Status:
COMPLETED
A Study to Determine the Satisfaction With Actonel in Postmenopausal Women With Osteoporosis
Lead Sponsor:
Sanofi
Conditions:
Osteoporosis, Postmenopausal
Eligibility:
FEMALE
55-70 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
464 Patients enrolled
Trial Details
Trial ID
NCT00632216
Start Date
May 1 2004
End Date
May 1 2006
Last Update
March 11 2008
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