A 4-year treatment with clodronate plus calcium and vitamin D supplements does not improve bone mass in primary biliary cirrhosis.
BACKGROUND
International guidelines for managing osteoporosis in cirrhosis or severe cholestasis indicate a <-2.5 t-score as a cut-off for medical treatment, while no treatment is recommended in the case of osteopenia (t-scores ranging from -1.0 to -2.5).


OBJECTIVE
We conducted a prospective study in primary biliary cirrhosis with a view to optimizing the rationale for the medical treatment of bone loss.


METHODS
All naïve post-menopausal women with primary biliary cirrhosis were enrolled in the study. Bone metabolism was evaluated by measuring 25-hydroxy-vitamin D, parathyroid hormone, osteocalcin. Bone mineral density was assessed at the lumbar spine by dual-photon X-ray absorptiometry at the baseline and every 2 years for up to 4 years. Patients with either osteopenia or osteoporosis received the following treatment: oral calcium carbonate (1000 mg/day)+vitamin D3 (880 IU/day)+i.m. disodium clodronate 100mg every 10 days for 4 years.


RESULTS
Ninety-six patients completed the study: 30 had a normal bone mineral density (group 1), 37 had osteopenia (group 2), 29 had osteoporosis (group 3). No significant differences in biochemical parameters of bone metabolism were observed between the three groups. A total of 288 bone mineral density measurements were taken. Linear regression analysis failed to reveal significant changes in t-score over the follow-up in all groups.


CONCLUSIONS
A 4-year treatment with clodronate+calcium/vitamin D3 supplements does not significantly improve osteoporosis or osteopenia in primary biliary cirrhosis women in menopause, but prevents the natural bone loss in these patients. Extensive international trials are warranted to optimize the prevention and treatment of bone loss in primary biliary cirrhosis.
Floreani
A
A
Department of Surgical and Gastroenterological Sciences, University of Padova, Padova, Italy. annarosa.floreani@unipd.it
Carderi
I
I
Ferrara
F
F
Rizzotto
E R
ER
Luisetto
G
G
Camozzi
V
V
Baldo
V
V
D000368:Aged; D015519:Bone Density / Q000187:drug effects*; D050071:Bone Density Conservation Agents / Q000627:therapeutic use; D001862:Bone Resorption / Q000150:complications / Q000188:drug therapy*; D002118:Calcium / Q000008:administration & dosage / Q000627:therapeutic use*; D004002:Clodronic Acid / Q000008:administration & dosage / Q000627:therapeutic use*; D019587:Dietary Supplements; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008105:Liver Cirrhosis, Biliary / Q000150:complications*; D008875:Middle Aged; D017211:Treatment Failure; D014807:Vitamin D / Q000008:administration & dosage / Q000627:therapeutic use*
D050071:Bone Density Conservation Agents; D004002:Clodronic Acid; D014807:Vitamin D; D002118:Calcium