Track topics on Twitter Track topics that are important to you
Alendronate is a drug that is used to treat osteoporosis. The purpose of this study is to examine whether alendronate in combination with calcium and vitamin D is safe and effective for treating bone loss in people with HIV.
Decreased bone mineral density (BMD) has been identified in up to 50% of HIV infected men, with severe osteoporosis in up to 21% of these men. The mechanisms underlying these bone abnormalities remain unclear. Bisphosphonates are potent bone resorption inhibitors and have been shown to be effective in treating osteoporosis. While several bisphosphonates are approved for the treatment of osteoporosis in women, alendronate is the only bisphosphonate approved for treatment in men. This study hypothesizes that alendronate will be able to reverse decreased BMD secondary to inhibition of bone resorption in HIV infected patients treated with potent antiretroviral therapy, and that these patients will be able to tolerate alendronate without any significant toxicities. The study will also examine the efficacy of once-weekly alendronate with daily calcium and vitamin D in both men and women with HIV.
Patients will participate in this study for 48 weeks. Patients will be randomly assigned to receive either alendronate or placebo. All patients will receive calcium and vitamin D. Dual energy x-ray absorptiometry (DEXA) scans will be used to evaluate bone density at each visit. After study entry, patients will have visits at Weeks 2, 12, 24, 36, and 48. During these visits, blood will be drawn and a pregnancy test may be performed. Patients must fast for at least 8 hours prior to the entry visit and for the visits at Weeks 2, 12, 24, and 48.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Alendronate, Calcium carbonate, Vitamin D
University of Alabama-Birmingham
National Institute of Allergy and Infectious Diseases (NIAID)
Published on BioPortfolio: 2014-08-27T03:55:13-0400
HIV-infected children, youth, and adults have lower bone mineral density (BMD) than would be expected for HIV-uninfected people of similar age, weight and race. As the majority of perinata...
The purpose of this study is to see how well alendronate and calcium as compared to calcium alone increase bone density in postmenopausal women with osteoporosis
In recent years, vitamin D has been shown not only to be important for bone and calcium metabolism but also for homeostasis of critical tissues involved in vascular disease in patients wit...
The purpose of this study is to identify the best way to prevent bone loss in the first years after menopause. The HOPE study will compare bone loss at 12 months in women: 1) who take cal...
To examine the effects of two types of active vitamin D (calcitriol and doxercalciferol) and two phosphate binders (sevelamer and calcium carbonate) on the bone disease and blood tests of ...
Following Roux-en-Y gastric bypass (RYGB), elevated parathyroid hormone (PTH) levels potentially harmful to bone health are commonly observed. Owing to assumed superior absorption, calcium citrate is ...
Calcium carbonate was previously shown to interfere with L-thyroxine absorption. To estimate the magnitude of tablet L-thyroxine malabsorption caused by calcium carbonate, with resulting increase in s...
Animal studies using mice model such as vitamin D deficiency and global and conditional VDR knock out(KO)mice have disclosed that the physiological role of vitamin D strongly depends on the calcium ba...
The antirickets factor vitamin D exhibits its action through activation of vitamin D receptor(VDR). The active form of vitamin D, 1α,25-dihydroxyvitamin D3[1,25(OH)2D3], is a potent VDR ligand, and c...
This retrospective study assessed the effect of alendronate for treating patients with ankylosing spondylitis (AS).Eighty-six patients with AS were included in this retrospective study, and were divid...
Carbonic acid calcium salt (CaCO3). An odorless, tasteless powder or crystal that occurs in nature. It is used therapeutically as a phosphate buffer in hemodialysis patients and as a calcium supplement.
A field of chemistry which pertains to chemical compounds or ions that do not contain the element carbon (with the exception of carbon dioxide and compounds containing a carbonate radical, e.g., calcium carbonate).
A protein that plays a fundamental role in the Vitamin D mediated transport of calcium in reptiles, amphibians, birds and mammals. It is found in the intestine, kidneys, egg shell gland, brain, and possibly other organs. Its molecular weight is species dependent.
A vitamin that includes both CHOLECALCIFEROLS and ERGOCALCIFEROLS, which have the common effect of preventing or curing RICKETS in animals. It can also be viewed as a hormone since it can be formed in SKIN by action of ULTRAVIOLET RAYS upon the precursors, 7-dehydrocholesterol and ERGOSTEROL, and acts on VITAMIN D RECEPTORS to regulate CALCIUM in opposition to PARATHYROID HORMONE.
A lipid cofactor that is required for normal blood clotting. Several forms of vitamin K have been identified: VITAMIN K 1 (phytomenadione) derived from plants, VITAMIN K 2 (menaquinone) from bacteria, and synthetic naphthoquinone provitamins, VITAMIN K 3 (menadione). Vitamin K 3 provitamins, after being alkylated in vivo, exhibit the antifibrinolytic activity of vitamin K. Green leafy vegetables, liver, cheese, butter, and egg yolk are good sources of vitamin K.
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...
Alternative Medicine Cleft Palate Complementary & Alternative Medicine Congenital Diseases Dentistry Ear Nose & Throat Food Safety Geriatrics Healthcare Hearing Medical Devices MRSA Muscular Dyst...
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...