Osteoporosis Treatment with Denosumab: Our Experience in the Real Clinical Practice

GONZALEZ D; OLIVERI B; BAGUR A; MAUTALEN C

HOUSTON

Congreso; Meeting America Society for Bone and Mineral Research; 2014

Randomized controlled trials have demonstrated that subcutaneous denosumab (DNB), a fully human monoclonal antibody against the receptor activador of nuclear factor kB ligand (RANKL), ensures an effective anti-osteoporotic treatment. In the pivotal trials previous use of IV bisphosphonate was an exclusion criterion while previous oral bisphosphonates were allowed after a long wash out period. Other trials showed DNB effectiveness in patients previously treated with bisphosphonates without wash out period. The aim of this study was to report our experience with DNB in the real clinical practice in patients with osteoporosis. Subjects and Methods: osteoporotic women who received one or two doses of DNB during the period from 2011 to 2013 were included. The following issues were analyzed: a) Biochemical markers of bone turnover: serum Crosslaps (sCTX), Bone Gla Protein (BGP) and Bone Remodeling Index (BRI) at baseline, 6 (range: 5-7) months after the first dose of DNB, and at one year of treatment (six months after the second dose of DNB). b) Bone mineral density (BMD) of the lumbar spine (LS), femoral neck (FN) and total femur (TF) at baseline and one year of treatment. Results: Seventy-five postmenopausal women with mean (X±SD) 67.0+9 years-old were included. Seven out of 75 women were naive of bisphosphonate treatment. Sixty-eight patients had been treated with bisphosphonates during 5.8±4 years. The 41.3% of the patients had history of fragility fractures. Biochemical determination and BMD values at baseline, 6 months and 12 months of treatment with DNB are shown in the table. The percent change from baseline in BMD was +6.5% (p