Therapeutic Research

Abstract

Objective：We had reported the efficacy of monthly oral ibandronate（IBN）100 mgcompared with monthly intravenous（IV）IBN 1 mg in the randomized double‒blind MOVEST study, and dose response was examined in the Phase Ⅱ study. We describe here the efficacy of both IBN treatments with respect to the suppression of the bone resorption markers. Material and Methods：Ambulatory Japanese patients aged≧55 years with primary osteoporosis were randomized to receive monthly oral IBN 100 mg＋monthly IV placebo, or monthly IV IBN 1 mg＋monthly oral placebo in the MOVEST study. The primary endpoint was non‒inferiority of oral vs IV IBN with respect to BMD gains at the lumbar spine after 12 months in the study. The changes of bone resorption markers such as urinary CTX, serum TRACP‒5b and urinary NTX were examined at baseline, 1, 3, 6, and 12 months. In the Phase Ⅱ study, the relative changes of urinary CTX were measured in details during the treatment duration. Results：The mean relative changes of both treatments from baseline in urinary CTX, serum TRACP‒5b and urinary NTX were similar throughout the treatment duration. The values of those three resorption markers did not express any exceeded suppression. The suppression of urinary CTX levels rapidly expressed and reached to the maximum. Conclusions：Both oral and IV IBN treatments expressed the time‒course suppression of bone resorption markers without excess.