Clinical Study of Raloxifene and Strontium Ranelate in Postmenopausal Osteoporosis
Drug: Strontium ranelate
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Comparison of Raloxifene and Strontium Ranelate on Compliance and Efficacy in Women With Postmenopausal Osteoporosis|
- Clinical study of raloxifene and strontium ranelate in postmenopausal osteoporosis [ Time Frame: One year ] [ Designated as safety issue: No ]Primary Outcome measure: compliance. Assessment of compliance assessed two variables, the number of participants maintaining treatment after one year and, among those that completed the one year treatment, the number of them that completed at least 80% of the prescribed dose.
- Clinical study of raloxifene and strontium ranelate in postmenopausal osteoporosis [ Time Frame: One year ] [ Designated as safety issue: No ]
Secondary outcome measure: efficacy. Efficacy has been assessed by changes in axial bone mineral density (spine and hip) and by changes in biochemical bone markers (C-telopeptides and P1NP in serum).
Axial densitometry has been performed prior to treatment and after completion of the programmed one-year treatment.
Bone markers have been assessed prior to treatment and at the 3rd, 6th and 12th month of treatment.
|Study Start Date:||September 2009|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Active Comparator: raloxifene
60 mg/d for one year.
60 mg/d for one year
Other Name: Evista
Active Comparator: strontium ranelate
2 g/d for one year.
Drug: Strontium ranelate
2 g/d, for one year
Other Name: Protelos
OBJECTIVE: To compare the performance of raloxifene and strontium rannelate in the management of women with postmenopausal osteoporosis.
DESIGN: Prospective, open label study. SETTING: University hospital menopause unit. PATIENTS: 80 women with postmenopausal osteoporosis were assigned to either raloxifene (60 mg/d) or strontium ranelate (2g/d). Participants were followed for 1 year.
MAIN OUTCOME MEASURE(S): Compliance with each regime. Secondary objectives were parameters of efficacy, including changes in bone mineral density and bone biochemical markers.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01544894
|Hospital Universitario Dr Peset|
|Valencia, Spain, 46017|
|Study Director:||Antonio Cano, MD||University of Valencia|