Trial record 9 of 171 for:
"Osteoporosis, Postmenopausal"
Risedronate Sodium in Post Menopausal Osteoporosis
This study has been completed.
Sponsor:
Sanofi
Collaborator:
Procter and Gamble
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00453492
First received: March 28, 2007
Last updated: March 10, 2008
Last verified: March 2008
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Purpose
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)].
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoporosis, Postmenopausal |
Drug: risedronate sodium |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Osteoporosis
Drug Information available for:
Risedronate sodium
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- 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.
| Estimated Enrollment: | 246 |
| Study Start Date: | January 2004 |
Eligibility| Ages Eligible for Study: | 55 Years to 80 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion criteria :
- 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.
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00453492 History of Changes |
| Other Study ID Numbers: | HMR4003B_4036 |
| Study First Received: | March 28, 2007 |
| Last Updated: | March 10, 2008 |
| Health Authority: | Turkey: Ministry of Health |
Additional relevant MeSH terms:
|
Osteoporosis, Postmenopausal Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Risedronic acid Etidronic Acid Bone Density Conservation Agents |
Physiological Effects of Drugs Pharmacologic Actions Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013