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LING ZHENG, SHUCHENG ZHANG, CHARLES WOOD, SANJAY KAPIL, GRAHAM E. WILCOX, THOMAS A. LOUGHIN, AND H. C. MINOCHA Departments of Diagnostic Medicine Pathobiology and Statistics, Kansas State University, Manhattan, Kansas 66506; Intervet Incorporation, Millsboro, Delaware 19966; School of Biological Sciences, University of Nebraska, Lincoln, Nebraska 68588; and School of Veterinary Studies, Murdoch University, Murdoch 6150, Australia.
From the Department of Pediatrics M.E.G., W.V.T. ; , School of Medicine, Yale University, New Haven, Connecticut; and the West Virginia School of Medicine A.F Wheeling, West Virginia ; , Address correspondence to Margaret E. Griffin, MD, Pediatric Endocrinology, Yale University, 333 Cedar St., New Haven, CT 06520; e-mail: william.tamborlane yale.
Mixture of grains will "unmix" segregate ; itself based on particle size or mass as long as a gradient of velocity fluctuation is present in the flow. In the experiment, which is scheduled to run in 2009, the grains are contained in the gap between parallel cylindrical walls. The required distribution of granular fluctuation energy will be controlled by fitting the rotating cylindrical walls with "bumps" that have specific shapes and collision properties. Digital video will record the particles' trajectories between the rotating walls, and then, from the trajectories, researchers will extract mean velocities and fluctuation energy across the cell for each grain species. The experiment will quantify the geometric segregation of spheres with different sizes but equal masses and with different masses but equal sizes. Measurements will be compared with theory and with molecular dynamics simulations. In FY 2003, the team adjusted its imaging analysis method to detect metal spheres using a ring light an array of lights in a doughnut shape ; to distinguish between shiny and dull spherical particles and then compared their measurements of mean and fluctuating velocities with predictions of their numerical simulations and theory. The team also further developed its interactive evaluation tool to speed up data evaluation. SiGMA, conducted by PI Michel Louge and his team at Cornell University, studies the effect of surrounding gas on the dynamics of particles. Two aspects of the gasparticle interaction will be tested: dissipation of granular energy by the action of gas viscosity also called viscous dissipation ; and how the gas drag on the solids affects their distribution of fluctuation energy viscous drag ; . Scheduled to run in 2008, the experiments will measure two parameters that appear in new theories predicting viscous dissipation and viscous drag. The dependence of these parameters on solids concentration will be tested against the theoretical predictions. The flow cell is similar to that used in gSEG. However, the flow regime requires that the grain speeds be slower to bring out the effects of viscous forces exerted by the gas. In FY 2003, the SiGMA team -- like the other Cornell team -- adjusted its imaging analysis method to detect metal spheres using a ring light technique and then compared their measurements of mean and fluctuating velocities with predictions of their numerical simulations and theory. The team also further developed its interactive evaluation tool to speed up data evaluation. GGM, conducted by PI Robert Behringer of Duke University, Durham, North Carolina, will explore the fluctuation of forces in low- and high-density granular samples. The effects of the fluctuation range from clustering at low density to jamming particle chains at high density. In the flight hardware, the sample volume is the space between.
REVIEW BISPHOSPHONATES AND OSTEONECROSIS OF THE JAW This editor did not know about osteonecrosis of the jaw associated with bisphosphonate use until one of my students presented a case study of this side effect. Since 2004, there have been at least 30 case series published that total 368 patients who have suffered with this unusual adverse event. An excellent systematic review of osteonecrosis of the jaw was recently published in the Annals of Internal Medicine.7 The bisphosphonates are inhibitors of osteoclastic activity. Because they are incorporated into skeletal tissue without being degraded, they are "remarkably persistent drugs." The half-life of alendronate Fosamaax ; is estimated to be about 12 years. Other members of the nitrogen-containing bisphosphonate class include risedronate Actonel ; , pamidronate Aredia and others ; , zoledronic acid Zometa ; , and ibandronate Boniva ; . Nonaminobisphosphonates include tiludronate Skelid ; and etidronate Didronel ; . This review looks at the patients who are most at risk and explains why the jaw is a susceptible area for osteonecrosis development. It is interesting to note that up to a third of the lesions are found to be painless. Patients with metastatic breast cancer or multiple myeloma are the most likely candidates to develop this problem. REVIEW ANTIDEPRESSANTS AND PREGNANCY A recent editorial published in JAMA reviews the growing concern of women taking antidepressant medications during pregnancy.8 The author looks at the risks of mothers stopping the medication, the risks of continuing anti.
