Raloxifene improves bone mass in osteopenic women with primary biliary cirrhosis: results of a pilot study.
OBJECTIVE
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/cm(2) (range 0.620-0.867) vs. 0.740 g/cm(2) (0.570-1.040), P=0.5].


CONCLUSIONS
Compared with baseline, LS-BMD improved significantly with 1 year of therapy [0.72 g/cm(2) (0.62-0.87) vs. 0.74 g/cm(2) (0.63-0.97), P=0.02]. FN-BMD remained stable [0.53 g/cm(2) (0.50-0.60) vs. 0.54 g/cm(2) (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/cm(2) (0.01-0.10) vs. 0.00 g/cm(2) (-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.
Levy
Cynthia
C
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN 55905, USA.
Harnois
Denise M
DM
Angulo
Paul
P
Jorgensen
Roberta
R
Lindor
Keith D
KD
D000284:Administration, Oral; D000368:Aged; D015519:Bone Density / Q000187:drug effects; D005260:Female; D005272:Femur Neck / Q000187:drug effects / Q000378:metabolism; D006801:Humans; D008099:Liver / Q000187:drug effects / Q000378:metabolism; D008105:Liver Cirrhosis, Biliary / Q000150:complications / Q000188:drug therapy* / Q000378:metabolism; D008159:Lumbar Vertebrae / Q000187:drug effects / Q000378:metabolism; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy* / Q000209:etiology / Q000378:metabolism; D010865:Pilot Projects; D020849:Raloxifene Hydrochloride / Q000627:therapeutic use*; D020845:Selective Estrogen Receptor Modulators / Q000627:therapeutic use*; D016896:Treatment Outcome
D020845:Selective Estrogen Receptor Modulators; D020849:Raloxifene Hydrochloride