吡格列酮对非酒精性脂肪性肝炎患者骨密度的影响:一项为期36个月的临床试验

Translated title of the contribution: Effect of pioglitazone on bone mineral density in patients with nonalcoholic steatohepatitis: A 36-month clinical trial

Paola Portillo-Sanchez, Fernando Bril, Romina Lomonaco, Diana Barb, Beverly Orsak, Jan Marie Bruder, Kenneth Cusi

Research output: Contribution to journalArticlepeer-review

7 Scopus citations

Abstract

Background: The effects of pioglitazone on bone metabolism are unclear. This study evaluated the long-term effects of pioglitazone on bone mineral density (BMD) and bone metabolism in patients with prediabetes or type 2 diabetes mellitus (T2DM) and non-alcoholic steatohepatitis (NASH). Methods: Ninety-two patients with prediabetes or T2DM and biopsy-proven NASH with BMD and baseline biochemical bone measurements were included. Patients (mean [±SEM] age 51 ± 1 years, 71% male, mean body mass index 34.5 ± 0.5 kg/m 2 ) were randomly assigned to pioglitazone (45 mg/day) or placebo for 18 months, followed by an 18-month open-label pioglitazone treatment phase. Baseline, 18- and 36-month evaluations included plasma vitamin D and bone turnover biomarker levels, and BMD measurements at the spine, femoral neck, total hip, and one-third radius. Results: After 18 months of pioglitazone treatment, there were no differences in BMD versus placebo at either the femoral neck (P =0.87), total hip (P =0.78), or one-third radius (P =0.44); however, bone density decreased at the level of the spine with pioglitazone (−3.5%; P =0.002). During the extension phase (18–36 months), patients had no further decreases in BMD or plasma biomarkers of bone turnover during pioglitazone treatment. No patient experienced a low-energy bone fracture. Conclusions: Treatment of patients with prediabetes or T2DM with pioglitazone for up to 3 years was associated with decreased BMD at the level of the lumbar spine. This reduction in BMD at the lumbar spine at 18 months versus placebo suggests an early deleterious effect of pioglitazone on bone metabolism.

Translated title of the contributionEffect of pioglitazone on bone mineral density in patients with nonalcoholic steatohepatitis: A 36-month clinical trial
Original languageChinese
Pages (from-to)223-231
Number of pages9
JournalJournal of Diabetes
Volume11
Issue number3
DOIs
StatePublished - Mar 2019

Keywords

  • bone metabolism
  • bone mineral density
  • diabetes mellitus
  • non-alcoholic fatty liver disease (NAFLD)
  • pioglitazone

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism

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