Comparative Effect of Zoledronic Acid Versus Denosumab on Serum Sclerostin of Postmenopausal Women With Low Bone Mass

Summary

The primary aim of the study is the comparative effect of zolendronic acid versus denosumab on serum sclerostin levels in postmenopausal women with low bone mass. Secondary aims are their comparative effect on serum dickkopf-1, osteoprotegerin, receptor activator of nuclear factor kappaB ligand (RANKL) and bone turnover markers (procollagen type I N-terminal peptide \[PINP\] and C-terminal cross-linking telopeptide of type I collagen \[CTX\]).

Timeline

Start

2012-04

Primary completion

2012-09

Completion

2013-01

Publications

• Background Anastasilakis AD, Polyzos SA, Makras P, Sakellariou GT, Bisbinas I, Gkiomisi A, Delaroudis S, Gerou S, Ballaouri I, Oikonomou D, Papapoulos SE. Acute phase response following intravenous zoledronate in postmenopausal women with low bone mass. Bone. 2012 May;50(5):1130-4. doi: 10.1016/j.bone.2012.02.006. Epub 2012 Feb 15.
• Background Anastasilakis AD, Polyzos SA, Anastasilakis CD, Toulis KA, Makras P. Denosumab and bisphosphonates: rivals or potential "partners"? A "hybrid" molecule hypothesis. Med Hypotheses. 2011 Jul;77(1):109-11. doi: 10.1016/j.mehy.2011.03.039. Epub 2011 Apr 8.
• Background Polyzos SA, Anastasilakis AD, Bratengeier C, Woloszczuk W, Papatheodorou A, Terpos E. Serum sclerostin levels positively correlate with lumbar spinal bone mineral density in postmenopausal women--the six-month effect of risedronate and teriparatide. Osteoporos Int. 2012 Mar;23(3):1171-6. doi: 10.1007/s00198-010-1525-6. Epub 2011 Jan 11.
• Background Anastasilakis AD, Toulis KA, Polyzos SA, Terpos E. RANKL inhibition for the management of patients with benign metabolic bone disorders. Expert Opin Investig Drugs. 2009 Aug;18(8):1085-102. doi: 10.1517/13543780903048929.
• Background Anastasilakis AD, Toulis KA, Goulis DG, Polyzos SA, Delaroudis S, Giomisi A, Terpos E. Efficacy and safety of denosumab in postmenopausal women with osteopenia or osteoporosis: a systematic review and a meta-analysis. Horm Metab Res. 2009 Oct;41(10):721-9. doi: 10.1055/s-0029-1224109. Epub 2009 Jun 17.

Drugs

Indications