Clinical Study of Raloxifene and Strontium Ranelate in Postmenopausal Osteoporosis

Sponsor

University of Valencia (Other)

Overall Status

Completed

CT.gov ID

NCT01544894

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postmenopausal Osteoporosis Compliance	Drug: Raloxifene Drug: Strontium ranelate	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: raloxifene 60 mg/d for one year.	Drug: Raloxifene 60 mg/d for one year Other Names: Evista
Active Comparator: strontium ranelate 2 g/d for one year.	Drug: Strontium ranelate 2 g/d, for one year Other Names: Protelos

Arm

Intervention/Treatment

Active Comparator: raloxifene

60 mg/d for one year.

Drug: Raloxifene

60 mg/d for one year

Other Names:

Evista

Active Comparator: strontium ranelate

2 g/d for one year.

Drug: Strontium ranelate

2 g/d, for one year

Other Names:

Protelos

Outcome Measures

Primary Outcome Measures

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

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.