In patients with postmenopausal osteoporosis treated with FOSAMAX 10 mg day for one or two years, the effects of treatment withdrawal were assessed. Following discontinuation, there were no.
Dosing 2 hours before eating. In studies of treatment and prevention of osteoporosis, alendronate was effective when administered at least 30 minutes before breakfast. Bioavailability was negligible whether alendronate was administered with or up to two hours after a standardized breakfast. Concomitant administration of alendronate with coffee or orange juice reduced bioavailability by approximately 60%. Cholecalciferol Following administration of FOSAMAX PLUS D after an overnight fast and two hours before a standard meal, the baseline adjusted mean area under the serum-concentration-time curve AUC0-120 hrs ; for vitamin D3 was 120.7 ng-hr ml. The mean maximal serum concentration Cmax ; of vitamin D3 was 4.0 ng ml, and the mean time to maximal serum concentration Tmax ; was 10.6 hrs. The bioavailability of the 2800 IU vitamin D3 in FOSAMAX PLUS D is similar to 2800 IU vitamin D3 administered alone. Distribution Alendronate Sodium Preclinical studies in male rats ; show that alendronate transiently distributes to soft tissues following 1 mg kg IV administration but is then rapidly redistributed to bone or excreted in the urine. The mean steady-state volume of distribution, exclusive of bone, is at least 28 L in humans. Concentrations of drug in plasma following therapeutic oral doses are too low less than 5 ng ml ; for analytical detection. Protein binding in human plasma is approximately 78%. Cholecalciferol Following absorption, vitamin D3 enters the blood as part of chylomicrons. Vitamin D3 is rapidly distributed mostly to the liver where it undergoes metabolism to 25-hydroxyvitamin D3, the major storage form. Lesser amounts are distributed to adipose tissue and stored as vitamin D3 at these sites for later release into the circulation. Circulating vitamin D3 is bound to vitamin D-binding protein. Metabolism Alendronate Sodium There is no evidence that alendronate is metabolized in animals or humans. Cholecalciferol Vitamin D3 is rapidly metabolized by hydroxylation in the liver to 25-hydroxyvitamin D3, and subsequently metabolized in the kidney to 1, 25-dihydroxyvitamin D3, which represents the biologically active form. Further hydroxylation occurs prior to elimination. A small percentage of vitamin D3 undergoes glucuronidation prior to elimination. Excretion Alendronate Sodium Following a single IV dose of [14C]alendronate, approximately 50% of the radioactivity was excreted in the urine within 72 hours and little or no radioactivity was recovered in the feces. Following a single 10 mg IV dose, the renal clearance of alendronate was 71 ml min 64, 78; 90% confidence interval [CI] ; , and systemic clearance did not exceed 200 ml min. Plasma concentrations fell by more than 95% within 6 hours following IV administration. The terminal half-life in humans is estimated to exceed 10 years, probably reflecting release of alendronate from the skeleton. Based on the above, it is estimated that after 10 years of oral treatment with FOSAMAX 10 mg daily ; the amount of alendronate released daily from the skeleton is approximately 25% of that absorbed from the gastrointestinal tract. Cholecalciferol When radioactive vitamin D3 was intravenously administered to healthy subjects, the mean urinary excretion of radioactivity after 48 hours was 2.4% of the administered dose, and the mean fecal excretion of radioactivity after 48 hours was 4.9% of the administered dose. In both cases, the excreted radioactivity was almost exclusively as metabolites of the parent. The mean half-life of vitamin D3 in the serum following an oral dose of FOSAMAX PLUS D is approximately 14 hours. Special Populations Pediatric: Alendronate pharmacokinetics have not been investigated in patients 18 years of age. Gender: Bioavailability and the fraction of an IV dose of alendronate excreted in urine were similar in men and women. Geriatric: Alendronate Sodium Bioavailability and disposition of alendronate urinary excretion ; were similar in elderly and younger patients. No dosage adjustment of alendronate is necessary see DOSAGE AND ADMINISTRATION and rocaltrol.
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Bisphosphonates 1. Alendonate Fosaamax or Fksamax + D ; Prevention 5mg daily, 35mg weekly; Treatment 10mg daily; 70mg weekly 2. Ibandronate Boniva ; 150mg once monthly or 3mg infusion every 3 months 3. Risedronate Actonel or Actonel with Calcium ; 5mg daily, 35mg weekly 4. Zoledronic Acid Reclast ; 5mg infusion every 12 months and eulexin.
