Zoledronate and Denosumab in Men With HIV on Antiretroviral Therapy

Osteoporosis drugs zoledronate (ZOL) and denosumab (Dmab) were safe and effective in an all-male study group of people living with HIV (PLWH) who were on antiretroviral therapy (ART). These findings, from an open-label, prospective, multicenter, cohort study, were published in Bone Reports.

The study group (n=23) comprised men who were on ART, met the threshold for needing osteoporosis treatment, and had not taken any osteoporosis drugs prior to the study. They were recruited at 2 hospitals in Greece between 2017 and 2018 and were randomized to receive a single 5 mg ZOL infusion (n=10) or biannual 60 mg subcutaneous Dmab injections (n=13). A control group of 14 age-matched men (also PLWH) with normal bone mineral density (BMD) were also recruited. All 3 groups were assessed for BMD at baseline and at 12 months.  

The ZOL, Dmab, and control group participants were aged mean 54.10±13.88, 58.31±9.77, and 50.29±6.59 years; had a mean body mass index (BMI) of 23.33±3.49, 24.61±4.82, and 25.46±2.67 kg/m²; and had been on ART for 10.75±7.19, 9.96±5.86, and 9.00±6.40 years, respectively.

During the 12 months of treatment, the ZOL group had a 7.23%±5.46% (P =.003) increase in femoral neck BMD and 5.43%±3.60% (P =.001) increase in vertebral BMD. The changes in the Dmab recipients were 3.01%±2.46% (P <.005) and 5.76%±3.44% (P <.005), respectively. The control group had a no significant increase to femoral neck BMD (P =.063) but a significant decrease in vertebral BMD (P =.044).

The change in BMD due to either treatment was similar for vertebral BMD but ZOL was associated with a more favorable femoral neck BMD increase (P <.05).

No new clinical fractures were reported during the study period. No transient acute phase response or reports of musculoskeletal pain 48 hours after infusion were reported in the ZOL group. No adverse events were recorded in the Dmab group, and no cases of osteonecrosis of the jaw or atypical femoral fracture were observed in the whole cohort.

Researchers acknowledged their findings were limited by the small number of participants and the observational nature of the study, and the exclusion of bone turnover marker measurements in order to more comprehensively assess drug efficacy.

“Both zoledronate and denosumab are efficient and well-tolerated therapeutic options that increase BMD, at least for the first year of treatment, and can be safely used in male PLWH under ART in order to prevent or, in most cases, reverse bone loss,” the researchers concluded, adding that randomized control trials with a longer follow-up period are needed.

Disclosure: Some study authors declared affiliations with pharmaceutical companies. Please see the original reference for a full list of authors’ disclosures.

Reference

Makras P, Petrikkos P, Anastasilakis, AD, , et al. Denosumab versus zoledronate for the treatment of low bone mineral density in male HIV-infected patients. Bone Rep. 2021;15:101128. doi:10.1016/j.bonr.2021.101128