The Deferasirox-calcium-vitamin D3 Therapy for Postmenopausal Osteoporosis (PMOP)
Summary
In 2006, Weinberg proposed a hypothesis that iron accumulation was a risk factor for osteoporosis. Osteoporosis is a common complication in various diseases, such as hemochromatosis, African hemosiderosis, thalassemia, and sickle cell disease, which all share iron accumulation as a common denominator. Moreover, a 3-year retrospective longitudinal study has shown that iron accumulation was also associated with osteoporosis in healthy adults and especially that it can increase the risk of fractures in postmenopausal women. Based on these observations, iron chelation therapy may have a promising future in the treatment of iron accumulation-related osteoporosis by removing iron from the body. The purpose of this study is to determine whether the addition of the iron chelator, deferasirox, to standard therapy for postmenopausal osteoporosis, is safe and effective.
Timeline
- Start
- 2018-01-15
- Primary completion
- 2019-06-15
- Completion
- 2020-06-15
Publications
- Background Kim BJ, Ahn SH, Bae SJ, Kim EH, Lee SH, Kim HK, Choe JW, Koh JM, Kim GS. Iron overload accelerates bone loss in healthy postmenopausal women and middle-aged men: a 3-year retrospective longitudinal study. J Bone Miner Res. 2012 Nov;27(11):2279-90. doi: 10.1002/jbmr.1692.
- Background Mitchell F. Bone: high body iron stores lead to bone loss. Nat Rev Endocrinol. 2012 Sep;8(9):506. doi: 10.1038/nrendo.2012.127. Epub 2012 Jul 17. No abstract available.
- Background Li GF, Pan YZ, Sirois P, Li K, Xu YJ. Iron homeostasis in osteoporosis and its clinical implications. Osteoporos Int. 2012 Oct;23(10):2403-8. doi: 10.1007/s00198-012-1982-1. Epub 2012 Apr 14.
- Background Huang X, Xu Y, Partridge NC. Dancing with sex hormones, could iron contribute to the gender difference in osteoporosis? Bone. 2013 Aug;55(2):458-60. doi: 10.1016/j.bone.2013.03.008. Epub 2013 Mar 22. No abstract available.
- Background Chen B, Yan YL, Liu C, Bo L, Li GF, Wang H, Xu YJ. Therapeutic effect of deferoxamine on iron overload-induced inhibition of osteogenesis in a zebrafish model. Calcif Tissue Int. 2014 Mar;94(3):353-60. doi: 10.1007/s00223-013-9817-4. Epub 2014 Jan 12.
- Background Chen B, Li GF, Shen Y, Huang XI, Xu YJ. Reducing iron accumulation: A potential approach for the prevention and treatment of postmenopausal osteoporosis. Exp Ther Med. 2015 Jul;10(1):7-11. doi: 10.3892/etm.2015.2484. Epub 2015 May 8.
- Background Shen GS, Yang Q, Jian JL, Zhao GY, Liu LL, Wang X, Zhang W, Huang X, Xu YJ. Hepcidin1 knockout mice display defects in bone microarchitecture and changes of bone formation markers. Calcif Tissue Int. 2014 Jun;94(6):632-9. doi: 10.1007/s00223-014-9845-8. Epub 2014 Mar 21.
- Background Xu Y, Li G, Du B, Zhang P, Xiao L, Sirois P, Li K. Hepcidin increases intracellular Ca2+ of osteoblast hFOB1.19 through L-type Ca2+ channels. Regul Pept. 2011 Dec 10;172(1-3):58-61. doi: 10.1016/j.regpep.2011.08.009. Epub 2011 Sep 10.
- Background Jia P, Xu YJ, Zhang ZL, Li K, Li B, Zhang W, Yang H. Ferric ion could facilitate osteoclast differentiation and bone resorption through the production of reactive oxygen species. J Orthop Res. 2012 Nov;30(11):1843-52. doi: 10.1002/jor.22133. Epub 2012 May 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Deferasirox | Unknown | 10 mg/kg | Oral |
| Background | Calcium carbonate | Other / unclassified | 500 mg | — |
| Background | Cholecalciferol | Other / unclassified | 800 iu | — |