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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
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Reported by Jules Levin
CROI, Feb 26, 2007, Los Angeles
Grace A McComsey from Western Reserve Univ, Cleveland, Ohio and the ACTG reported these study results.
McComsey concluded:
"Alendronate given with calcium/vitamin D led to significant increases in lumbar spine, total hip and trochanter BMD. Calcium/vitamin D alone led to modest increase in BMD. Alendronate was well tolerated, without significant adverse events. There was no evidence of treatment/gender interactions at any of the bone sites examined".
Changes reported were week 48 results. Changes from week 0 to week 24 strongly predicted changes fron week 0 to week 48.
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.
There were more signs/symptoms of grade >/=3 in placebo arm (15% vs 0% in the alendronate arm, p=0.01); no difference between treatment arms in grade >/=3 lab toxicities (15% on placebo vs 17% on alendronate, p>0/9); no discontinuation related to toxicity.
21% of patients changed ARV during study (5 TDF), results unchanged when these 5 subjects were excluded.
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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