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~ 7wY c: Reproductionstudms in rats showed decreased postimplantationsurvivalat 2 mg kg dey and decreased body weight gain in normal pups at 1 mg kgMey. Sites of incomplete fetal oesifiition were statistically signifiintly increased in rats beginning at 10 mg k day in vertebral oervical, thoracic, end lumbar ; , skull, and etemebrel bones. The above doses ranged from 1 times 1 mg kg ; to 9 times 10 mgkg ; the 10 mg human dose based on surface are% mg ml No shniir fetal effects were seen when pregnant rebbm were treated at doses up to 35 day 50 times the 10 mg human dose based on surface area, mghW ; . Both total and ionii cakium decreased in pregnant rate at 15 m kgMey 13 times the 10 mg human dose based on surface area ; resulting in delays and failures of deliiry. Protracted parturition due to maternal hypocatoemieoccurred in rats at doses as low as 0.5 mg kgMay 0.5 times the recommended human dose ; when rats were treated from before mating through gestation. Maternotoxicii late pregnancy deaths ; oocurred in the female rats treated with 15 mgkg$day for varying periods of time ranging from treatment only during pm-mating to treatment only during eady, middle, or late gestation; these deaths were lessened but not eliminated by cessation of treatment. Calcium supplementationeither in the drinkingwater or by minipump coufd not ameliorate the hypocalcemia or prevent maternal and neonatal deaths due to defays in delive~, calcium supplementationIV prevented maternal, but not fetal deaths. There are no etud- in pregnant women. FOSAMAX should be used during pregnancy only if the potentiafbenefii justifks the potentialrisk to the mother and fetus. Nursing Mothem It is not known whether aiendmnate is excreted in human milk. Seceuse many drugs are excreted in human milk caution should be exercised when FOSAMAX is administeredto nursingwomen. Pedlwrk use Safety and effectiveness in pediitric patients have not been estabiiihed. Use in the Ek4wfy Of the patients reoeiving FOSAMAX in the two large oeteopomsis treatment studies and Pagets disease studies see CLINICAL PHARMACOLOGY, Clinical Studies ; , 45% end 70?!, respectively, were 65 years of age or over. No overall diierences in effii or safety were observed between these patients and younger petknts but greater sensitivityof some older indiiuals cannot be ruled out. lJsein Men Safety and effectiveness in mafe osteoporosishave not been estabiiihed.
People who visit their GP with the flu-like symptoms described above may not in fact be suffering from flu. This is because a variety of other illnesses caused by viruses can result in similar symptoms. People who are otherwise healthy and have flu-like symptoms are advised not to visit their GP. Instead they are advised to stay at home and take medicines from the chemist pharmacist ; to relieve their symptoms. The NHS advises people who are considered at-risk of complications from flu to be immunised against the flu virus often referred to as having a `flu-jab' and avodart.
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Answer: You pose a very difficult question, and there are no clear-cut answers at this time. What is known is that the risk of developing ONJ with oral forms of bisphosphonate medications, such as Fisamax alendronate ; , Actonel didronel ; , or Boniva ibandronate ; , is very low. Estimates range from one per 2, 000 to one per 8, 000 patients using these drugs. However, the risk of ONJ increases slowly with time and total dose. The majority of the problem ONJ cases have occurred in cancer patients who take high doses of bisphosphonates intravenously, and most have developed in patients who have had a surgery that exposes a portion of the jaw to the oral fluids, such as tooth extraction. Given your current situation, your physician is responsible for managing your osteoporosis. He or she should be made aware that you have dental implants and may need future implants. Since most experts agree that the risk from oral drugs becomes measurable between two to three years after starting treatment, you may have time to have additional implant surgeries.
ASSESS BASELINE BONE MINERAL DENSITY BY DXA SCAN If T- score at the total hip and or total spine is 2.5 start treatment with a bisphosphonate Ref 1 ; e.g. risedronate Actonel ; 35mg once weekly or alendronate Flsamax ; 70mg once weekly for at least 5 years. If the T- scores at either of the above sites are between 2.5 and 1.0 and the patient has had a fracture, most specialists would treat with a bisphosphonate. However some would watch and review in 12 months. Nursing home patients under active medical management and those to whom BMD is unavailable should receive calcium, Vitamin D and or bisphosphonates without further investigation and uroxatral.
