Raloxifene improves bone mass in osteopenic women with primary biliary cirrhosis: Results of a pilot study

Cynthia Levy, Denise M. Harnois, Paul Angulo, Roberta Jorgensen, Keith Lindor

Research output: Contribution to journalArticle

51 Citations (Scopus)

Abstract

Background/Aims: Bone disease is common in patients with primary biliary cirrhosis (PBC). Our aim was to evaluate safety and efficacy of raloxifene in this population. Methods: Nine postmenopausal women with PBC were enrolled and seven completed the study. Subjects received raloxifene 60 mg daily for 1 year. Each patient on raloxifene was age-matched to three controls. Liver biochemistries were monitored periodically; bone mineral density (BMD) of the lumbar spine (LS) and femoral neck (FN) was measured at baseline and at 1 year. Results: No significant adverse effects were reported. Liver biochemistries remained unchanged. Baseline LS-BMD was similar in the treatment group and controls [median 0.720 g/cm2 (range 0.620-0.867) vs. 0.740 g/cm2 (0.570-1.040), P = 0.5]. Conclusion: Compared with baseline, LS-BMD improved significantly with 1 year of therapy [0.72 g/cm2 (0.62-0.87) vs. 0.74 g/cm2 (0.63-0.97), P = 0.02]. FN-BMD remained stable [0.53 g/cm2 (0.50-0.60) vs. 0.54 g/cm2 (0.49-0.63), P = 0.6]. Improvement in LS BMD was seen in patients on raloxifene but not in matched controls [0.02 g/cm2 (0.01-0.10) vs. 0.00 g/cm2 ( -0.120-0.040), P = 0.06)]. In conclusion, raloxifene appears safe and of benefit in preventing bone loss in patients with PBC. Larger studies with longer follow-up are warranted.

Original languageEnglish (US)
Pages (from-to)117-121
Number of pages5
JournalLiver International
Volume25
Issue number1
DOIs
StatePublished - Feb 2005
Externally publishedYes

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Biliary Liver Cirrhosis
Bone Density
Bone and Bones
Spine
Femur Neck
Biochemistry
Liver
Bone Diseases
Raloxifene Hydrochloride
Safety
Control Groups
Therapeutics
Population

Keywords

  • Bone disease
  • Clinical trial
  • Osteoporosis
  • Primary biliary cirrhosis
  • Therapy

ASJC Scopus subject areas

  • Hepatology

Cite this

Raloxifene improves bone mass in osteopenic women with primary biliary cirrhosis : Results of a pilot study. / Levy, Cynthia; Harnois, Denise M.; Angulo, Paul; Jorgensen, Roberta; Lindor, Keith.

In: Liver International, Vol. 25, No. 1, 02.2005, p. 117-121.

Research output: Contribution to journalArticle

Levy, Cynthia ; Harnois, Denise M. ; Angulo, Paul ; Jorgensen, Roberta ; Lindor, Keith. / Raloxifene improves bone mass in osteopenic women with primary biliary cirrhosis : Results of a pilot study. In: Liver International. 2005 ; Vol. 25, No. 1. pp. 117-121.
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abstract = "Background/Aims: Bone disease is common in patients with primary biliary cirrhosis (PBC). Our aim was to evaluate safety and efficacy of raloxifene in this population. Methods: Nine postmenopausal women with PBC were enrolled and seven completed the study. Subjects received raloxifene 60 mg daily for 1 year. Each patient on raloxifene was age-matched to three controls. Liver biochemistries were monitored periodically; bone mineral density (BMD) of the lumbar spine (LS) and femoral neck (FN) was measured at baseline and at 1 year. Results: No significant adverse effects were reported. Liver biochemistries remained unchanged. Baseline LS-BMD was similar in the treatment group and controls [median 0.720 g/cm2 (range 0.620-0.867) vs. 0.740 g/cm2 (0.570-1.040), P = 0.5]. Conclusion: Compared with baseline, LS-BMD improved significantly with 1 year of therapy [0.72 g/cm2 (0.62-0.87) vs. 0.74 g/cm2 (0.63-0.97), P = 0.02]. FN-BMD remained stable [0.53 g/cm2 (0.50-0.60) vs. 0.54 g/cm2 (0.49-0.63), P = 0.6]. Improvement in LS BMD was seen in patients on raloxifene but not in matched controls [0.02 g/cm2 (0.01-0.10) vs. 0.00 g/cm2 ( -0.120-0.040), P = 0.06)]. In conclusion, raloxifene appears safe and of benefit in preventing bone loss in patients with PBC. Larger studies with longer follow-up are warranted.",
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AB - Background/Aims: Bone disease is common in patients with primary biliary cirrhosis (PBC). Our aim was to evaluate safety and efficacy of raloxifene in this population. Methods: Nine postmenopausal women with PBC were enrolled and seven completed the study. Subjects received raloxifene 60 mg daily for 1 year. Each patient on raloxifene was age-matched to three controls. Liver biochemistries were monitored periodically; bone mineral density (BMD) of the lumbar spine (LS) and femoral neck (FN) was measured at baseline and at 1 year. Results: No significant adverse effects were reported. Liver biochemistries remained unchanged. Baseline LS-BMD was similar in the treatment group and controls [median 0.720 g/cm2 (range 0.620-0.867) vs. 0.740 g/cm2 (0.570-1.040), P = 0.5]. Conclusion: Compared with baseline, LS-BMD improved significantly with 1 year of therapy [0.72 g/cm2 (0.62-0.87) vs. 0.74 g/cm2 (0.63-0.97), P = 0.02]. FN-BMD remained stable [0.53 g/cm2 (0.50-0.60) vs. 0.54 g/cm2 (0.49-0.63), P = 0.6]. Improvement in LS BMD was seen in patients on raloxifene but not in matched controls [0.02 g/cm2 (0.01-0.10) vs. 0.00 g/cm2 ( -0.120-0.040), P = 0.06)]. In conclusion, raloxifene appears safe and of benefit in preventing bone loss in patients with PBC. Larger studies with longer follow-up are warranted.

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