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| Sponsor: | Eli Lilly and Company |
|---|---|
| Information provided by: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00670319 |
Purpose
To study the effect of long-term treatment with raloxifene, compared with placebo, on the rate of new vertebral fractures in osteoporotic postmenopausal women with and without existing vertebral fractures.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoporosis, Postmenopausal |
Drug: Raloxifene HCL Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Comparison of Raloxifene Hydrochloride and Placebo in the Treatment of Postmenopausal Women With Osteoporosis |
| Enrollment: | 7705 |
| Study Start Date: | November 1994 |
| Study Completion Date: | September 1999 |
| Primary Completion Date: | September 1999 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Raloxifene HCL 60 mg orally once a day
|
Drug: Raloxifene HCL
Raloxifene HCL 60 mg orally once daily
|
|
2: Experimental
Raloxifene HCL 120 mg orally once a day
|
Drug: Raloxifene HCL
Raloxifene HCL 120 mg orally once daily
|
| 3: Placebo Comparator |
Drug: Placebo
Placebo one tab orally per day
|
Eligibility| Ages Eligible for Study: | up to 80 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 25 Study Locations| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
More Information
| Responsible Party: | Eli Lilly ( Chief Medical Officer ) |
| Study ID Numbers: | 1363, H3S-MC-GGGK |
| Study First Received: | April 29, 2008 |
| Last Updated: | April 30, 2008 |
| ClinicalTrials.gov Identifier: | NCT00670319 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Estrogen Antagonists Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Osteoporosis Bone Diseases, Metabolic Bone Density Conservation Agents |
Selective Estrogen Receptor Modulators Bone Diseases Pharmacologic Actions Estrogen Receptor Modulators Raloxifene Musculoskeletal Diseases Osteoporosis, Postmenopausal |