title: Zoledronic acid markedly improves bone mineral density for patients with monoclonal gammopathy of undetermined significance and bone loss.
abstract: OBJECTIVE
  Patients with monoclonal gammopathy of undetermined significance (MGUS) have increased rates of bone resorption, osteopenia, osteoporosis, and risk of fractures. This study was undertaken to determine the efficacy and safety of zoledronic acid for patients with MGUS and enhanced bone loss.
  
  
  METHODS
  In this phase II open-label study, 54 patients with MGUS and osteopenia or osteoporosis were administered zoledronic acid 4 mg i.v. at 0, 6, and 12 months. The primary efficacy end point was bone mineral density, assessed using a dual-energy X-ray absorptiometry scan in the lumbar (L)-spine done at screening and at 13 months (1 month after the final zoledronic acid infusion).
  
  
  RESULTS
  At study end for all patients (N = 54), L-spine T-scores improved by a median of +0.27 (range, -0.38 to +3.91), corresponding to a median increase in bone mineral density of +15.0% (range, -18.0% to +1,140.0%; P < 0.0001). Hip T-scores improved by a median of +0.10 (range, -2.40 to +2.03), corresponding to a median increase of +6.0% (range, -350.0% to +165.0%). During the study, no new fractures, osteonecrosis of the jaw, or significant renal adverse events were reported.
  
  
  CONCLUSIONS
  Zoledronic acid administered i.v. at a dosage of 4 mg every 6 months for three doses total was well-tolerated and substantially improved bone mineral density for patients with MGUS and bone loss. Zoledronic acid may be effective for the prevention of new fractures in this high-risk population.
authors.affiliation: Oncotherapeutics, Institute for Myeloma and Bone Cancer Research, James R. Berenson, M.D., Inc., 9201 West Sunset Boulevard, West Hollywood, CA 90069, USA. jberenson@imbcr.org
authors.forename: James R
authors.initials: JR
authors.lastname: Berenson
authors.forename: Ori
authors.initials: O
authors.lastname: Yellin
authors.forename: Ralph V
authors.initials: RV
authors.lastname: Boccia
authors.forename: Marshall
authors.initials: M
authors.lastname: Flam
authors.forename: Siu-Fun
authors.initials: SF
authors.lastname: Wong
authors.forename: Olcay
authors.initials: O
authors.lastname: Batuman
authors.forename: Mehdi M
authors.initials: MM
authors.lastname: Moezi
authors.forename: Donald
authors.initials: D
authors.lastname: Woytowitz
authors.forename: Herbert
authors.initials: H
authors.lastname: Duvivier
authors.forename: Youram
authors.initials: Y
authors.lastname: Nassir
authors.forename: Regina A
authors.initials: RA
authors.lastname: Swift
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015519:Bone Density; D050071:Bone Density Conservation Agents / Q000494:pharmacology*; D001847:Bone Diseases / Q000188:drug therapy*; D004164:Diphosphonates / Q000494:pharmacology*; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000494:pharmacology*; D008159:Lumbar Vertebrae / Q000000981:diagnostic imaging / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D008998:Monoclonal Gammopathy of Undetermined Significance / Q000188:drug therapy*; D010020:Osteonecrosis; D011859:Radiography; D013997:Time Factors; D014965:X-Rays; D000077211:Zoledronic Acid
chemical_list: D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D007093:Imidazoles; D000077211:Zoledronic Acid