Alendronate/Vitamin D for attenuating bone mineral density loss during antiretroviral initiation: a pilot randomized controlled trial

References

• Cummings SR, Black DM, Nevitt MC, et al. Bone density at various sites for prediction of hip fractures. The Study of Osteoporotic Fractures Research Group. Lancet 1993;341(8837):72–75.
   PubMed Web of Science ®Google Scholar
• Arnsten JH, Freeman R, Howard AA, Floris-Moore M, Lo Y, Klein RS. Decreased bone mineral density and increased fracture risk in aging men with or at risk for HIV infection. AIDS 2007;21(5):617–623.
   PubMed Web of Science ®Google Scholar
• Arnsten JH, Freeman R, Howard AA, Floris-Moore M, Santoro N, Schoenbaum EE. HIV infection and bone mineral density in middle-aged women. Clin Infect Dis. 2006;42(7):1014–1020.
   PubMed Web of Science ®Google Scholar
• Gallant JE, Staszewski S, Pozniak AL, et al. Efficacy and safety of tenofovir DF vs stavudine in combination therapy in antiretroviral-naive patients: a 3-year randomized trial. JAMA 2004;292(2):191–201.
   PubMed Web of Science ®Google Scholar
• Nolan D, Upton R, McKinnon E, et al. Stable or increasing bone mineral density in HIV-infected patients treated with nelfinavir or indinavir. AIDS 2001;15(10):1275–1280.
   Web of Science ®Google Scholar
• Amiel C, Ostertag A, Slama L, et al. BMD is reduced in HIV-infected men irrespective of treatment. J Bone Miner Res. 2003;19(3):402–409.
   Web of Science ®Google Scholar
• Fausto A, Bongiovanni M, Cicconi P, et al. Potential predictive factors of osteoporosis in HIV-positive subjects. Bone 2006;38(6):893–897.
   PubMed Web of Science ®Google Scholar
• Grund B, Peng G, Gibert CL, et al. Continuous antiretroviral therapy decreases bone mineral density. AIDS 2009;23(12):1519–1529.
   PubMed Web of Science ®Google Scholar
• Brown TT, Qaqish RB. Antiretroviral therapy and the prevalence of osteopenia and osteoporosis: a meta-analytic review. AIDS 2006;20(17):2165–2174.
   PubMed Web of Science ®Google Scholar
• Triant VA, Brown TT, Lee H, Grinspoon SK. Fracture prevalence among human immunodeficiency virus (HIV)-infected versus non-HIV-infected patients in a large U.S. healthcare system. J Clin Endocrinol Metab. 2008;93(9):3499–3504.
   PubMed Web of Science ®Google Scholar
• Bedimo R, Maalouf NM, Zhang S, Drechsler H, Tebas P. Osteoporotic fracture risk associated with cumulative exposure to tenofovir and other antiretroviral agents. AIDS 2012;26(7):825–831.
   PubMed Web of Science ®Google Scholar
• Young B, Dao CN, Buchacz K, Baker R, Brooks JT, the HIV Outpatient Study (HOPS) Investigators. Increased rates of bone fracture among HIV-infected persons in the HIV Outpatient Study (HOPS) compared with the US general population, 2000-2006. Clin Infect Dis. 2011;52(8):1061–1068.
   PubMed Web of Science ®Google Scholar
• Kado DM, Browner WS, Palermo L, Nevitt MC, Genant HK, Cummings SR. Vertebral fractures and mortality in older women: a prospective study. Study of Osteoporotic Fractures Research Group. Arch Intern Med. 1999;159(11):1215–1220.
   PubMed Web of Science ®Google Scholar
• Ross PD, He YF, Davis JW, Epstein RS, Wasnich RD. Normal ranges for bone loss rates. Bone Miner. 1994;26(2):169–180.
   Google Scholar
• Fakruddin JM, Laurence J. HIV-1 Vpr enhances production of receptor of activated NF-kappaB ligand (RANKL) via potentiation of glucocorticoid receptor activity. Arch Virol. 2005;150(1):67–78.
