Objective: To evaluate the change in bone mineral density (BMD) at specific sites in patients initiating antiretroviral therapy in a substudy of the ANRS 121 trial.
Methods: Antiretroviral-naive patients were randomized (2: 1: 1) into three treatment strategy arms: a nonnucleoside reverse transcriptase inhibitor (NNRTI) and a boosted protease inhibitor (PI/r), a PI/r and two nucleoside reverse transcriptase inhibitors (NRTIs) or an NNRTI and NRTIs. Hip and lumbar spine standardized BMD were evaluated at baseline and week 48 by dual X-ray absorptiometry by a central reading laboratory.
Results: Seventy-one patients were enrolled: 36 in the PI/r and NNRTI, 19 in the PI/r and NRTIs and 16 in the NNRTI and NRTIs arms. Baseline characteristics were [median (interquartile range)]: male (77%), age 40 years (33–49), 69% white, 58% smokers, BMI 23 kg/m2 (21–24), CD4 cell count 219 cells/μl (144–285). In the arms with NRTIs, 86% of patients received zidovudine/lamivudine. At baseline, 31% had osteopenia and 3% had osteoporosis. At week 48, there was a mean change in BMD of −4.1 ± 3.9% at lumbar spine and −2.8 ± 4.7% at hip (both P≤ 0.001). The decrease of BMD at lumbar spine was significantly worse in the PI/r and NNRTI arm (−4.4 ± 3.4%) and in the PI/r and NRTIs arm (−5.8 ± 4.5%) compared with the NNRTI and NRTIs arm (−1.5 ± 2.9%), P = 0.007 and P = 0.001, respectively.
Conclusion: BMD was impaired in 34% of patients, before starting any antiretrovirals. After 1 year, the decrease in lumbar spine BMD was more pronounced in patients receiving either PI/r-containing regimen compared with NNRTI and NRTIs. BMD at specific sites should be monitored during lifelong antiretroviral therapy.
aAP-HP, Groupe hospitalier Pitié Salpétrière, Service de Maladies Infectieuses et Tropicales, France
bINSERM, U943, France
cUPMC Univ Paris 06, UMR-S 943, France
dDepartment of Rheumatology, Paris-Descartes University, Cochin Hospital, France
eAP-HP, Hôpital Pitié Salpétrière, Service de Rhumatologie, UPMC Univ Paris 06, Paris, France.
* Present address: AP-HP, Groupe hospitalier Necker-Enfants Malades, Service de Maladies Infectieuses et Tropicales; Université Descartes-Paris5, Centre Médical de l'Institut Pasteur; Centre d'Infectiologie Necker-Pasteur, Département Infection et Epidémiologie, Institut Pasteur, Paris, France.
† Present address: AP-HP, Groupe hospitalier Bicêtre, Service de Médecine Interne et Maladies Infectieuses; Université Paris Sud11, Le Kremlin-Bicêtre, France.
Received 27 October, 2008
Revised 14 December, 2008
Accepted 18 December, 2008
Correspondence to Dominique Costagliola, INSERM U943, 56 Bd V Auriol, BP 335, 75625 Paris cedex 13, France. Tel: +33 1 42 16 42 82; fax: +33 1 42 16 42 61; e-mail: firstname.lastname@example.org