Osteoporosis in Primary Biliary Cirrhosis: A Randomized Trial of the Efficacy and Feasibility of Estrogen/Progestin
Abstract
The optimal therapy for the prevention and treatment of osteoporosis in primary biliary cirrhosis (PBC) is unknown. Hormone replacement therapy (HRT) prevents osteoporosis, but may promote cholestasis. We performed a double-blind, randomized, placebo-controlled trial of transdermal estrogen/progestin in postmenopausal women with PBC. The 24-month study enrolled 31 patients, but trial uptake was limited and treatment arm dropout was significant. Placebo-treated patients had a higher percentage loss in femoral neck bone mineral density than actively treated patients (-3.76 +/- 1.37% versus 0.21 +/- 1.01%, respectively, P = .058). New fractures occurred in 2 patients on placebo, and in no patients on treatment. The mean monthly increase in bilirubin was not significantly different between groups, but individual data suggest HRT may worsen cholestasis. In conclusion, women with PBC have strong feelings about HRT, and recruitment for this intervention is difficult. Transdermal estrogen/progestin likely provides protection against bone loss in PBC patients, but may worsen cholestasis.
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Hormone replacement therapy improves bone mineral density somewhat in PBC, but safety concerns limit its use.
“Hormone replacement therapy has led to some improvement in bone mineral density, but these agents are seldom used because of safety concerns.(243)”
From Primary Biliary Cholangitis: 2018 Practice Guidance from the American Association for the Study of Liver Diseases (2019) · cites this paper as [243]
There are limited data regarding the use of hormone replacement therapy and its efficacy in osteoporosis prevention in PBC.
“There are limited data regarding the use of hormone replacement therapy and its efficacy in osteoporosis prevention in PBC.258 259”
From The British Society of Gastroenterology/UK-PBC primary biliary cholangitis treatment and management guidelines (2018) · cites this paper as [259]
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References 59 · Cited by 54
- Authors
- Boone, R. H., Cheung, A. M., Girlan, L. M., & Heathcote, E. J.
- Affiliations
- University of Toronto (CA)
- University Health Network (CA)
- ORCID
- Cheung, Angela M.
- Venue
- Digestive Diseases and Sciences
- Published
- 2006-06
- Volume
- 51
- Issue
- 6
- Pages
- 1103-1112
- ISSN
- 0163-2116 (ISSN-L)
- 1573-2568
- OpenAlex
- W1994221145
- Cited by
- 54
- References
- 59
- Citations by year
- 2026: 1 · 2025: 3 · 2023: 1 · 2022: 3 · 2021: 2 · 2020: 2 · 2019: 3 · 2018: 6 · 2017: 2 · 2016: 2 · 2014: 1 · 2013: 4 · 2012: 4
- FWCI
- 2.72
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- www.springer.com/tdm (tdm)
- Locations
- Digestive Diseases and Sciences (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Canadian Institutes of Health Research (44917)
- Topics
- Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
- Health Sciences › Medicine › Orthopedics and Sports Medicine › Bone health and osteoporosis research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
- Keywords
- primary biliary cirrhosis, osteoporosis, estrogen-progestin, hormone replacement therapy, transdermal estrogen, bone mineral density, femoral neck, postmenopausal women, cholestasis, fracture prevention, trial recruitment
- MeSH terms
- Norethindrone Acetate, Administration, Cutaneous, Bilirubin, Double-Blind Method, Estradiol, Female, Humans, Liver Cirrhosis, Biliary, Middle Aged, Norethindrone, Bone Density, Osteoporosis, Postmenopausal, Estrogen Replacement Therapy, Treatment Outcome
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