   PubMed Web of Science ®Google Scholar
• Fakruddin JM, Laurence J. HIV envelope gp120-mediated regulation of osteoclastogenesis via receptor activator of nuclear factor kappa B ligand (RANKL) secretion and its modulation by certain HIV protease inhibitors through interferon-gamma/RANKL cross-talk. J Biol Chem. 2003;278(48):48251–48258.
   PubMed Web of Science ®Google Scholar
• van Vonderen MG, Lips P, van Agtmael MA, et al. First line zidovudine/lamivudine/lopinavir/ritonavir leads to greater bone loss compared to nevirapine/lopinavir/ritonavir. AIDS 2009;23(11):1367–1376.
   PubMed Web of Science ®Google Scholar
• Brown TT, McComsey GA, King MS, Qaqish RB, Bernstein BM, da Silva BA. Loss of bone mineral density after antiretroviral therapy initiation, independent of antiretroviral regimen. J Acquir Immune Defic Syndr. 2009;51(5):554–561.
   PubMed Web of Science ®Google Scholar
• Duvivier C, Kolta S, Assoumou L, et al. Greater decrease in bone mineral density with protease inhibitor regimens compared with nonnucleoside reverse transcriptase inhibitor regimens in HIV-1 infected naive patients. AIDS 2009;23:817–824.
   PubMed Web of Science ®Google Scholar
• Papaioannou A, Morin S, Cheung AM, et al. 2010 clinical practice guidelines for the diagnosis and management of osteoporosis in Canada: summary. CMAJ 2010;182(17):1864–1873.
   PubMed Web of Science ®Google Scholar
• Aberg JA, Kaplan JE, Libman H, et al. Primary care guidelines for the management of persons infected with human immunodeficiency virus: 2009 update by the HIV medicine Association of the Infectious Diseases Society of America. Clin Infect Dis. 2009;49(5):651–681.
   PubMed Web of Science ®Google Scholar
• McComsey GA, Tebas P, Shane E, et al. Bone disease in HIV infection: a practical review and recommendations for HIV care providers. Clin Infect Dis. 2010;51(8):937–946.
   PubMed Web of Science ®Google Scholar
• McComsey GA, Kendall MA, Tebas P, et al. Alendronate with calcium and vitamin D supplementation is safe and effective for the treatment of decreased bone mineral density in HIV. AIDS 2007;21(18):2473–2482.
   PubMed Web of Science ®Google Scholar
• Mondy K, Powderly WG, Claxton SA, et al. Alendronate, vitamin D, and calcium for the treatment of osteopenia/osteoporosis associated with HIV infection. J Acquir Immune Defic Syndr. 2005;38(4):426–431.
   PubMed Web of Science ®Google Scholar
• Guaraldi G, Orlando G, Madeddu G, et al. Alendronate reduces bone resorption in HIV-associated osteopenia/osteoporosis. HIV Clin Trials. 2004;5(5):269–277.
   PubMed Web of Science ®Google Scholar
• MacLean C, Newberry S, Maglione M, et al. Systematic review: comparative effectiveness of treatments to prevent fractures in men and women with low bone density or osteoporosis. Ann Intern Med. 2008;148(3):197–213.
   PubMed Web of Science ®Google Scholar
• McClung M, Clemmesen B, Daifotis A, et al. Alendronate prevents postmenopausal bone loss in women without osteoporosis. A double-blind, randomized, controlled trial. Alendronate Osteoporosis Prevention Study Group. Ann Intern Med. 1998;128(4):253–261.
   Web of Science ®Google Scholar
• Hosking D, Chilvers CE, Christiansen C, et al. Prevention of bone loss with alendronate in postmenopausal women under 60 years of age. Early Postmenopausal Intervention Cohort Study Group. N Engl J Med. 1998;338(8):485–492.
   PubMed Web of Science ®Google Scholar
• Ravn P, Bidstrup M, Wasnich RD, et al. Alendronate and estrogen-progestin in the long-term prevention of bone loss: four-year results from the early postmenopausal intervention cohort study. A randomized, controlled trial. Ann Intern Med. 1999;131(12):935–942.
   PubMed Web of Science ®Google Scholar
• McClung MR, , Wasnich RD, Hosking DJ, et al. Prevention of postmenopausal bone loss: six-year results from the Early Postmenopausal Intervention Cohort Study. J Clin Endocrinol Metab.2004;89(10):4879–4885.
