A Study to Determine the Satisfaction With Actonel in Postmenopausal Women With Osteoporosis
Phase 4
Completed
- Conditions
- Osteoporosis, Postmenopausal
- Registration Number
- NCT00632216
- Lead Sponsor
- Sanofi
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 464
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To determine the satisfaction of subject with Actonel 35 mg Once a Week in the treatment of postmenopausal osteoporosis
- Secondary Outcome Measures
Name Time Method To measure response rates in CTX with Actonel 35 mg Once A Week