Fosamax, another medication used to treat the same conditions as Actonel, will continue to be available on the State Health Plan Preferred Drug List for a copay for up to a 34-day supply and will continue to be covered without requiring a coverage review. Generic drug savings: Beginning in early 2008, generic alternatives to Fosamax will be available at your local drugstore. Generic drugs that have been approved by the U.S. Food and Drug.
The authors thank Jennifer Katzer for her assistance with the conduct of the study and Carolyn Hustad and Denise Stek for help with manuscript preparation and submission. The authors also thank the following members of the FACT scientific advisory committee for their contributions to the conduct of the study and the interpretation of the data: Henry Bone, Susan Broy, and Paul Miller. The following investigators participated in the Fosamax protocol 21110 study: R. Ackerman, West Palm Beach, FL; S. L. Aranoff, A. L. Brodsky, B. Cohen, Dallas, TX; A. M. Babbitt, South Portland, ME; D. W. Baldwin, Palo Alto, CA; M. K. Beard, Salt Lake City, UT; N. Binkley, Madison, WI; C. A. Birbara, Worcester, MA; H. G. Bone, Detroit, MI; S. L. Bonnick, Denton, TX; V. J. Bray, Denver, CO; R. B. Brewer, Bloomington, IN; S. B. Broy, Morton Grove, IL; S. Burnett, J. S. Finkelstein, P. Kiel, Boston, MA; S. F. Cosman, West Haverstraw, NY; R. D. Emkey, Wyomissing, PA; R. E. Ettlinger, Tacoma and flomax.
Dominic Caruso - Johnson & Johnson - VP of Finance and CFO With respect to DES penetration, our estimates are that in the first quarter, Larry, the DES penetration was in the mid '60s. In terms of growth rates for the remainder of the year, we actually see total PCI procedure actually declining year-over-year in the low single digit rate and we have taken those into consideration in updating our guidance for the year.
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Table VIII.52. Special Considerations for Cholesterol Management in African Americans Risk Level CHD and CHD risk equivalents 10-year risk 20% LDL Goal 100 mg dL Multiple 2 + ; risk factors 10-year risk 1020% LDL Goal 130 mg dL Multiple 2 + ; risk factors 10-year risk 10% LDL Goal 130 mg dL 01 risk factor 10-year risk 10% LDL Goal 160 mg dL Special Considerations and urispas and Buy fosamax.
Relax rule 2 visits a day would: + allow greater tourist access + generate more park revenues + be an alternative to increasing group size but would also imply: - more disturbance to gorillas & habitat - more exposure to diseases - logistical feasibility a question of disturbance to gorillas rather than disease transmission risk 3 ; one could imagine 2 visits per day without the gorillas suffering for gorilla groups of 20 or more, we could have 2 visits a day two hours apart more than one visit day would interrupt feeding, interactions with other gorilla groups, and travel, which could have great implications for normal social and ecological aspects of gorilla life.
Hormone replacement therapy is a first-line preventive therapy in postmenopausal women with low bone density. However, when used only for the prevention of postmenopausal osteoporosis, the risks of HRT may outweigh the benefits. Bisphosphonates alendronate eq fosamax postmenopausal women or men osteoporosis vertebral compressive or hip fracture and serum creatinine or 1.6mg dl calcitonin raloxifene D3 and casodex.
Such as tetracycline to measure tissue growth. Static histomorphometry involves determining the size and types of cells; measurements include length, area or cell counts. Static histomorphometry involves embedding bone in a resin then sanding the specimen down until it is very thin 150 microns ; and the images are viewed under microscope at various magnifications. Although bone histomorphometry is considered an important tool, it is not always feasible because it requires taking surgically removed bone specimens from willing participants. In this section, prevention and treatment interventions for bone health after a SCI are discussed. As bone loss is greatest immediately following a SCI, pharmacological and non-pharmacological interventions are classified as either prevention the participants are less than 1 year post SCI ; or treatment study involved participants who are 1 year after the injury ; . The intent is to address two distinct clinical questions: 1.What is the best way to prevent acute regional declines in bone mineral density?; and 2. What are the best treatments for low bone mass of the hip and knee region for people with longstanding SCI? 9.4 Pharmacologic Therapy: Bisphosphonates Within weeks after SCI, there is a marked increase in bone resorption taking bone away ; with a decrease in bone formation adding new bone ; and this is responsible for the significant loss in BMD. Bisphosphonates are a group of medications that are used to prevent declines in bone mass or treat low BMD; they act to slow down excessive bone resorption. Etidronate Didrocal ; , Alendronate Fosamax ; and Risedronate Actonel ; are oral bisphosphonates, which are currently approved for the treatment of postmenopausal osteoporosis in Canada Brown et al. 2002 ; . Clodronate Benefos or Ostac ; is available intravenously IV ; and orally for the treatment of osteoporosis. Tiludronate Skelid ; is available in oral form in the United States. Giving calcium and vitamin D at the same time as bisphosphonate therapy has the potential for greater efficacy for bisphosphonates. Concurrent supplementation with calcium and vitamin D have been important additions to bisphosphonate therapy for other medical conditions such as postmenopausal osteoporosis ; Brown et al. 2002 ; . 9.4.1 Pharmacologic Therapy: Prevention within 12 months of injury ; Table 9.2 Prevention Studies using Pharmacology for Bone Health after a Spinal Cord Injury.