   Web of Science ®Google Scholar
• Saag KG, Emkey R, Schnitzer TJ, et al. Alendronate for the prevention and treatment of glucocorticoid-induced osteoporosis. Glucocorticoid-Induced Osteoporosis Intervention Study Group. N Engl J Med. 1998;339(5):292–299.
   PubMed Web of Science ®Google Scholar
• Adachi JD, Saag KG, Delmas PD, et al. Two-year effects of alendronate on bone mineral density and vertebral fracture in patients receiving glucocorticoids: a randomized, double-blind, placebo-controlled extension trial. Arthritis Rheum. 2001;44(1):202–211.
   PubMedGoogle Scholar
• Stoch SA, Saag KG, Greenwald M, et al. Once-weekly oral alendronate 70 mg in patients with glucocorticoid-induced bone loss: a 12-month randomized, placebo-controlled clinical trial. J Rheumatol. 2009;36(8):1705–1714.
   PubMed Web of Science ®Google Scholar
• Greenspan SL, Nelson JB, Trump DL, Resnick NM. Effect of once-weekly oral alendronate on bone loss in men receiving androgen deprivation therapy for prostate cancer: a randomized trial. Ann Intern Med. 2007;146(6):416–424.
   Web of Science ®Google Scholar
• Klotz LH, McNeill IY, Kebabdjian M, Zhang L, Chin J. A phase 3, double-blind, randomised, parallel-group, placebo-controlled study of oral weekly alendronate for the prevention of androgen deprivation bone loss in nonmetastatic prostate cancer: the cancer and osteoporosis research with alendronate and leuprolide (CORAL) study. Eur Urol 2012;
   Web of Science ®Google Scholar
• Overton ET, Chan ES, Brown TT, et al. Vitamin D and calcium attenuate bone loss with antiretroviral therapy initiation: a randomized trial. Ann Intern Med. 2015;162(12):815–824.
   PubMed Web of Science ®Google Scholar
• Ofotokun I, Titanji K, Lahiri CD, et al. A single-dose zoledronic acid infusion prevents antiretroviral therapy-induced bone loss in treatment-naive HIV-infected patients: a phase IIb trial. Clin Infect Dis. 2016;63(5):663–671. Epub 2016 May 18.
   PubMed Web of Science ®Google Scholar
• Thabane L, Ma J, Chu R, et al. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010;10(1):1. 10.1186/471-2288-10-1.
   PubMed Web of Science ®Google Scholar
• Baranek B, Wang S, Cheung AM, Mishra S, Tan D. What does HIV pre-exposure prophylaxis (PrEP) do to bone health? A systematic review and meta-analysis. Paper presented at: 27th Canadian Conference on HIV/AIDS Research Poster CSP701; 2018; Vancouver, Canada.
   Google Scholar
• Sax PE, Wohl D, Yin MT, et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials. Lancet. 2015;385(9987):2606–2615.
   PubMed Web of Science ®Google Scholar
• Sax PE, Wohl D, Yin MT, et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials. Lancet 2015;385(9987):2606–2615. Epub 2015 Apr 15.
   PubMed Web of Science ®Google Scholar
• Mills A, Arribas JR, Andrade-Villanueva J, et al. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral regimens for virologically suppressed adults with HIV-1 infection: a randomised, active-controlled, multicentre, open-label, phase 3, non-inferiority study. Lancet Infect Dis. 2016;16(1):43–52. Epub 2015 Nov 2.
   PubMed Web of Science ®Google Scholar
• Teeraananchai S, Kerr SJ, Amin J, Ruxrungtham K, Law MG. Life expectancy of HIV-positive people after starting combination antiretroviral therapy: a meta-analysis. HIV Med. 2017;18(4):256–266. Epub 2016 Aug 31.
   PubMed Web of Science ®Google Scholar
• Marshall D, Johnell O, Wedel H. Meta-analysis of how well measures of bone mineral density predict occurrence of osteoporotic fractures. BMJ 1996;312(7041):1254–1259.
   PubMed Web of Science ®Google Scholar