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

January 18, 2012
August 31, 2012
September 2009
October 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01544894 on ClinicalTrials.gov Archive Site
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.

Same as current
Not Provided
Not Provided
 
Clinical Study of Raloxifene and Strontium Ranelate in Postmenopausal Osteoporosis
Comparison of Raloxifene and Strontium Ranelate on Compliance and Efficacy in Women With Postmenopausal Osteoporosis

The purpose of this study was to compare compliance and efficacy of raloxifene and strontium ranelate in a group of women with postmenopausal osteoporosis.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Postmenopausal Osteoporosis
  • Compliance
  • Drug: Raloxifene
    60 mg/d for one year
    Other Name: Evista
  • Drug: Strontium ranelate
    2 g/d, for one year
    Other Name: Protelos
  • Active Comparator: raloxifene
    60 mg/d for one year.
    Intervention: Drug: Raloxifene
  • Active Comparator: strontium ranelate
    2 g/d for one year.
    Intervention: Drug: Strontium ranelate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
October 2011
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Postmenopausal women with densitometric osteoporosis

Exclusion Criteria:

  • Secondary osteoporosis
Female
50 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01544894
Sr-ral-postmOTP
No
Antonio Cano Sanchez, University of Valencia
University of Valencia
Not Provided
Study Director: Antonio Cano, MD University of Valencia
University of Valencia
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP