Osteoporosis, Postmenopausal
Conditions
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.
Interventions
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 70 Years
Healthy volunteers
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the satisfaction of subject with Actonel 35 mg | Once a Week in the treatment of postmenopausal osteoporosis |
Secondary
| Measure | Time frame |
|---|---|
| To measure response rates in CTX with Actonel 35 mg | Once A Week |
Outcome results
None listed