Clinical Study of Raloxifene and Strontium Ranelate in Postmenopausal Osteoporosis

Postmenopausal Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01544894
• Other study ID #: Sr-ral-postmOTP
• Status: Completed
• Phase: Phase 4
• First received: January 18, 2012
• Last updated: August 31, 2012
• Start date: September 2009
• Est. completion date: October 2011

Study information

• Verified date: August 2012
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

Inclusion Criteria:

• Postmenopausal women with densitometric osteoporosis

Exclusion Criteria:

• Secondary osteoporosis

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compliance
• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitario Dr Peset	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No