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| ID | Type | Description | Link |
|---|---|---|---|
| H4Z-MC-GJAV |
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The study is for Korean women who are postmenopausal and also suffer from osteoporosis.
The study will test if women who are given 20 mg of arzoxifene once a day for six months have a less severe level of osteoporosis than those women who do not take arzoxifene.
All patients will receive 500 mg of elemental calcium and 400 to 600 IU Vitamin D daily starting 4 weeks prior to study drug administration continuing through the 6 months of therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| arzoxifene | Drug | 20 mg, QD, PO,24 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Lumbar spine bone mineral density (BMD), by dual energy X-ray absorptiometry (DXA) analyses | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of spontaneous vaginal bleeding. | 6 months | |
| Total hip BMD | 6 months | |
| Biochemical marker of bone metabolism (serum CTX and PINP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bucheon-si | 420-767 |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C115121 | LY 353381 |
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| Placebo |
| Drug |
QD, PO, 24 weeks |
|
| 3 and to 6 months |
| Overall safety of arzoxifene administration in Korean postmenopausal women | 6 months |
| South Korea |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Seoul | 138-736 | South Korea |
| D009750 |
| Nutritional and Metabolic Diseases |