A new study published in Hepatology Communications suggests that denosumab may be a safe and effective alternative to zoledronic acid for treating osteoporosis in people with primary biliary cholangitis (PBC).
The multicenter randomized trial compared the two drugs in Japanese patients with PBC and untreated osteoporosis over 12 months. Researchers found that denosumab increased bone mineral density in the lumbar spine nearly as well as zoledronic acid, a standard treatment, and was associated with fewer side effects.
Osteoporosis is a frequent and debilitating complication of PBC, affecting up to half of patients and raising the risk of fractures. Bisphosphonates such as zoledronic acid are standard treatments but can cause flu-like reactions and may be unsuitable for people with kidney impairment.
Denosumab, a monoclonal antibody given as a twice-yearly injection, inhibits bone resorption by blocking the RANKL pathway, and may be easier for some patients to tolerate.
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The study involved 47 participants, who each received either subcutaneous denosumab every six months or intravenous zoledronic acid once yearly. All patients took a daily vitamin D supplement.
After 12 months, both groups showed improvements in bone density. At the spine, bone mineral density increased by about 7.5% with denosumab and 6.4% with zoledronic acid, meeting the study’s criteria for non-inferiority. At the hip, gains were 5.0% with denosumab and 2.6% with zoledronic acid, a difference that narrowly missed the statistical threshold for non-inferiority.
However, adverse events occurred in only 14% of denosumab recipients compared with 50% of those given zoledronic acid; the main side effect in the zoledronic acid group was a temporary flu-like reaction. No serious complications, such as osteonecrosis of the jaw, were seen in either group.
The study has important limitations, including its relatively small sample size that was only and followed for a year, so it can’t yet show whether denosumab reduces fractures or remains safe long-term. Still, the results are encouraging for people with PBC who need treatment for osteoporosis but may not tolerate bisphosphonates well. The study’s authors call for larger, longer studies to confirm these early findings.
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