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

ClinicalTrials.gov processed this record on May 19, 2013