Bisphosphonate therapy for HIV-Associated osteopenia

描述（由申请人提供）：hiv相关的骨质减少是最近公认的健康问题。感染艾滋病毒的男子和妇女都受到影响。在最近一项针对hiv感染者的研究中，服用蛋白酶抑制剂的受试者患骨质减少和骨质疏松症的风险是未服用蛋白酶抑制剂的受试者的两倍多。此外，与年龄和体重相似的健康对照组相比，感染艾滋病毒的妇女和患有艾滋病的妇女骨密度显著降低。此外，在这一人群中有与骨质减少相关的显著发病率的报道。据估计，在一些艾滋病毒感染群体中，这种疾病的患病率高达67.5%。

DESCRIPTION (provided by applicant): HIV-associated osteopenia is a recently recognized health problem. Both HIV-infected men and women are affected. In a recent study among a group of HIV-infected men, subjects taking protease inhibitors had more than double the risk of osteopenia and osteoporosis as compared with subjects not receiving protease inhibitors. In addition, HIV-infected women and women with AIDS wasting have significantly reduced bone density as compared to age and weight-similar healthy controls. Furthermore, significant morbidity associated with osteopenia has been reported in this population. The prevalence of this disease has been estimated as high as 67.5% in some HIV infected groups. Bisphosphonates have been widely used for treating osteoporosis and have been demonstrated to increase bone mineral density and reduce the rate of fracture. A recent study using intravenous zoledronate, a third-generation bisphosphonate, in postmenopausal women with osteopenia demonstrated beneficial improvements in bone density and significant reductions in bone resorption up to one year after single intravenous zoledronate dosing. Given the assurance of treatment delivery with single intravenous dosing and long-term health benefits, zoledronate appears to be an ideal treatment regimen for osteopenic HIV-infected subjects with complicated medical treatment regimens and medical compliance issues. We propose a double-blinded, placebo-controlled, randomized controlled trial to evaluate the effectiveness of intravenous zoledronate in HIV-infected subjects with osteopenia. We will determine whether zoledronate increases bone density and reduces ongoing bone loss in subjects with HIV-associated osteopenia. Long-term outcomes will include whether zoledronate reduces the risk of vertebral fracture and other osteopenia-associated morbidities in HIV-infected subjects. Given the polypharmacy often present in HIV-infected patients, we will also closely monitor the safety of zoledronate therapy and potential drug interactions in subjects on antiretroviral therapy. Finally, data generated by this pilot study will lay the foundation for future studies of bisphosphonate therapy in HIV-infected persons with bone disease.