A Study to Determine the Satisfaction With Actonel in Postmenopausal Women With Osteoporosis (ROSPA-CTx)

Sanofi

Status and phase: Completed; Phase 4

Conditions: Osteoporosis, Postmenopausal

Treatments: Drug: Risedronate Sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00632216

RISED_L_01054

Details and patient eligibility

About

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.

Enrollment: 464 patients

Sex: Female

Ages: 55 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)