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Comparative Study
. 2025 Aug;36(8):1391-1403.
doi: 10.1007/s00198-025-07602-1. Epub 2025 Jul 11.

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

Yunmi Ko #  1 , Byeong Geun Song #  2 , Hyunjae Shin  1 , Youngsu Park  1 , Jeayeon Park  1 , Min Kyung Park  1 , Yun Bin Lee  1 , Su Jong Yu  1 , Dong Hyun Sinn  2 , Yoon Jun Kim  1 , Jung-Hwan Yoon  1 , Seung Shin Park #  3 , Moon Haeng Hur #  4 , Jeong-Hoon Lee #  5
Affiliations
Comparative Study

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

Yunmi Ko et al. Osteoporos Int. 2025 Aug.

Erratum in

Abstract

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.

Keywords: Antiresorptive agents; Chronic hepatitis B; Osteoporosis; Tenofovir disoproxil fumarate.

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Conflict of interest statement

Declarations. Ethical approval: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent: For this type of study formal consent is not required. Conflict of interest: Yunmi Ko: Nothing to declare; Byeong Geun Song: Nothing to declare; Hyunjae Shin: Nothing to declare; Youngsu Park: Nothing to declare; Jeayeon Park: Nothing to declare; Min Kyung Park: Nothing to declare; Yun Bin Lee: Receives research grants from Samjin Pharmaceuticals and Yuhan Pharmaceuticals; Su Jong Yu: Receives research grants from Yuhan Pharmaceuticals and Daewoong Pharmaceuticals; Dong Hyun Sinn: Nothing to declare; Yoon Jun Kim: Receives research grants from Roche, JW Creagene, Bukwang Pharmaceutical, Handok Pharmaceuticals, Hanmi, Bristol Myers Squibb, Yuhan Pharmaceuticals, and PharmaKing, and lecture fees from Bayer, Gilead Sciences, MSD, Yuhan Pharmaceuticals, Samil Pharmaceuticals, CJ Pharmaceuticals, Bukwang Pharmaceutical, and Handok Pharmaceuticals; Jung-Hwan Yoon: Receives research grants from Bayer, Daewoong Pharmaceutical, and Bukwang Pharmaceutical; Seung-Shin Park: Nothing to declare; Moon Haeng Hur: Nothing to declare; Jeong-Hoon Lee: Receives research grants from Yuhan Pharmaceuticals and GreenCross Cell, lecture fees from GreenCross Cell, Daewoong Pharmaceuticals, and Gilead Korea.

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