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Alendronate with Calcium and Vitamin D Supplementation Is Superior to Calcium and Vitamin D Alone in the Management of Decreased Bone Mineral Density in HIV-infected patients: Results of ACTG 5163
Grace A McComsey*1, M Kendall2, P Tebas3, S Swindells4, E Hogg5, B Alston-Smith6, C Suckow7, G Gopalakrishnan8, C Benson9, D Wohl10, and AIDS Clinical Trials Group ACTG 5163
1Case Western Reserve Univ, Cleveland, OH, US; 2Statistical & Data Analysis Ctr, Harvard Sch of Publ Hlth, Boston, MA, US; 3Univ of Pennsylvania, Philadelphia, US; 4Univ of Nebraska Med Ctr, Omaha, US; 5Social & Sci Systems, Silver Spring, MD, US; 6NIAID, NIH, Bethesda, MD, US; 7Frontier Sci & Tech Res Fndn, Amherst, NY, US; 8Brown Med Sch, Providence, RI, US; 9Univ of California, San Diego, US; and 10Univ of North Carolina at Chapel Hill, US
Background: Decreased bone
mineral density is prevalent in HIV-infected patients. Bisphosphonates,
potent inhibitors of bone resorption, are currently
the mainstay of treatment for postmenopausal and male osteoporosis
in the HIV uninfected; however, their efficacy and safety in HIV-infected
patients remain unclear.
Methods: A5163 was
a prospective, randomized, placebo-controlled multicenter
trial to evaluate the effectiveness of calcium and vitamin D supplementation
with or without once-weekly alendronate (70 mg) in
improving bone mineral density in HIV-infected individuals with lumbar spine
t-scores ≤ –1.5. The study was powered to detect differences of 3.5%
between arms and to evaluate moderate effects of gender in the response to
therapy. All DEXA scans were analyzed centrally, blinded by arm.
Results: The 82 patients
enrolled were 71% males, 77% white, with a baseline median age of 48 years.
Median CD4 was 469 cells/mm3 and 91% had HIV RNA <400 copies/mL. Median baseline lumbar spine t-score was –2.1. Compared
with calcium/vitamin D, alendronate + calcium/vitamin
D resulted in improvements in lumbar spine (3.38% vs
1.10%, p = 0.03), total hip (3.95% vs 1.31%, p = 0.004),
and trochanter (4.52% vs
0.72%, p = 0.03), but not femoral
neck (2.21% vs 1.24%, p = 0.35). There was at least a trend toward increase in the bone
mineral density values in calcium/vitamin D at lumbar spine, total hip and
femoral neck, with p = 0.08, 0.03,
and 0.07 respectively, compared to baseline. Black race was associated with a smaller
change from baseline in bone mineral density of lumbar spine with alendronate. There were no apparent gender differences in
the responses to therapy. Alendronate was well
tolerated, without significant adverse events.
Conclusions: The results
demonstrate that once-weekly alendronate is
safe and efficacious in the treatment of decreased bone mineral density in
HIV-infected patients. Vitamin D and calcium alone is associated with modest
improvements in bone mineral density.
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