Bisphosphonates prevents the bone mineral loss in lymphoma patients treated with glucocorticoids: a prospective, randomized controlled phase 3 trial in China
Background Glucocorticoids-containing regimens are the standard first line treatment for most lymphoma patients, however, as the improvement of overall survival in these cases, glucocorticoids related osteopenia or osteoporosis attracted attention in clinical administration. We aim to investigate the efficacy of bisphosphonates in prevention bone mineral loss in glucocorticoids-treated lymphoma patients. Methods This is a prospective, randomized controlled phase 3 trial. Eligible lymphoma
... from China with first line glucocorticoids involved treatment, were randomly assigned 1:1 to receive either Zoledronic acid (ZA) for twice infusion or not. All patients received daily oral calcium and vitamin D3 for one year. The primary endpoint, alternations of bone mineral loss from enrollment to the twelfth month at the lumbar spine (L1-L4), left hip and left femoral neck, measured by the dual-energy, x-ray absorptiometry scanners, recorded as T score; and new bone fractures during the first year, were analyzed by intent-to-treat. This trial was registered with www.Chictr.org, number ChiCTR-INR-17010771. Results Between May, 2016 to July, 2019, 84 patients were randomly assigned to both Zoledronic acid and control groups, 29 patients completed the study and were on follow-up. We found a marked improvement of T score in ZA group compared with the control in a year at lumbar spine, T score changes of L1-4 in ZA group and control group were as following: L1, 0.14±0.61 vs. -0.33±0.40, p=0.009; L2, 0.28±0.41 vs. -0.35±0.54, p=0.003; L3, 0.23±0.42 vs. -0.23±0.66, p=0.020; L4, 0.28±0.44 vs. -0.35±0.54, p=0.020. Meanwhile, no severe adverse event was observed on both groups. Conclusions Glucocorticoids-treatment lymphoma patients that prophylactic ZA infusion could relieve BMD loss to prevent osteoporosis without increasing severe adverse effects in Chinese population, providing reference for clinicians to consider ZA application in this situation.