title: Alendronate with calcium and vitamin D supplementation is safe and effective for the treatment of decreased bone mineral density in HIV.
abstract: BACKGROUND
  Decreased bone mineral density (BMD) is prevalent in HIV-infected patients. Bisphosphonates are currently the mainstay of treatment for postmenopausal and male osteoporosis in HIV-uninfected individuals; however, their efficacy and safety in HIV-infected patients remains unclear.
  
  
  METHODS
  In this prospective, randomized, placebo-controlled multicenter trial, we studied the effectiveness of calcium and vitamin D supplementation with or without alendronate in improving BMD in HIV-infected subjects receiving stable antiretroviral therapy. Subjects with secondary causes of osteoporosis were excluded. The study was powered to detect differences of 3.5% between arms and to detect a moderate sex effect in percentage change in lumbar spine BMD. All dual-energy X-ray absorptiometry scans were analysed centrally, blinded by arm.
  
  
  RESULTS
  The 82 subjects enrolled were 71% men, 77% white, with a baseline median age of 48 years, CD4 cell count of 469 cells/mul, and lumbar spine t-score of less than 2.1; 91% had HIV-RNA levels less than 400 copies/ml, and 99% were taking antiretroviral drugs. Compared with calcium/vitamin D alone, alendronate plus calcium/vitamin D resulted in significant improvements in BMD at the lumbar spine, total hip, and trochanter, but not at the femoral neck, compared with baseline. There were trends towards significant increases in BMD values in the calcium/vitamin D group at the lumbar spine, total hip, and femoral neck. There were no apparent sex differences in the responses to therapy. Alendronate was well tolerated, without significant adverse events.
  
  
  CONCLUSIONS
  Once-weekly alendronate is safe and effective in the treatment of decreased BMD in HIV-infected patients.
authors.affiliation: Rainbow Babies and Children's Hospital and Case Western Reserve University, Cleveland, Ohio, USA. gam9@case.edu
authors.forename: Grace A
authors.initials: GA
authors.lastname: McComsey
authors.forename: Michelle A
authors.initials: MA
authors.lastname: Kendall
authors.forename: Pablo
authors.initials: P
authors.lastname: Tebas
authors.forename: Susan
authors.initials: S
authors.lastname: Swindells
authors.forename: Evelyn
authors.initials: E
authors.lastname: Hogg
authors.forename: Beverly
authors.initials: B
authors.lastname: Alston-Smith
authors.forename: Carol
authors.initials: C
authors.lastname: Suckow
authors.forename: Geetha
authors.initials: G
authors.lastname: Gopalakrishnan
authors.forename: Constance
authors.initials: C
authors.lastname: Benson
authors.forename: David A
authors.initials: DA
authors.lastname: Wohl
mesh_terms: D015502:Absorptiometry, Photon; D019386:Alendronate / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002118:Calcium / Q000627:therapeutic use; D024042:Collagen Type I / Q000097:blood; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000150:complications*; D006801:Humans; D008297:Male; D010024:Osteoporosis / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D010455:Peptides / Q000097:blood; D011446:Prospective Studies; D012307:Risk Factors; D012737:Sex Factors; D016896:Treatment Outcome; D014807:Vitamin D / Q000627:therapeutic use
chemical_list: D015415:Biomarkers; D050071:Bone Density Conservation Agents; D024042:Collagen Type I; D010455:Peptides; C052929:collagen type I trimeric cross-linked peptide; D014807:Vitamin D; D002118:Calcium; D019386:Alendronate