Clinical Study of Raloxifene and Strontium Ranelate in Postmenopausal Osteoporosis

University of Valencia

Status and phase: Completed; Phase 4

Conditions: Postmenopausal Osteoporosis; Compliance

Treatments: Drug: Strontium ranelate; Drug: Raloxifene

Study type: Interventional

Funder types: Other

Identifiers

NCT01544894

Sr-ral-postmOTP

Details and patient eligibility

About

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 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.

Enrollment: 80 patients

Sex: Female

Ages: 50 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Postmenopausal women with densitometric osteoporosis

Exclusion criteria

• Secondary osteoporosis

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

raloxifene

Active Comparator group

Description:

60 mg/d for one year.

Treatment:

Drug: Raloxifene

strontium ranelate

Active Comparator group

Description:

2 g/d for one year.

Treatment:

Drug: Strontium ranelate