S evista and forteo, merck & co' s fosamax and procter & gamble co' s actonel may prevent fragility fractures if the disease is diagnosed early, bloomberg eli lilly q4 profit surges on lower charges, higher sales, volume.
What are the possible side effects of FOSAMAX? Some patients may get severe digestive reactions from FOSAMAX. See "What is the most important information I should know about FOSAMAX?" ; These reactions include irritation, inflammation, or ulcers of the esophagus, which may sometimes bleed. This may occur especially if patients do not drink a full glass of water with FOSAMAX or if they lie down in less than 30 minutes or before their first food of the day. Esophagus reactions may get worse if patients continue to take FOSAMAX after developing symptoms of an irritated esophagus.
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Survival other Median EFS 11 mo Median OS 19 mo 67% grade IV neut w 1 cycle median duration 3 d ; Infections: grade 3 17% Grade 4 9% Neutropenic infection 2 deaths Thal d c `d for thromboembolic event 1 Cerebrovascular event 3 Pt choice 1 Not documented 3 Median time to response 12.4 wk 4-114 ; Median PFS by KM 5.5 mo CI, 3.6-6.8 mo ; Median OS by KM 14.6 mo CI, 9.7 to 26.3 mo ; KM Estimated for 1-year: PFS 23 % CI, 14-34% ; OS 56% CI, 44-67% ; Median survival: 65 yr 6.7 mo 65 yr 4.1 mo.
Historically, a number of risk factors have been cited for osteonecrosis of the jaw, most notably head and neck radiotherapy, but also periodontal disease, dental procedures involving bone surgery, edentulous regions, and trauma from poorly fitting dentures. in 2003 the first published reports of bisphosphonate-associated osteonecrosis BON ; of the jaw began to surface. at that time, the reports were only associated with intravenous bisphosphonates--including pamidronate aredia ; , clodronate Bonefos ; , and zoledronic acid Zometa ; --used to treat cancer patients and patients with Paget's disease. a significant number of the patients had undergone recent dental procedures. in 2004, cases of BON were reported in patients taking oral nitrogen-containing bisphosphonates for the treatment of osteoporosis. Examples of such medications include: risedronate actonel ibandronate Boniva etidronate Didronel alendronate Fosamax Plus D and tiludronate skelid.
Our five key growth drivers [zocor, vioxx, cozaar hyzaar, fosamax and s ingulair], which had increased sales of nearly 30% over the first nine months of 2000 and now account for two-thirds of merck's worldwide human health sales, continued to lead merck's income growth.
Alendronate brand name: fosamax ; and risedronate brand name: actonel ; are not hormones, but are used to help prevent and treat osteoporosis.
Concomitant use with estrogen hormone replacement therapy In two studies of one and two years' duration ; of postmenopausal osteoporotic women total: n 853 ; , the safety and tolerability profile of combined treatment with FOSAMAX 10 mg once daily and estrogen progestin n 354 ; was consistent with those of the individual treatments. Other studies with FOSAMAX Prevention of osteoporosis in postmenopausal women The safety of FOSAMAX 5 mg day in postmenopausal women 40-60 years of age has been evaluated in three double-blind, placebo-controlled studies involving over 1, 400 patients randomized to receive FOSAMAX for either two or three years. In these studies the overall safety profiles of FOSAMAX 5 mg day and placebo were similar. Discontinuation of therapy due to any clinical adverse experience occurred in 7.5% of 642 patients treated with FOSAMAX 5 mg day and 5.7% of 648 patients treated with placebo.
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