Clinical Study of Raloxifene and Strontium Ranelate in Postmenopausal Osteoporosis

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Antonio Cano Sanchez, University of Valencia

ClinicalTrials.gov Identifier:

NCT01544894

First received: January 18, 2012

Last updated: August 31, 2012

Last verified: August 2012

History of Changes

Purpose

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	Intervention	Phase
Postmenopausal Osteoporosis Compliance	Drug: Raloxifene Drug: Strontium ranelate	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Comparison of Raloxifene and Strontium Ranelate on Compliance and Efficacy in Women With Postmenopausal Osteoporosis

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis

Drug Information available for: Raloxifene hydrochloride Raloxifene

U.S. FDA Resources

Further study details as provided by University of Valencia:

Primary Outcome Measures:

Clinical study of raloxifene and strontium ranelate in postmenopausal osteoporosis [ Time Frame: One year ] [ Designated as safety issue: No ]
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 [ Time Frame: One year ] [ Designated as safety issue: No ]
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.


Enrollment:	80
Study Start Date:	September 2009
Study Completion Date:	October 2011
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	50 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Postmenopausal women with densitometric osteoporosis

Exclusion Criteria:

Secondary osteoporosis

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544894

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

No publications provided


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
Study First Received:	January 18, 2012
Last Updated:	August 31, 2012
Health Authority:	Spain: Comité Ético de Investigación Clínica

Keywords provided by University of Valencia:


Postmenopausal osteoporosis Compliance Bone mineral density Bonemarkers

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on March 03, 2015

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