A Study to Determine the Satisfaction With Actonel in Postmenopausal Women With Osteoporosis
The study in the labeled and real conditions of prescription of Actonel will investigate the satisfaction of patients with its new formulation: 35 mg Once A Week. The study will also measure response rates in CTX (the C-telopeptide of type I collagen) at baseline and after 12 weeks of treatment with risedronate 35 mg Once A Week...
Brief Summary
Official Title: “Multicenter and Prospective Study to Determine the Satisfaction With Actonel (Risedronate Sodium) 35mg Once a Week Using Biochemical Markers of Bone as a Control, in Postmenopausal Women With Osteoporosis”
The study in the labeled and real conditions of prescription of Actonel will investigate the satisfaction of patients with its new formulation: 35 mg Once A Week. The study will also measure response rates in CTX (the C-telopeptide of type I collagen) at baseline and after 12 weeks of treatment with risedronate 35 mg Once A Week.
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Risedronate Sodium
Outcome Measures for this Clinical Trial
Primary Measures
- To determine the satisfaction of subject with Actonel 35 mg
- Time Frame: Once a Week in the treatment of postmenopausal osteoporosis
Safety Issue?: No
- Time Frame: Once a Week in the treatment of postmenopausal osteoporosis
Secondary Measures
- To measure response rates in CTX with Actonel 35 mg
- Time Frame: Once A Week
Safety Issue?: No
- Time Frame: Once A Week
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Postmenopausal outpatients women > 55 and < 70 years who have a clinical presentation appropriate for treatment of established osteoporosis based on the investigator's clinical judgment (a T-score for BMD (DEXA) of lumbar spine or femoral neck less than or equal to - 2.5 from an assessment performed at screening or within 12 months prior to the screening visit or evidence of previous vertebral fracture).
Exclusion Criteria:
- History of Cancer: Basal Cell or Squamous Cell carcinoma-documented 6-month remission.
- Diagnosis of hypocalcemia, hyperparathyroidism, hyperthyroidism.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 55 Years
Maximum Age for this Clinical Trial: 70 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Sanofi-Aventis Industry
Overall Clinical Trial Officials and Contacts
YEU Wang Study Director Sanofi-Aventis
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00632216
Study ID Number: RISED_L_01054
ClinicalTrials.gov Identifier: NCT00632216
Health Authority: Brazil: National Committee of Ethics in Research
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00632216
