Utility of monthly minodronate for osteoporosis after gastrectomy: Prospective multicenter randomized controlled trials.

Aim: Osteoporosis in patients after gastrectomy is increasing with the aging of gastric cancer patients. Bisphosphonates are effective treatments for osteoporosis; however, their safety or efficacy in postgastrectomy patients has not been established. The purpose of this multicenter prospective intervention study was to investigate the impact of monthly minodronate on osteoporosis after gastrectomy.

Methods: Of the 261 enrolled gastric cancer patients, 164 patients were diagnosed with osteoporosis based on criteria of the Japan Society of Osteoporosis. They were randomly assigned 1:1 to groups treated with active vitamin D (VD group) or monthly minodronate (MIN group). The primary endpoint was changes in lumbar bone mineral density (L-BMD) 12 mo after the start of administration. The secondary endpoints were changes in bone metabolism markers, adverse events (AEs), or treatment completion rates.

Results: There was no significant difference in patient background between the VD (n = 82) and MIN (n = 82) groups. In the MIN group, the increase in L-BMD was significantly higher than that in the VD group (4.52% vs 1.72%,  = .001), with a significant reduction in bone metabolism markers; blood NTX (-25.6% vs -1.6%,  < .01) and serum bone-specific alkaline phosphatase (-34.3% vs -20.1%,  < .01). AEs were observed in 26.8% and 9.3% of the patients and treatment completion rates were 77.5% and 89.3% in the MIN and VD groups, respectively. Serious AEs were not observed in either group.

Conclusion: This study demonstrated the safety and efficacy of monthly minodronate, suggesting that this treatment may be useful for osteoporosis after gastrectomy (UMIN000015517).