A Study to Determine the Satisfaction With Actonel in Postmenopausal Women With Osteoporosis

Sanofi464 enrolled

Overview

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

464

Conditions

Osteoporosis, Postmenopausal

Interventions

Risedronate SodiumDRUG

Eligibility

Sex: FEMALEMin age: 55 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

To determine the satisfaction of subject with Actonel 35 mg

Time frame: Once a Week in the treatment of postmenopausal osteoporosis

Secondary Outcomes

To measure response rates in CTX with Actonel 35 mg

Time frame: Once A Week

Data from ClinicalTrials.gov

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