Clinical Study of Raloxifene and Strontium Ranelate in Postmenopausal Osteoporosis

Study Overview
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Brief Summary
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The purpose of this study was to compare compliance and efficacy of raloxifene and strontium ranelate in a group of women with postmenopausal osteoporosis.

Detailed Description
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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.

Official Title
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Comparison of Raloxifene and Strontium Ranelate on Compliance and Efficacy in Women With Postmenopausal Osteoporosis

Conditions
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Compliance, Postmenopausal Osteoporosis

Intervention / Treatment
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* Drug: Raloxifene
* Drug: Strontium ranelate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal women with densitometric osteoporosis Exclusion Criteria: Secondary osteoporosis

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: raloxifene<br>60 mg/d for one year. | Drug: Raloxifene<br>* 60 mg/d for one year<br>* Other names: Evista;|
| Active Comparator: strontium ranelate<br>2 g/d for one year. | Drug: Strontium ranelate<br>* 2 g/d, for one year<br>* Other names: Protelos;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical study of raloxifene and strontium ranelate in postmenopausal osteoporosis | 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. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical study of raloxifene and strontium ranelate in postmenopausal osteoporosis | 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. | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postmenopausal osteoporosis, Compliance, Bone mineral density, Bonemarkers