Comparison of bone mineral density changes between denosumab and bisphosphonates in tenofovir-exposed chronic hepatitis B patients with osteoporosis.

UNLABELLED: This study compared denosumab and bisphosphonates for osteoporosis in tenofovir-exposed chronic hepatitis B patients. Both denosumab and bisphosphonates increased bone mineral density (BMD) at year 1. However, denosumab resulted in a greater BMD improvement and a more pronounced reduction in procollagen type 1 N-terminal peptide (P1NP) compared to bisphosphonate. These findings suggest that while both drugs have beneficial effects, denosumab may be the more effective therapeutic option in this population.

BACKGROUND

Tenofovir disoproxil fumarate (TDF), a first-line antiviral for chronic hepatitis B (CHB), is a risk factor for osteoporosis. This study aimed to compare the effectiveness of denosumab and bisphosphonates for osteoporosis in TDF-exposed CHB patients.

METHODS

CHB patients who were treated with either denosumab or bisphosphonates for newly diagnosed osteoporosis during > 1 year of TDF treatment between 2010 and June 2024 were included from two tertiary centers in Korea. The primary outcome was bone mineral density (BMD) change at year 1 in the lumbar spine (LS) and femoral neck (FN). Secondary outcomes included changes in two bone turnover markers, procollagen type 1 N-terminal propeptide (P1NP) and C-telopeptide of type 1 collagen (CTX).

RESULTS

A total of 155 patients were included: 79 received denosumab and 76 received bisphosphonates. The median time from TDF initiation to osteoporosis diagnosis was 4.8 years. After balancing baseline characteristics using propensity score matching, the denosumab group showed a significant increase in BMD at the LS and FN (denosumab vs. bisphosphonates: LS, 11.7% vs. 6.4%, P = 0.001; FN, 4.9% vs. 1.7%, P = 0.008) at year 1. The denosumab group had a greater reduction in P1NP levels at 6 months (-72.7% vs. -63.8%, P = 0.001), with no significant difference in CTX changes (-70.8% vs. -71.4%, P = 0.74) compared to the bisphosphonates group. The inverse probability of treatment weighting analyses reproduced a similar trend.

CONCLUSIONS

In TDF-exposed CHB patients with osteoporosis, denosumab outperformed bisphosphonates in the LS and FN BMD at year 1. The reduction in P1NP level was also more prominent in the denosumab group.