AEGiS-10CROI: Alendronate, Vitamin D, and Calcium for theTreatment of Osteopenia/Osteoporosis Associated with HIV Infection.

10th Conference on Retroviruses and Opportunistic Infections


Boston, MA USA - February 10 -14, 2003

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Alendronate, Vitamin D, and Calcium for theTreatment of Osteopenia/Osteoporosis Associated with HIV Infection.

Conf Retroviruses Opportunistic Infect 2003 Feb 10-14;10th: abstract no. 134
Mondy K, Powderly WG, Claxton SA, Yarasheski KE, Stoneman JS, Hoffmann ME, Tebas P; Washington Univ, St Louis, MO

BACKGROUND: Osteopenia and osteoporosis are frequent complications of HIV infection and/or its treatment. Alendronate is the only bisphosphonate approved for the treatment of osteoporosis in men and women. We conducted a 48 wk prospective, randomized, open label study to evaluate the effects of alendronate, vit D and calcium supplementation on bone mineral density (BMD) in patients (pts) with HIV infection.

METHODS: Thirty-one (31) HIV infected subjects on ART for a minimum of 6 months (mos) with lumbar spine BMD t scores less than -1.0, were randomized to receive 70 mg of alendronate (n = 15) or not (n = 16) weekly for 48 wks. All subjects received in addition calcium (1000 mg daily as calcium carbonate) and vit D (400 IU daily). The study was powered to detect 3% changes in BMD in the lumbar spine within arms.

RESULTS: Pts were 87% male, 80% Caucasian, 29% smokers, and 16% moderate drinkers. Sixty-one percent (61%) were on PI based regimens. The mean age was 44 yrs, and mean BMI was 25 kg/m2. Average length of HIV infection was 8 yrs, 84% had viral load below 400 copies/ml, current CD4+ T-cell count was 561 cells/µl (median nadir CD4 count 167 cells/µl). At baseline, median lumbar spine BMD t-score was -1.52, and median hip t-score was -1.02. Treatment effects are shown in the table: [table: see text] One subject discontinued treatment in each arm. There were no serious adverse events.

CONCLUSIONS: Alendronate, vit D, and calcium are safe and effective in the treatment of osteopenia/osteoporosis associated with HIV infection. Alendronate in combination with vit D and calcium increased lumbar spine BMD by 5.2% at 48 wks vs 1.3% of vit D and calcium alone. These results are consistent with the results observed in HIV- individuals. These data provide the basis for sample size calculations and support the evaluation of alendronate in larger randomized trials.

Keywords: AEGIS, Alendronate, Osteoporosis, Vitamin D, Bone Diseases, Metabolic, Bone Density, Calcium, Diphosphonates, HIV Infections, Calcium Carbonate, Calcium, Dietary, Selective Estrogen Receptor Modulators, Human, Female, MaleKWDaegis,alendronate,osteoporosis,vitamind,bonediseases,metabolic,bonedensity,calcium,diphosphonates,hivinfections,calciumcarbonate,calcium,dietary,selectiveestrogenreceptormodulators,human,female,male

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Copyright © 2003 - Foundation for Retrovirology and Human Health. Reproduction of this abstract (other than one copy for personal reference) must be cleared through the Foundation for Retrovirology and Human Health. Licensed (AIDSLINE) from National Library of Medicine.