Two-year risedronate treatment for osteoporosis in patients with esophageal varices: a non-randomized clinical trial

Hepatol Int. 2022 Dec;16(6):1458-1467. doi: 10.1007/s12072-022-10366-z. Epub 2022 Jun 29.

Abstract

Background: Bisphosphonates are the mainstay of osteoporosis treatment, but their use for patients with esophageal varices has been avoided due to the risk of esophagitis, which may cause variceal bleeding. Since most clinical trials assessing osteoporosis treatment last 2-3 years, this study aimed to evaluate a 2-year risedronate treatment for patients with esophageal varices and liver cirrhosis.

Methods: The study received Institutional Review Board approval, and the sample was divided into two groups according to bone mineral density (BMD). Cirrhosis severity and endoscopic findings at baseline were similar between the groups. The intervention group had 51 patients with osteoporosis, who received oral risedronate 35 mg weekly plus calcium and vitamin D supplements. The control group had 51 patients with osteopenia, receiving only the supplements. Scheduled esophagogastroduodenoscopies and BMD measurements were carried out.

Results: The adjusted esophagitis risk was higher in the intervention group; however, none of the subjects had digestive bleeding. Lumbar spine BMD increased in the intervention group (- 3.06 ± 0.71 to - 2.33 ± 0.90; p < 0.001) and in the control group (- 1.38 ± 0.77 to - 1.10 ± 1.05; p = 0.012). Femoral neck BMD did not change in the intervention group (- 1.64 ± 0.91 to - 1.71 ± 0.95; p = 0.220), but tended to decrease in the control group (- 1.00 ± 0.74 to - 1.09 ± 0.82; p = 0.053).

Conclusion: Oral risedronate was effective and did not cause gastrointestinal bleeding in cirrhotic patients with esophageal varices under endoscopic surveillance.

Keywords: Bisphosphonates; Bone mineral density; Cirrhosis; Dual-energy X-ray absorptiometry; Endoscopy; Esophageal varices; Esophagitis; Gastrointestinal hemorrhage; Osteopenia; Osteoporosis.

Publication types

  • Clinical Trial

MeSH terms

  • Bone Density
  • Bone Density Conservation Agents* / adverse effects
  • Bone Density Conservation Agents* / therapeutic use
  • Esophageal and Gastric Varices* / complications
  • Esophagitis* / chemically induced
  • Esophagitis* / complications
  • Esophagitis* / drug therapy
  • Gastrointestinal Hemorrhage / complications
  • Humans
  • Liver Cirrhosis / complications
  • Liver Cirrhosis / drug therapy
  • Osteoporosis* / chemically induced
  • Osteoporosis* / complications
  • Osteoporosis* / drug therapy
  • Risedronic Acid / therapeutic use

Substances

  • Risedronic Acid
  • Bone Density Conservation Agents