We conducted a study to investigate the time course changes in bone metabolic markers after the administration of anti-receptor activator of nuclear factor-kappa β ligand (RANKL) antibody and prevention to bone fracture among aged osteoporotic patients. Anti-RANKL antibody is expected to provide an improvement in those with a bone metabolism disorder. We included total 65 aged osteoporotic patients who received anti-RANKL antibody and bisphosphonate or SERM (BP/SERM) treatment, 31 vs 34 respectively. To determine the time course changes in the bone metabolic markers, we measured the serum tartrate-resistant acid phosphatase 5b (TRACP 5b; a bone resorption marker) and the serum lower undercaboxylated osteocalcin (ucOC; a bone matrix related marker) levels prior to and about 1 year after administrating anti-RANKL antibody. To evaluable drug compliance, we assessed the dropout rate during treatment and at about 1 year after treatment. The average TRACP 5b and ucOC level significantly decreased 451.3 mU/dl before treatment to 142.6 mU/dl(p<0.001), 7.71 ng/ml before treatment to 1.26 ng/ml (p<0.001) respectively, at after treatment.
The bone fracture occurred for only at the time of the fall down. Number of fall down occurred in anti-RANKL antibody group and BP/SERM group was 16 vs 15 respectively, and there was not significant difference. But the number of bone fractures each the anti-RANKL antibody group and BP/SERM group was significantly difference (odds ratio 0.015).
Our study suggests that anti-RANKL antibody is very safety treatment, and suppresses bone resorption and maintains bone formation. In addition, prevention to bone fracture complication in aged patient having easy fall down.