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Clinical Study of Raloxifene and Strontium Ranelate in Postmenopausal Osteoporosis

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ClinicalTrials.gov Identifier: NCT01544894
Recruitment Status : Completed
First Posted : March 6, 2012
Last Update Posted : September 3, 2012
Sponsor:
Information provided by (Responsible Party):
Antonio Cano Sanchez, University of Valencia

Study Description
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
Drug Information available for: Raloxifene

Arms and Interventions
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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, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01544894


Locations
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Spain
Hospital Universitario Dr Peset
Valencia, Spain, 46017
Sponsors and Collaborators
University of Valencia
Investigators
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Study Director: Antonio Cano, MD University of Valencia
More Information
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Responsible Party: Antonio Cano Sanchez, Professor in Obstetrics and Gynecology, University of Valencia
ClinicalTrials.gov Identifier: NCT01544894    
Other Study ID Numbers: Sr-ral-postmOTP
First Posted: March 6, 2012    Key Record Dates
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:
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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