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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Postmenopausal Osteoporosis Compliance | Drug: Raloxifene Drug: Strontium ranelate | Phase 4 |
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 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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: raloxifene
60 mg/d for one year.
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Drug: Raloxifene
60 mg/d for one year
Other Name: Evista |
Active Comparator: strontium ranelate
2 g/d for one year.
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Drug: Strontium ranelate
2 g/d, for one year
Other Name: Protelos |
- 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.
- 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.

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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 |
Inclusion Criteria:
- Postmenopausal women with densitometric osteoporosis
Exclusion Criteria:
- Secondary osteoporosis

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
Spain | |
Hospital Universitario Dr Peset | |
Valencia, Spain, 46017 |
Study Director: | Antonio Cano, MD | University of Valencia |
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 |
Postmenopausal osteoporosis Compliance Bone mineral density Bonemarkers |
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 |