Denosumab versus zoledronate for the treatment of low bone mineral density in male HIV-infected patients.

Introduction: We aimed to compare annual changes in the bone mineral density (BMD) at the lumbar spine (LS) and the femoral neck (FN) in males with HIV-associated osteoporosis treated with either zoledronate (ZOL) or denosumab (Dmab).
Methods: In this open label, 12-month, prospective, multicenter, cohort study, 23 male people living with HIV (PLWH) under antiretroviral therapy (ART) with low BMD were administered either a single iv infusion of ZOL 5 mg ( n  = 10) or Dmab 60 mg sc injections biannually ( n  = 13). Fourteen age-matched male PLWH with normal BMD served as controls. BMD was measured at baseline and at 12 months.
Results: LS-BMD increased within both treatment groups at 12 months (ZOL 5.43% ± 3.60%, p  = 0.001; Dmab 5.76% ± 3.44%, p  < 0.005) and decreased in controls (-2.58% ± 4.12, p  = 0.04). FN-BMD increased in both treatment groups at 12 months (ZOL 7.23% ± 5.46%, p  = 0.003; Dmab 3.01% ± 2.46%, p  < 0.005), and remained unchanged in controls (1.22% ± 2.09, p  = 0.06). LS-BMD changes did not differ between the two treatment groups, but FN-BMD changes were more prominent in the ZOL group ( p  < 0.05). None of our study cohort sustained new fragility fractures during the 12-month study period, and no case of acute phase response was recorded in the ZOL group.
Conclusions: In male PLWH under ART requiring osteoporosis treatment both ZOL and Dmab are efficient and well tolerated therapeutic options achieving BMD increases at least for the first year of treatment.
Competing Interests: P. Makras reports honoraria for lectures and research grants from Amgen and Gilead; A.D. Anastasilakis reports lecture fees from Amgen; P. Petrikkos, A. Kolynou, A. Katsarou, O. Tsachouridou, S. Metallidis, and M.P. Yavropoulou have nothing to declare.
(© 2021 The Authors.)