title: Comparison of two different strategies of treatment with zoledronate in HIV-infected patients with low bone mineral density: single dose versus two doses in 2 years.
abstract: OBJECTIVE
  Given the need for easily managed treatment of osteoporosis in HIV-infected patients, we evaluated the efficacy and tolerability of two doses of zoledronate, by comparing three groups of patients: those with annual administration, those with biennial administration (one dose in 2 years) and a control group with no administration of zoledronate.
  
  
  METHODS
  We randomized (2:1) 31 patients on antiretroviral therapy with low bone mineral density (BMD) to zoledronate (5 mg administered intravenously; 21 patients) plus diet counselling and to a control group (diet counselling; 10 patients). At week 48, patients treated with zoledronate were randomized again to receive a second dose (two-dose group; n = 12) or to continue with diet counselling only (single-dose group; n = 9). Changes in lumbar spine and hip BMD and bone turnover markers were compared.
  
  
  RESULTS
  The median percentage change from baseline to week 96 in L1-L4 BMD was -1.74% [interquartile range (IQR) -2.56, 3.60%], 7.90% (IQR 4.20, 16.57%) and 5.22% (IQR 2.02, 7.28%) in the control, two-dose and single-dose groups, respectively (P < 0.01, control vs. two doses; P = 0.02, control vs. single dose; P = 0.18, two doses vs. single dose). Hip BMD changed by a median of 2.12% (IQR -0.12, 3.08%), 5.16% (IQR 3.06, 6.74%) and 4.47% (IQR 1, 5.58%), respectively (P = 0.04, control vs. two doses; P = 0.34, two doses vs. single dose). No differences between the two-dose and single-dose groups were detected in bone markers at week 96.
  
  
  CONCLUSIONS
  The benefits for BMD of a single dose of zoledronate in 2 years may be comparable to those obtained with two doses of the drug after 96 weeks, although this study is insufficiently powered to exclude a real difference. Future studies should explore whether biennial administration of zoledronate is a useful alternative in the treatment of osteoporosis in HIV-infected patients.
authors.affiliation: Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain.|Universitat Autònoma de Barcelona, Badalona, Spain.|Universitat de Vic-Universitat central de Catalunya, Spain.
authors.forename: E
authors.initials: E
authors.lastname: Negredo
authors.affiliation: Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain.|Universitat Autònoma de Barcelona, Badalona, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Bonjoch
authors.affiliation: Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain.|Universitat Autònoma de Barcelona, Badalona, Spain.|Statistics and Operations Research Department, Universitat Politècnica de Catalunya, Barcelona, Spain.
authors.forename: N
authors.initials: N
authors.lastname: Pérez-Álvarez
authors.affiliation: Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain.|Universitat Autònoma de Barcelona, Badalona, Spain.|Department of Econometrics, University of Barcelona, Barcelona, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Ornelas
authors.affiliation: Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain.|Universitat Autònoma de Barcelona, Badalona, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Puig
authors.affiliation: Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain.|Universitat Autònoma de Barcelona, Badalona, Spain.
authors.forename: C
authors.initials: C
authors.lastname: Herrero
authors.affiliation: Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain.|Universitat Autònoma de Barcelona, Badalona, Spain.
authors.forename: C
authors.initials: C
authors.lastname: Estany
authors.affiliation: CETIR Centre Mèdic, Barcelona, Spain.
authors.forename: L
authors.initials: L
authors.lastname: del Río
authors.affiliation: CETIR Centre Mèdic, Barcelona, Spain.
authors.forename: S
authors.initials: S
authors.lastname: di Gregorio
authors.affiliation: Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain.|Universitat Autònoma de Barcelona, Badalona, Spain.
authors.forename: P
authors.initials: P
authors.lastname: Echeverría
authors.affiliation: Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain.|Universitat Autònoma de Barcelona, Badalona, Spain.|Universitat de Vic-Universitat central de Catalunya, Spain.|Irsicaixa Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain.
authors.forename: B
authors.initials: B
authors.lastname: Clotet
mesh_terms: D015502:Absorptiometry, Photon; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects*; D015415:Biomarkers / Q000097:blood; D015519:Bone Density / Q000187:drug effects*; D050071:Bone Density Conservation Agents / Q000008:administration & dosage*; D016723:Bone Remodeling / Q000187:drug effects; D004164:Diphosphonates / Q000008:administration & dosage*; D037001:Directive Counseling; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005247:Feeding Behavior; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage*; D008159:Lumbar Vertebrae / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000139:chemically induced* / Q000503:physiopathology / Q000628:therapy; D010384:Pelvic Bones / Q000378:metabolism; D010865:Pilot Projects; D016896:Treatment Outcome; D000077211:Zoledronic Acid
chemical_list: D015415:Biomarkers; D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D007093:Imidazoles; D000077211:Zoledronic Acid
keywords: HIV; annual administration; biennial administration; bisphosphonate; bone mineral density; dual-energy X-ray absorptiometry scan; osteoporosis; zoledronate