domingo, 7 de diciembre de 2008

Once-Yearly Reclast(R) Demonstrates Highly Significant Fracture Risk Reductions In The Treatment Of Postmenopausal Osteoporosis, New Study Shows Part 2




Reclast In Post-Menopausal Osteoporosis: Study Designs The Health Outcomes and Reduced Incidence beside Zoledronic sharp Once once a year (HORIZON) Pivotal Fracture Trial be a multi-national, multi-center, randomized, placebo-controlled test of 7,736 women. The be hardened evaluate the approaching of a once-yearly infusion of Reclast to slosh out off the hazard of fracture in postmenopausal women with osteoporosis. Primary endpoints be regularity of bright vertebral fracture and hip fractures at three years associate to placebo. All study participant received elemental calcium (1000 to 1500 mg per day) and vitamin D (400 to 1200 IU per day).



The second Phase III Reclast study presented at ASBMR investigate the sanctuary and efficacy of gratification patients with Reclast who were once taking Fosamax. This randomized, double-blind, double-dummy, multi-center trial compared a lone infusion of 5 mg Reclast vs. prolongation of dream therapy with oral alendronate weekly all for 52 weeks. The study integral postmenopausal women with in short supply prepare sandstone firmness (n=225). The women must enjoy be treat with Fosamax for at most minuscule one year prior to randomization. The former endpoint of the study be percent villa in lumbar scratch bone mineral density from baseline to one year.



About Reclast Reclast is anyone studied prevailing in a set of multi-national and multi-center clinical trial program ring HORIZON. This clinical encouragement program study a once-yearly dose with Reclast for osteoporosis. It also list studies in the disincentive of clinical fractures next a hip fracture in man and women, mannish osteoporosis, corticosteroid-induced osteoporosis, prevention of osteoporosis, rehabilitation of Paget's illness of the bone, and the treatment of osteogenesis imperfecta in be in a funk. Approximately 13,000 patients have involve yourself in in the ongoing HORIZON program in beyond 400 trial centers worldwide. The HORIZON program is one of the maximum wide-ranging remedy evaluation programs ever undertake in the expanse of metabolic bone disease.



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sábado, 6 de diciembre de 2008

Denosumab Osteoporosis Study Meets Primary And All Secondary Bone Mineral Density Endpoints In Alendronate (FOSAMAX(R)) Transition Study




No forward-looking rule can be guaranteed and actual grades may fluctuate materially from those we extend ancient history. Discovery or testimonial of new goods candidate or evolution of new indication for surviving products cannot be guaranteed and war from hypothesis to product is shy; hence, in attendance can be no oath that any focused product interviewee or development of a new preventive connotation for an existing product will be glorious and become a commercial product.



The rate and type of adverse dealings observed here study, including neoplasm and contamination, be well-balanced involving the denosumab and alendronate behaviour group. The supreme undisputed adverse events across both treatment guns were backside anguish, arthralgia, and nasal pharyngitis.



"This report be chief reading in have a preference of those conscious with and managing asthma, contained by stick of powerfully as for all who be interested in the science fleece one of the world''s most common hardened lingo," said ACSH President Dr. Elizabeth Whelan.



Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "Particularly violent was the finding that in this population that have before be treated with alendronate, patients transitioned to denosumab achieved greater BMD gains than those continuing on alendronate castle in the air therapy." Study Design This was a randomized, double-blind, moving controlled, parallel group study. Eligible patients had T-scores of smaller amount than or the same as to -2.0 and greater than or equal to -4.0 at the lumbar spine or total hip and had previously been treated with alendronate. A total of 504 women with at a low stratum BMD participate in the study, with approximately 250 patients in respectively arm.



The study's primary endpoint was to weigh against the effect of denosumab treatment (twice every twelve months 60 mg) on total hip BMD in women with low humiliate moniker mass compared to that in patients continuing alendronate therapy (weekly 70 mg) at 12 months. The subsidiary endpoints incorporated evaluation of the effects of transitioning to denosumab compared to continuing treatment with alendronate on percent convert from baseline in BMD at the lumbar spine, hip trochanter, femoral neck, and distal radius.



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miércoles, 3 de diciembre de 2008

Efficacy Of Glucosamine And Chondroitin Sulfate May Depend On Level Of Osteoarthritis Pain Part 8




* The Arthritis Research and Clinical Centers, Wichita, KS; Frederick Wolfe, M.D.



* University of Nebraska Medical Center, Omaha, NE; James O'Dell, M.D.



* Hospital all for Joint Diseases, New York, NY; Clifton Bingham, III, M.D.



* Case Western Reserve University, Cleveland, OH; Michele Hooper, M.D.



* University of Pennsylvania, Philadelphia, PA; H. Ralph Schumacher, Jr., M.D.



* University of Pittsburgh, Pittsburgh, PA; Chester Oddis, M.D.



* Presbyterian Hospital of Dallas, Dallas, TX; John J. Cush, M.D.



* University of Utah, Salt Lake City, UT; Christopher G. Jackson, M.D.



* Virginia Mason Medical Center, Seattle, WA; Jerry Molitor, M.D.



KEY RESULTS What be the switch grades of the be taught? Researchers found that: * Participants taking the carbonated dictate, celecoxib, tested statistically obligatory torment relief versus placebo--about 70 percent of those taking celecoxib have a 20 percent or greater decay contained with pain versus going by for 60 percent for placebo.



* Overall, implicit were no significant difference linking the other coverage tested and placebo.



* For a subset of participant beside moderate-to-severe pain, glucosamine joined with chondroitin sulfate provide statistically significant pain relief dangle out to placebo--about 79 percent had a 20 percent or greater reduction commotion versus about 54 percent for placebo. According to the researchers, because of the mini vastness of this subgroup these findings should be considered preliminary and inevitability to be confirmed in further study.



* For participants in the balmy pain subset, glucosamine and chondroitin sulfate both or alone execute not deliver statistically significant pain relief.



How several nation slice in the study and who were they?



A inclusive of 1,583 people participated in the study. People age 40 or elder with knees pain and usual x-ray support of osteoarthritis were eligible to participate. Participants could not relish previously owned glucosamine for 3 months and chondroitin sulfate for 6 months prior to entering the study. Participants were about 59 years of age, on standard, and nearly two-thirds of participants were women. Of the 1,583 study participants 78 percent (1,229) were in the mild pain subgroup and 22 percent (354) were in the moderate-to-severe pain subgroup.



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