title: Improvement in bone mineral density after switching from tenofovir to abacavir in HIV-1-infected patients with low bone mineral density: two-centre randomized pilot study (OsteoTDF study).
abstract: BACKGROUND
  Tenofovir has been associated with a decrease in bone mineral density (BMD). However, data on changes in BMD after discontinuing tenofovir are lacking.
  
  
  METHODS
  We performed a two-centre randomized pilot study in virologically suppressed HIV-infected patients receiving tenofovir with osteopenia/osteoporosis (OsteoTDF study, ClinicalTrials.gov number NCT 01153217). Fifty-four patients were randomly assigned to switch from tenofovir to abacavir (n = 26) or to continue with tenofovir (n = 28). Changes in lumbar and total hip BMD were evaluated at Week 48 from baseline.
  
  
  RESULTS
  Five patients discontinued the study (three from the tenofovir group and two from the abacavir group). No significant differences were detected between the groups at Week 48 (P = 0.229 for total hip and P = 0.312 for lumbar spine). However, hip BMD improved by 2.1% (95% CI -0.6 to 4.7) (P = 0.043) in the abacavir group and 0.7% (95% CI -0.9 to 2.4) (P = 0.372) in the tenofovir group. Lumbar spine BMD varied by -0.7% (95% CI -3.8 to 3.3) (P ≤ 0.001) in the abacavir group and -1.2% (95% CI -3.8 to 0.4) (P < 0.001) in the tenofovir group.
  
  
  CONCLUSIONS
  Switching from tenofovir to abacavir led to a slight improvement in femoral BMD although no differences were detected between groups. Larger studies are necessary before firm recommendations can be made on the discontinuation of tenofovir in patients with a low BMD.
authors.affiliation: Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Eugènia
authors.initials: E
authors.lastname: Negredo
authors.affiliation: Santa Creu i Sant Pau Hospital, Barcelona, Spain Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Pere
authors.initials: P
authors.lastname: Domingo
authors.affiliation: Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain Universitat Autònoma de Barcelona, Barcelona, Spain Statistics and Operations Research Department, Universitat Politècnica de Catalunya, Barcelona, Spain.
authors.forename: Núria
authors.initials: N
authors.lastname: Pérez-Álvarez
authors.affiliation: Santa Creu i Sant Pau Hospital, Barcelona, Spain Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Mar
authors.initials: M
authors.lastname: Gutiérrez
authors.affiliation: Santa Creu i Sant Pau Hospital, Barcelona, Spain Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Gracia
authors.initials: G
authors.lastname: Mateo
authors.affiliation: Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Jordi
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, Barcelona, Spain.
authors.forename: Roser
authors.initials: R
authors.lastname: Escrig
authors.affiliation: Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Patricia
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, Barcelona, Spain abonjoch@flsida.org.
authors.forename: Anna
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, Barcelona, Spain Irsicaixa Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain.
authors.forename: Bonaventura
authors.initials: B
authors.lastname: Clotet
mesh_terms: D000225:Adenine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015519:Bone Density; D015224:Dideoxynucleosides / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D063065:Organophosphonates / Q000009:adverse effects / Q000627:therapeutic use*; D010024:Osteoporosis / Q000139:chemically induced* / Q000473:pathology; D010865:Pilot Projects; D000068698:Tenofovir; D016896:Treatment Outcome; D000099227:Abacavir
chemical_list: D000225:Adenine; D019380:Anti-HIV Agents; D015224:Dideoxynucleosides; D063065:Organophosphonates; D000068698:Tenofovir; D000099227:Abacavir
keywords: DXA scan; HIV-infected patients; osteoporosis; virologically suppressed