Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| H4Z-MC-GJAD | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this trial is to study:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arzoxifene | Drug | 20mg, oral, tablet, once a day for 36 months |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Effects of arzoxifene on bone fractures and bone mass | 5 years | |
| Effects of arzoxifene on getting breast cancer | 5 years | |
| The safety of arzoxifene and any side effects | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of arzoxifene on certain types of cardiovascular events | 5 years | |
| Effects of arzoxifene that changes the amount of certain substances in the blood that are related to osteoporosis and cardiovascular health | 5 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Elk Grove | Illinois | 60007 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23758943 | Derived | e Silva AV, Lacativa PG, Russo LA, de Gregorio LH, Pinheiro RA, Marinheiro LP. Association of back pain with hypovitaminosis D in postmenopausal women with low bone mass. BMC Musculoskelet Disord. 2013 Jun 12;14:184. doi: 10.1186/1471-2474-14-184. | |
| 22484799 | Derived | Powles TJ, Diem SJ, Fabian CJ, Neven P, Wickerham DL, Cox DA, Muram D, Agnusdei D, Dowsett SA, Amewou-Atisso M, Cummings SR. Breast cancer incidence in postmenopausal women with osteoporosis or low bone mass using arzoxifene. Breast Cancer Res Treat. 2012 Jul;134(1):299-306. doi: 10.1007/s10549-012-2041-5. Epub 2012 Apr 8. |
Not provided
Not provided
| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C115121 | LY 353381 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | oral, tablet, once a day for 36 months |
|
| Effects of arzoxifene on the uterus | 5 years |
| Effects of arzoxifene on cognition | 5 years |
| Effects of arzoxifene on back pain | 5 years |
| United States |
| 21993078 | Derived | Goldstein SR, Bhattoa HP, Neven P, Cox DA, Dowsett SA, Alam J, Sipos A, Muram D. Gynecologic effects of arzoxifene in postmenopausal women with osteoporosis or low bone mass. Menopause. 2012 Jan;19(1):41-7. doi: 10.1097/gme.0b013e318223bbf4. |
| 20658564 | Derived | Cummings SR, McClung M, Reginster JY, Cox D, Mitlak B, Stock J, Amewou-Atisso M, Powles T, Miller P, Zanchetta J, Christiansen C. Arzoxifene for prevention of fractures and invasive breast cancer in postmenopausal women. J Bone Miner Res. 2011 Feb;26(2):397-404. doi: 10.1002/jbmr.191. Epub 2010 Jul 23. |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |