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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| raloxifene | Active Comparator | 60 mg/d for one year. |
|
| strontium ranelate | Active Comparator | 2 g/d for one year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Raloxifene | Drug | 60 mg/d for one year |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Cano, MD | University of Valencia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Dr Peset | Valencia | Valencia | 46017 | Spain |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D020849 | Raloxifene Hydrochloride |
| C081587 | strontium ranelate |
| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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| Strontium ranelate | Drug | 2 g/d, for one year |
|
|
| One year |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |