Alendronate improves bone mineral density in primary biliary cirrhosis: A randomized placebo-controlled trial

Claudia O. Zein, Roberta A. Jorgensen, Bart Clarke, Doris E. Wenger, Jill C. Keach, Paul Angulo, Keith Lindor

Research output: Contribution to journalArticle

103 Citations (Scopus)

Abstract

Bone loss is a well-recognized complication of primary biliary cirrhosis (PBC). Although it has been suggested that alendronate might improve bone mineral density (BMD) in PBC, no randomized placebo-controlled trial has been conducted. The primary aim of this study was to compare the effects of alendronate versus placebo on BMD and biochemical measurements of bone turnover in patients with PBC-associated bone loss. We conducted a double-blinded, randomized, placebo-controlled trial. Patients with a PBC and BMD t score of less than -1.5 were randomized to receive 70 mg per week of alendronate or placebo over 1 year. BMD of the lumbar spine and proximal femur were measured at entry and at 1 year. Changes from baseline in BMD and biochemical measurements of bone turnover were assessed. Thirty-four patients were enrolled. Seventeen patients were randomized to each arm. After 1 year, a significantly larger improvement (P = .005) in spine BMD was observed in the alendronate group (0.09 ± 0.03 g/cm2 SD from baseline) compared with the placebo group (-0.003 ± 0.02 g/cm2 SD from baseline). A larger improvement (P = .046) was also observed in the femoral BMD of alendronate patients versus placebo. BMD changes were independent of concomitant estrogen therapy. The rate of adverse effects was similar in both groups. In conclusion, in patients with PBC-related bone loss, alendronate significantly improves BMD compared with placebo. Although in this study oral alendronate appears to be well tolerated in patients with PBC, larger studies are needed to formally evaluate safety.

Original languageEnglish (US)
Pages (from-to)762-771
Number of pages10
JournalHepatology
Volume42
Issue number4
DOIs
StatePublished - Oct 2005
Externally publishedYes

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Alendronate
Biliary Liver Cirrhosis
Bone Density
Randomized Controlled Trials
Placebos
Bone Remodeling
Bone and Bones
Spine
Thigh
Femur
Estrogens
Safety

ASJC Scopus subject areas

  • Hepatology

Cite this

Zein, C. O., Jorgensen, R. A., Clarke, B., Wenger, D. E., Keach, J. C., Angulo, P., & Lindor, K. (2005). Alendronate improves bone mineral density in primary biliary cirrhosis: A randomized placebo-controlled trial. Hepatology, 42(4), 762-771. https://doi.org/10.1002/hep.20866

Alendronate improves bone mineral density in primary biliary cirrhosis : A randomized placebo-controlled trial. / Zein, Claudia O.; Jorgensen, Roberta A.; Clarke, Bart; Wenger, Doris E.; Keach, Jill C.; Angulo, Paul; Lindor, Keith.

In: Hepatology, Vol. 42, No. 4, 10.2005, p. 762-771.

Research output: Contribution to journalArticle

Zein, CO, Jorgensen, RA, Clarke, B, Wenger, DE, Keach, JC, Angulo, P & Lindor, K 2005, 'Alendronate improves bone mineral density in primary biliary cirrhosis: A randomized placebo-controlled trial', Hepatology, vol. 42, no. 4, pp. 762-771. https://doi.org/10.1002/hep.20866
Zein, Claudia O. ; Jorgensen, Roberta A. ; Clarke, Bart ; Wenger, Doris E. ; Keach, Jill C. ; Angulo, Paul ; Lindor, Keith. / Alendronate improves bone mineral density in primary biliary cirrhosis : A randomized placebo-controlled trial. In: Hepatology. 2005 ; Vol. 42, No. 4. pp. 762-771.
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