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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01544894
Other study ID # Sr-ral-postmOTP
Secondary ID
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


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
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