title: Randomized trial comparing monthly ibandronate and weekly alendronate for osteoporosis in patients with primary biliary cirrhosis.
abstract: Osteoporosis resulting in bone fractures is a complication in patients with primary biliary cirrhosis (PBC). Once-weekly alendronate improves bone mass and is well tolerated in these patients, but there is a concern because of poor compliance. Therefore, the efficacy, adherence, and safety of monthly ibandronate (150 mg) with weekly alendronate (70 mg) were compared in a randomized, 2-year study in 42 postmenopausal women with PBC and osteoporosis. Bone mineral density (BMD) of the lumbar spine and proximal femur (by DXA), liver function, and bone markers were measured at entry and every 6 months over 2 years. Adherence to therapy was assessed by the Morisky-Green score. At enrollment, the two groups were similar with respect to age, BMD, severity of cholestasis, previous fractures, and bone markers. Thirty-three patients, 14 in the ibandronate group and 19 in the alendronate group, completed the trial. At 2 years both treatments resulted in a significant increase in BMD at the lumbar spine (from 0.875 ± 0.025 to 0.913 ± 0.026 g/cm(2), P < 0.001 with alendronate, and from 0.898 ± 0.024 to 0.949 ± 0.027 g/cm(2), P < 0.001 with ibandronate). The mean percentage change was 4.5% and 5.7%, respectively (P = not significant). BMD increased at the total hip by 2.0% and 1.2%, respectively. Changes in bone markers were similar in both groups and one patient with alendronate developed a new vertebral fracture. Adherence to therapy was higher with ibandronate (P = 0.009). Neither treatment impaired liver function or cholestasis.
  
  
  CONCLUSIONS
  Both regimens, weekly alendronate and monthly ibandronate, improve bone mass and are comparable in safety for osteoporosis therapy in patients with PBC, although adherence is higher with the monthly regimen. Further larger studies are needed to assess fracture prevention.
authors.affiliation: Metabolic Bone Diseases Unit, Service of Rheumatology, Hospital Clínic, IDIBAPS, University of Barcelona, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, CIBERehd, Barcelona, Spain.
authors.forename: Núria
authors.initials: N
authors.lastname: Guañabens
authors.forename: Anna
authors.initials: A
authors.lastname: Monegal
authors.forename: Dacia
authors.initials: D
authors.lastname: Cerdá
authors.forename: África
authors.initials: Á
authors.lastname: Muxí
authors.forename: Laia
authors.initials: L
authors.lastname: Gifre
authors.forename: Pilar
authors.initials: P
authors.lastname: Peris
authors.forename: Albert
authors.initials: A
authors.lastname: Parés
mesh_terms: D000284:Administration, Oral; D000368:Aged; D019386:Alendronate / Q000008:administration & dosage; D015519:Bone Density; D004164:Diphosphonates; D004334:Drug Administration Schedule; D005260:Female; D050723:Fractures, Bone / Q000517:prevention & control*; D006801:Humans; D000077557:Ibandronic Acid; D008105:Liver Cirrhosis, Biliary / Q000150:complications / Q000188:drug therapy*; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000150:complications / Q000188:drug therapy*; D010349:Patient Compliance; D016896:Treatment Outcome
chemical_list: D004164:Diphosphonates; D000077557:Ibandronic Acid; D019386:Alendronate