title: Alendronate reduces bone resorption in HIV-associated osteopenia/osteoporosis.
abstract: OBJECTIVE
  To evaluate the effects of alendronate, vitamin D, and calcium supplementation on bone metabolism and bone mineral density (BMD) in both HIV-infected men and women treated with highly active antiretroviral therapy (HAART).
  
  
  METHODS
  We performed a 52-week prospective, multicenter, randomized, open-label clinical trial. Eligible participants were on stable HAART and had BMD values at the femoral neck or lumbar spine that corresponded to a t score less than -1. Patients were randomized to receive alendronate 70 mg weekly or no alendronate; calcium 1000 mg daily and vitamin D 500 IU daily were provided to all study recipients. Primary endpoint of the study was the change in bone metabolism evaluated by N-telopeptide of type 1 collagen and bone-specific alkaline phosphatase; the secondary endpoint was BMD variation.
  
  
  RESULTS
  18 patients were randomized to the alendronate and 23 to the no-alendronate group (controls). The alendronate-treatment group compared to controls had a significant decrease in serum N-telopeptides, 1914 +/- 1433.4 vs. 3967 +/- 1650.5 pM/L (p = .005) after 1 year. Lumbar spine BMD increased by 4% in the alendronate group (p = .004) vs. 3.7% (p = .062) in controls, compared to baseline values. Femoral neck BMD decreased by 0.5% in the alendronate group (p = .05) and by 3.5% in the control group (p = .04). No between-groups differences for BMD were found (Delta lumbar-BMD 0.0351 +/- 0.0406 in cases and 0.0356 +/- 0.073 in controls [p = .977], Delta femoral-BMD -0.085 +/- 0.160 in cases and -0.100 +/- 0.165 in controls [p = .795]).
  
  
  CONCLUSIONS
  Alendronate plus vitamin D and calcium was effective in reducing bone resorption. Alendronate improved lumbar BMD and minimized femoral BMD decrease after 52 weeks compared to treatment with vitamin D and calcium alone in patients on HAART with osteopenia/osteoporosis.
authors.affiliation: Dipartimento di Medicina e Specialità Mediche, School of Medicine, University of Modena and Reggio Emilia, via del Pozzo 71, 41100 Modena, Italy. g.guaraldi@unimo.it
authors.forename: G
authors.initials: G
authors.lastname: Guaraldi
authors.forename: G
authors.initials: G
authors.lastname: Orlando
authors.forename: G
authors.initials: G
authors.lastname: Madeddu
authors.forename: F
authors.initials: F
authors.lastname: Vescini
authors.forename: P
authors.initials: P
authors.lastname: Ventura
authors.forename: S
authors.initials: S
authors.lastname: Campostrini
authors.forename: M S
authors.initials: MS
authors.lastname: Mura
authors.forename: N
authors.initials: N
authors.lastname: Parise
authors.forename: R
authors.initials: R
authors.lastname: Caudarella
authors.forename: R
authors.initials: R
authors.lastname: Esposito
mesh_terms: D000284:Administration, Oral; D000328:Adult; D019386:Alendronate / Q000008:administration & dosage / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D015519:Bone Density; D001851:Bone Diseases, Metabolic / Q000150:complications / Q000188:drug therapy; D004334:Drug Administration Schedule; D005260:Female; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000150:complications / Q000188:drug therapy*; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D019386:Alendronate