{
  "abstract": "Patients with PBC have higher risk of osteoporosis and fractures. Risk of fracture is noted for peroxisome proliferator-activated receptor agonists. We present bone mineral density (BMD) and bone serum biomarkers assessed to Week 52 in the phase III ELATIVE® trial ( NCT04526665).Patients (N=161) were randomized 2:1 to elafibranor 80 mg or placebo. Bone fracture frequency was assessed. BMD was assessed by dual energy X-ray absorptiometry (DEXA) scan (reported as T scores). Bone turnover was assessed via two serum biomarkers: carboxy terminal crosslinked telopeptides of type 1 collagen (CTX, bone resorption marker) and type 1 procollagen peptide (P1NP, bone formation marker). Changes from baseline (CfB) in BMD T scores and CTX and P1NP levels were assessed to Week 52.In total, 63, 64, and 59 patients receiving elafibranor and 27, 26, and 24 receiving placebo had baseline and Week 52 BMD T scores for the femoral neck, lumbar, and total hip regions, respectively. Distribution of BMD T scores at baseline suggested osteopenia and osteoporosis in both groups, particularly in patients who received elafibranor. Imbalances were also seen in the underlying medical history for osteoporosis (elafibranor, 19.4%; placebo, 3.8%) and osteopenia (elafibranor: 19.4%; placebo: 17.0%) for the overall trial population. No significant differences were seen in CfB of mean BMD T scores in the femoral neck and lumbar spine regions. A significant difference in CfB of BMD T scores in the total hip regions was seen between the elafibranor and placebo groups (least squares mean [LSM]: elafibranor, 0.020; placebo, −0.305; p=0.0186). Overall, 81 patients receiving elafibranor and 32 receiving placebo had baseline and Week 52 CTX and P1NP data. An increase in CTX and a decrease in P1NP was observed in both groups; no meaningful between-group differences were reported. Increased CTX with elafibranor was numerically smaller than with placebo (LSM difference vs placebo: −11.0 pg/mL [95% confidence interval (CI) −91.3, 69.3]; p=0.787). Decreased P1NP with elafibranor was numerically smaller than with placebo (LSM difference vs placebo: 3.5 μg/L [95% CI −6.7; 13.7]; p=0.495). Seven (6.4%) patients receiving elafibranor and none receiving placebo had bone fractures. Six of the patients with bone fractures had an associated accidental fall and all had a confounding medical history.Biomarkers of bone turnover and fracture rates in patients with PBC receiving elafibranor or placebo suggest that elafibranor has no negative impact on bone health. Elafibranor’s efficacy and safety profile favours its use in the treatment of PBC.",
  "authors": [
    {
      "affiliations": [
        "Department of Internal Medicine II, Saarland University Medical Center, Homburg, Germany, Homburg , Germany"
      ],
      "name": "Jörn M Schattenberg"
    },
    {
      "affiliations": [
        "Medicina Interna Metabolica, Baggiovara Hospital, Azienda Ospedaliero-Universitaria di Modena and Università di Modena e Reggio Emilia, Modena, Italy, Modena , Italy"
      ],
      "name": "Pietro Andreone"
    },
    {
      "affiliations": [
        "Institute of Liver Studies, King’s College Hospital NHS Foundation Trust, London, UK, London, UK"
      ],
      "name": "Michael A Heneghan"
    },
    {
      "affiliations": [
        "Division of Digestive Health and Liver Diseases, University of Miami School of Medicine, Miami, FL, USA, Miami , USA",
        "Schiff Center for Liver Diseases, University of Miami, Miami, FL, USA, Miami , USA"
      ],
      "name": "Cynthia Levy"
    },
    {
      "affiliations": [
        "Ipsen, Cambridge, MA, USA, Cambridge, USA"
      ],
      "name": "Nuno Antunes"
    },
    {
      "affiliations": [
        "Ipsen, London, UK, London , UK"
      ],
      "name": "Darren Asquith"
    },
    {
      "affiliations": [
        "Ipsen, Paris, France, Paris, France"
      ],
      "name": "Valeria Cranham"
    },
    {
      "affiliations": [
        "Ipsen, Paris, France, Paris, France"
      ],
      "name": "Hugo Gomes da Silva"
    },
    {
      "affiliations": [
        "Ipsen, London, UK, London , UK"
      ],
      "name": "Amandeep Phagura"
    },
    {
      "affiliations": [
        "Division of Digestive and Liver Diseases, University of Texas Southwestern Medical Center, Dallas, TX, USA, Dallas, USA"
      ],
      "name": "Marlyn J Mayo"
    }
  ],
  "title": "P30 Treatment with elafibranor has no impact on bone health in patients with primary biliary cholangitis (PBC)",
  "uid": "e5c1fe2f-4e94-5382-94f3-f2ccae7485f3"
}