Effects of Arzoxifene on Bone Fractures and Incidence of Breast Cancer
Summary
The purpose of this trial is to study: * Effects of arzoxifene on bone fractures and bone mass. * Effects of arzoxifene on getting breast cancer. * Effects of arzoxifene on certain types of cardiovascular events, such as heart attack and stroke. * Effects of arzoxifene that changes the amount of certain substances in the blood that are related to osteoporosis and cardiovascular health. * Effects of arzoxifene on the uterus. * The safety of arzoxifene and any side effects.
Timeline
- Start
- 2004-06
- Primary completion
- 2009-06
- Completion
- 2009-11
Outcome
Met primary endpoint
paper the cumulative incidence of vertebral fractures in patients with osteoporosis was 2.3% lower in the arzoxifene group than in the placebo group PMID 20658564 ↗
paper a 41% relative risk reduction [95% confidence interval (CI) 0.45-0.77, p < .001]. PMID 20658564 ↗
paper the cumulative incidence of invasive breast cancer over 4 years was reduced by 1.3% PMID 20658564 ↗
paper a 56% relative reduction in risk (hazard ratio = 0.44, 95% CI 0.26-0.76, p < .001); PMID 20658564 ↗
release “Phase III GJAD "GENERATIONS" trial for arzoxifene met its primary endpoints” lilly.com ↗
Publications
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | arzoxifene | Other / unclassified | 20 mg | Oral |