Back to resultsClinical Study of Raloxifene and Strontium Ranelate in Postmenopausal Osteoporosis
Primary Purpose
Postmenopausal Osteoporosis, Compliance
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Raloxifene
Strontium ranelate
Sponsored by
About this trial
This is an interventional treatment trial for Postmenopausal Osteoporosis focused on measuring Postmenopausal osteoporosis, Compliance, Bone mineral density, Bonemarkers
Eligibility Criteria
Inclusion Criteria:
- Postmenopausal women with densitometric osteoporosis
Exclusion Criteria:
- Secondary osteoporosis
Sites / Locations
- Hospital Universitario Dr Peset
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
raloxifene
strontium ranelate
Arm Description
60 mg/d for one year.
2 g/d for one year.
Outcomes
Primary Outcome Measures
Clinical study of raloxifene and strontium ranelate in postmenopausal osteoporosis
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
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.
Full Information
NCT ID
NCT01544894
First Posted
January 18, 2012
Last Updated
August 31, 2012
Sponsor
University of Valencia
1. Study Identification
Unique Protocol Identification Number
NCT01544894
Brief Title
Clinical Study of Raloxifene and Strontium Ranelate in Postmenopausal Osteoporosis
Official Title
Comparison of Raloxifene and Strontium Ranelate on Compliance and Efficacy in Women With Postmenopausal Osteoporosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporosis, Compliance
Keywords
Postmenopausal osteoporosis, Compliance, Bone mineral density, Bonemarkers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
raloxifene
Arm Type
Active Comparator
Arm Description
60 mg/d for one year.
Arm Title
strontium ranelate
Arm Type
Active Comparator
Arm Description
2 g/d for one year.
Intervention Type
Drug
Intervention Name(s)
Raloxifene
Other Intervention Name(s)
Evista
Intervention Description
60 mg/d for one year
Intervention Type
Drug
Intervention Name(s)
Strontium ranelate
Other Intervention Name(s)
Protelos
Intervention Description
2 g/d, for one year
Primary Outcome Measure Information:
Title
Clinical study of raloxifene and strontium ranelate in postmenopausal osteoporosis
Description
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.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Clinical study of raloxifene and strontium ranelate in postmenopausal osteoporosis
Description
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.
Time Frame
One year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Postmenopausal women with densitometric osteoporosis
Exclusion Criteria:
Secondary osteoporosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Cano, MD
Organizational Affiliation
University of Valencia
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Universitario Dr Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Clinical Study of Raloxifene and Strontium Ranelate in Postmenopausal Osteoporosis
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