Postmenopausal Osteoporosis Clinical Trial
Official title:
Comparison of Raloxifene and Strontium Ranelate on Compliance and Efficacy in Women With Postmenopausal Osteoporosis
Verified date | August 2012 |
Source | University of Valencia |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Comité Ético de Investigación Clínica |
Study type | Interventional |
The purpose of this study was to compare compliance and efficacy of raloxifene and strontium ranelate in a group of women with postmenopausal osteoporosis.
Status | Completed |
Enrollment | 80 |
Est. completion date | October 2011 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 50 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Postmenopausal women with densitometric osteoporosis Exclusion Criteria: - Secondary osteoporosis |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario Dr Peset | Valencia |
Lead Sponsor | Collaborator |
---|---|
University of Valencia |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | One year | No |
Secondary | 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. |
One year | No |
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