Alendronate improves bone mineral density in primary biliary cirrhosis: a randomized placebo‐controlled trial
Open accessAbstract
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. (Hepatology 2005;42:762–771.)
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Alendronic acid is usually used first line if a bisphosphonate is required.
“If a bisphosphonate is required, alendronic acid is usually used first line.254–257”
From The British Society of Gastroenterology/UK-PBC primary biliary cholangitis treatment and management guidelines (2018) · cites this paper as [255]
The Discussion (pp. 762–771) concludes that alendronate increased bone mineral density in patients with PBC-related bone loss. It does not say that alendronic acid is usually the first-line bisphosphonate; the trial compared it with placebo, not with other bisphosphonates. (LLM, conf=0.79)
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References 54 · Cited by 142
Research works printed but not linked: 3
- Atkinson M, Nordin BE, Sherlock S. Bone disease in obstructive jaundice. Q J Med 1956;25:299-312.
- Bauer DC, Black D, Ensrud K, Thompson D, Hochberg M, Nevitt M, Musliner T, et al. Upper gastrointestinal tract safety profile of alendronate. Arch Intern Med 2000;160:517-525.
- Lieverse RJ. Hepatitis after alendronate. Neth J Med 1998;53:271-272.
- Authors
- Zein, C. O., Jorgensen, R. A., Clarke, B., Wenger, D. E., Keach, J. C., Angulo, P., & Lindor, K. D.
- Affiliations
- Mayo Clinic (US)
- Corresponding author
- Lindor, Keith D.
- Venue
- Hepatology
- Published
- 2005-10
- Volume
- 42
- Issue
- 4
- Pages
- 762-771
- ISSN
- 0270-9139 (ISSN-L)
- OpenAlex
- W2050708978
- Cited by
- 142
- References
- 54
- Citations by year
- 2026: 1 · 2025: 2 · 2024: 1 · 2023: 3 · 2022: 2 · 2021: 4 · 2020: 5 · 2019: 6 · 2018: 11 · 2017: 8 · 2016: 7 · 2015: 7 · 2014: 12 · 2013: 7 · 2012: 14
- FWCI
- 6.75
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Hepatology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Orthopedics and Sports Medicine › Bone health and osteoporosis research
- Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
- Health Sciences › Medicine › Oncology › Bone health and treatments
- Keywords
- alendronate, primary biliary cirrhosis, bone mineral density, bone loss, bisphosphonates, bone turnover markers, lumbar spine, proximal femur, estrogen therapy, drug safety
- MeSH terms
- Aged, Estrogens, Female, Femur, Humans, Liver Cirrhosis, Biliary, Lumbar Vertebrae, Male, Middle Aged, Placebos, Biomarkers, Bone Density, Estrogen Replacement Therapy, Spinal Fractures, Treatment Outcome, Alendronate
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