Clinical Study of Raloxifene and Strontium Ranelate in Postmenopausal Osteoporosis

Phase 4

Completed

• Conditions: Postmenopausal Osteoporosis; Compliance
• Interventions: Drug: Strontium ranelate; Drug: Raloxifene

• Registration Number: NCT01544894
• Lead Sponsor: University of Valencia

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Study First Submitted: 2012-01-18
• Study First Submitted QC: 2012-02-29
• Study First Posted: 2012-03-06
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-31
• Last Update Posted: 2012-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• Postmenopausal women with densitometric osteoporosis

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Exclusion Criteria

• Secondary osteoporosis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
strontium ranelate	Strontium ranelate	2 g/d for one year.
raloxifene	Raloxifene	60 mg/d for one year.

Primary Outcome Measures

Name	Time	Method
Clinical study of raloxifene and strontium ranelate in postmenopausal osteoporosis	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 Outcome Measures

Name	Time	Method
Clinical study of raloxifene and strontium ranelate in postmenopausal osteoporosis	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.

Trial Locations

Locations (1)

Hospital Universitario Dr Peset; 🇪🇸 Valencia, Spain