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A 4-year treatment with clodronate plus calcium and vitamin D supplements does not improve bone mass in primary biliary cirrhosis.
Dig Liver Dis 2007; 39(6):544-8DL

Abstract

INTRODUCTION

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).

AIM

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.

Authors+Show Affiliations

Department of Surgical and Gastroenterological Sciences, University of Padova, Padova, Italy. annarosa.floreani@unipd.itNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article

Language

eng

PubMed ID

17416215

Citation

Floreani, A, et al. "A 4-year Treatment With Clodronate Plus Calcium and Vitamin D Supplements Does Not Improve Bone Mass in Primary Biliary Cirrhosis." Digestive and Liver Disease : Official Journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver, vol. 39, no. 6, 2007, pp. 544-8.
Floreani A, Carderi I, Ferrara F, et al. A 4-year treatment with clodronate plus calcium and vitamin D supplements does not improve bone mass in primary biliary cirrhosis. Dig Liver Dis. 2007;39(6):544-8.
Floreani, A., Carderi, I., Ferrara, F., Rizzotto, E. R., Luisetto, G., Camozzi, V., & Baldo, V. (2007). A 4-year treatment with clodronate plus calcium and vitamin D supplements does not improve bone mass in primary biliary cirrhosis. Digestive and Liver Disease : Official Journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver, 39(6), pp. 544-8.
Floreani A, et al. A 4-year Treatment With Clodronate Plus Calcium and Vitamin D Supplements Does Not Improve Bone Mass in Primary Biliary Cirrhosis. Dig Liver Dis. 2007;39(6):544-8. PubMed PMID: 17416215.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A 4-year treatment with clodronate plus calcium and vitamin D supplements does not improve bone mass in primary biliary cirrhosis. AU - Floreani,A, AU - Carderi,I, AU - Ferrara,F, AU - Rizzotto,E R, AU - Luisetto,G, AU - Camozzi,V, AU - Baldo,V, Y1 - 2007/04/06/ PY - 2006/09/12/received PY - 2007/02/08/revised PY - 2007/02/12/accepted PY - 2007/4/10/pubmed PY - 2007/8/19/medline PY - 2007/4/10/entrez SP - 544 EP - 8 JF - Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver JO - Dig Liver Dis VL - 39 IS - 6 N2 - INTRODUCTION: 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). AIM: 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. SN - 1590-8658 UR - https://www.unboundmedicine.com/medline/citation/17416215/A_4_year_treatment_with_clodronate_plus_calcium_and_vitamin_D_supplements_does_not_improve_bone_mass_in_primary_biliary_cirrhosis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1590-8658(07)00060-6 DB - PRIME DP - Unbound Medicine ER -