Trial reportHepatology communications2025
Denosumab versus zoledronic acid for osteoporosis treatment in patients with primary biliary cholangitis (the DELTA Study): A multicenter, non-inferiority randomized trial.
Trial report in Hepatology communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed.
- The liver-bone axis: an emerging player in disease pathogenesis and therapeutic intervention.Science China. Life sciences · 2026Review
- Current Treatment of Primary Biliary Cholangitis and Primary Sclerosing Cholangitis: A Comprehensive Review.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2026Review
- Osteoporosis in primary biliary cholangitis: from cholestasis to fracture prevention.Clinical and experimental hepatology · 2026Review
- Primary Biliary Cholangitis-associated Osteoporosis: Contemporary Review of Pathogenesis and Management.Journal of clinical and translational hepatology · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
22 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOsteoporosis is a common complication in patients with primary biliary cholangitis (PBC). This study aimed to compare the efficacy and safety of denosumab and zoledronic acid (ZOL) in treating osteoporosis in PBC patients.
methodsThis multicenter, randomized, open-label trial enrolled Japanese patients with PBC and osteoporosis. Patients were randomized to receive either subcutaneous denosumab 60 mg every 6 months (denosumab group) or i.v. zoledronic acid 5 mg yearly (ZOL group). The primary endpoint was the mean percent change in bone mineral density (BMD) at the lumbar spine and total hip from baseline to 12 months.
resultsOf 47 enrolled patients, 41 (87.2%) completed the study (denosumab: n=21; ZOL: n=20). At 12 months, lumbar spine BMD increased by 7.5% in the denosumab group and 6.4% in the ZOL group, demonstrating the non-inferiority of denosumab (95% CI: -1.6% to 3.8%). Although the total hip BMD increased more in the denosumab group than in the ZOL group (5.0% vs. 2.6%, p<0.01), the difference did not meet the predefined non-inferiority margin (95% CI: -1.3% to 6.2%). Serum ALP to upper limit of normal ratio and bone turnover markers significantly decreased in both groups; however, the rates of change were not significantly different between them. The incidence of adverse events was significantly lower in the denosumab group compared with the ZOL group (14.3% vs. 50.0%, p=0.013).
conclusionsDenosumab is a safe and effective treatment option for osteoporosis in patients with PBC.
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Registered trials
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