Clinical Study of Raloxifene and Strontium Ranelate in Postmenopausal Osteoporosis

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Type :	Interventional (Clinical Trial)
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 :	September 2009
Actual Primary Completion Date :	October 2011
Actual Study Completion Date :	October 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. Clinical study of raloxifene and strontium ranelate in postmenopausal osteoporosis [ Time Frame: 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 :

1. Clinical study of raloxifene and strontium ranelate in postmenopausal osteoporosis [ Time Frame: 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.

Eligibility Criteria

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Ages Eligible for Study:	50 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• Postmenopausal women with densitometric osteoporosis

Exclusion Criteria:

• Secondary osteoporosis

Contacts and Locations

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Locations

Spain
Hospital Universitario Dr Peset
Valencia, Spain, 46017

Sponsors and Collaborators

University of Valencia

Investigators

Study Director:	Antonio Cano, MD	University of Valencia

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Antonio Cano Sanchez, Professor in Obstetrics and Gynecology, University of Valencia
ClinicalTrials.gov Identifier:	NCT01544894 History of Changes
Other Study ID Numbers:	Sr-ral-postmOTP
First Posted:	March 6, 2012
Last Update Posted:	September 3, 2012
Last Verified:	August 2012

Keywords provided by Antonio Cano Sanchez, University of Valencia:

Postmenopausal osteoporosis; Compliance; Bone mineral density; Bonemarkers

Additional relevant MeSH terms:

Osteoporosis; Osteoporosis, Postmenopausal; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Raloxifene Hydrochloride; Strontium ranelate	Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Bone Density Conservation Agents