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: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Risedronate Sodium

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

Secondary Measures

• To measure response rates in CTX with Actonel 35 mg
  • Time Frame: Once A Week
    Safety Issue?: No

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

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

YEU Wang Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on October 10, 2008

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

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