathyroidism, and hyperthyroidism.
- 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 Study pn Postmenopausal Women With Osteoporosis Examining Subject Satisfaction and Compliance When Risedronate Sodium (Actonel) in Administered 35mg Once a Week or 5mg Once Daily
The primary objective is to compare subject satisfaction of once a week dosing of 35 mg Actonel to once daily dosing of 5 mg Actonel in postmenopausal osteoporotic women.
The secondary objectives are to measure compliance (50 % drug taken), and persistence, [and urinary NTx (N-telopeptides) (optional)].
- 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 using a questionnaire at 12 and 24 weeks and a tablets counts at 12 and 24 weeks.
Optional: the effects of Actonel on bone resorption will be assessed by a change of urinary NTx, after 12 and 24 weeks of treatment as compared to baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2007 (estimated)
- Study startJan 2004
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
- 246 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Procter and Gamble
- Investigators
- Edibe Taylan, Study director, Sanofi-aventis, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00453492
- Sponsor's protocol ID
- HMR4003B_4036
- Status last verified
- Mar 2008
- First submitted
- 28 Mar 2007
- Last updated
- 11 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized, 2-Way Crossover, Open-Label Study pn Postmenopausal Women With Osteoporosis Examining Subject Satisfaction and Compliance When Risedronate Sodium (Actonel) in Administered 35mg Once a Week or 5mg Once Daily
- ClinicalTrials.gov ID
- NCT00453492
- Acronym / sponsor ID
- HMR4003B_4036
- Conditions
- Osteoporosis, Postmenopausal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Procter and Gamble
- Study start
- Jan 2004
- First posted
- 29 Mar 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 primary objective is to compare subject satisfaction of once a week dosing of 35 mg Actonel to once daily dosing of 5 mg Actonel in postmenopausal osteoporotic women.
The secondary objectives are to measure compliance (50 % drug taken), and persistence, [and urinary NTx (N-telopeptides) (optional)].
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 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 (≥ 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, Actonel.
- 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 (3 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 criteria if the subject has been in remission for at least 6 months prior to enrollment.
- Diagnosis of hypocalcemia, hyperparathyroidism, and hyperthyroidism.
- 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 sodium | Drug | – |
Primary outcome
Measurement of subject satisfaction using a questionnaire at 12 and 24 weeks and a tablets counts at 12 and 24 weeks.
Optional: the effects of Actonel on bone resorption will be assessed by a change of urinary NTx, after 12 and 24 weeks of treatment as compared to baseline.
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 Mar 2008.
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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.
Edibe Taylan study director
Sanofi-aventis, Turkey
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 Turkey (Türkiye).
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 Mar 2008. 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 Turkey (Türkiye). 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 using a questionnaire at 12 and 24 weeks and a tablets counts at 12 and 24 weeks.. The study lists 2 primary outcomes in all. 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 11 Mar 2008.