Clinical Study of Raloxifene and Strontium Ranelate in Postmenopausal Osteoporosis

Overview

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

Full Title of Study: “Comparison of Raloxifene and Strontium Ranelate on Compliance and Efficacy in Women With Postmenopausal Osteoporosis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2011

Detailed Description

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.

Interventions

  • Drug: Raloxifene
    • 60 mg/d for one year
  • Drug: Strontium ranelate
    • 2 g/d, for one year

Arms, Groups and Cohorts

  • Active Comparator: raloxifene
    • 60 mg/d for one year.
  • Active Comparator: strontium ranelate
    • 2 g/d for one year.

Clinical Trial Outcome Measures

Primary Measures

  • Clinical study of raloxifene and strontium ranelate in postmenopausal osteoporosis
    • Time Frame: One year
    • 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.

Secondary Measures

  • Clinical study of raloxifene and strontium ranelate in postmenopausal osteoporosis
    • Time Frame: One year
    • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Postmenopausal women with densitometric osteoporosis

Exclusion Criteria

  • Secondary osteoporosis

Gender Eligibility: Female

Minimum Age: 50 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Valencia
  • Provider of Information About this Clinical Study
    • Principal Investigator: Antonio Cano Sanchez, Professor in Obstetrics and Gynecology – University of Valencia
  • Overall Official(s)
    • Antonio Cano, MD, Study Director, University of Valencia

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