Clinical Study of Raloxifene and Strontium Ranelate in Postmenopausal Osteoporosis

NCT ID: NCT01544894

Last Updated: 2012-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-10-31

Brief Summary

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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

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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.

Conditions

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Postmenopausal Osteoporosis Compliance

Keywords

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Postmenopausal osteoporosis Compliance Bone mineral density Bonemarkers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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raloxifene

60 mg/d for one year.

Group Type ACTIVE_COMPARATOR

Raloxifene

Intervention Type DRUG

60 mg/d for one year

strontium ranelate

2 g/d for one year.

Group Type ACTIVE_COMPARATOR

Strontium ranelate

Intervention Type DRUG

2 g/d, for one year

Interventions

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Raloxifene

60 mg/d for one year

Intervention Type DRUG

Strontium ranelate

2 g/d, for one year

Intervention Type DRUG

Other Intervention Names

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Evista Protelos

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal women with densitometric osteoporosis

Exclusion Criteria

* Secondary osteoporosis
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Valencia

OTHER

Sponsor Role lead

Responsible Party

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Antonio Cano Sanchez

Professor in Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antonio Cano, MD

Role: STUDY_DIRECTOR

University of Valencia

Locations

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Hospital Universitario Dr Peset

Valencia, Valencia, Spain

Site Status

Countries

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Spain

Other Identifiers

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Sr-ral-postmOTP

Identifier Type: -

Identifier Source: org_study_id