title: Zoledronic acid for the treatment of osteoporosis in patients with beta-thalassemia: results from a single-center, randomized, placebo-controlled trial.
abstract: OBJECTIVE
  The aim of this study was to evaluate the effect of zoledronic acid (ZA) on thalassemia-induced osteoporosis.
  
  
  METHODS
  We studied 66 thalassemia patients with osteoporosis, who were randomized to receive 4 mg ZA iv, every 6 months (23 patients; group A) or every 3 months (21 patients; group B), or to receive placebo every 3 months (22 patients; group C), for a period of 1 year. Bone mineral density (BMD) of the lumbar spine, femoral neck and wrist was determined before and 12 months after treatment. Pain scores and markers of bone resorption [C-telopeptide of collagen type-I (CTX), 5b-isoform of TRAP], bone formation [bone-alkaline phosphatase (bALP), osteocalcin (OC), C-telopeptide of procollagen type-I (CICP)], and osteoclast stimulators [sRANKL, osteoprotegerin (OPG), osteopontin] were also measured at baseline and before each treatment administration.
  
  
  RESULTS
  The values of CTX, bALP, CICP, sRANKL, and OPG were higher in the all patients than in the controls. Patients in group A showed no differences in BMD of all sites at 12 months, while they had reductions in bone pain, bALP, OC and OPG. Conversely patients in group B had a significant increase in their lumbar spine BMD, which was accompanied by dramatic reductions in bone pain, CTX, bALP, CICP, and OC. Patients in group C showed no alteration in BMD of any studied site or in bone pain, while they had an aggravation in bone resorption.
  
  
  CONCLUSIONS
  ZA, at a dose of 4 mg, iv, every 3 months is an effective treatment for increasing BMD and reducing bone resorption in thalassemia-induced osteoporosis.
authors.affiliation: Thalassaemia Center, Laikon General Hospital, 16 Sevastoupoleos Street, GR 11526, Athens, Greece. ersi_voskaridou@yahoo.com
authors.forename: Ersi
authors.initials: E
authors.lastname: Voskaridou
authors.forename: Athanasios
authors.initials: A
authors.lastname: Anagnostopoulos
authors.forename: Kostas
authors.initials: K
authors.lastname: Konstantopoulos
authors.forename: Eleni
authors.initials: E
authors.lastname: Stoupa
authors.forename: Evgenia
authors.initials: E
authors.lastname: Spyropoulou
authors.forename: Christos
authors.initials: C
authors.lastname: Kiamouris
authors.forename: Evangelos
authors.initials: E
authors.lastname: Terpos
mesh_terms: D015519:Bone Density / Q000187:drug effects; D001862:Bone Resorption; D004164:Diphosphonates / Q000008:administration & dosage* / Q000494:pharmacology; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage* / Q000494:pharmacology; D010024:Osteoporosis / Q000188:drug therapy* / Q000209:etiology; D010919:Placebos; D016896:Treatment Outcome; D000077211:Zoledronic Acid; D017086:beta-Thalassemia / Q000150:complications* / Q000188:drug therapy
chemical_list: D004164:Diphosphonates; D007093:Imidazoles; D010919:Placebos; D000077211:Zoledronic Acid