Today’s Top Story
Study: Romosozumab followed by alendronate may reduce risk of fracture for postmenopausal women with osteoporosis.
Findings from a study published online in The New England Journal of Medicine suggest that romosozumab treatment for 12 months followed by alendronate may reduce risk of fracture compared to alendronate alone for postmenopausal women with osteoporosis. The authors conducted a randomized, blinded, prospective study of 4,093 postmenopausal women with osteoporosis and a fragility fracture who were assigned to receive monthly subcutaneous romosozumab (210 mg) or weekly oral alendronate (70 mg) for 12 months, followed by open-label alendronate in both cohorts. At 24-month follow-up, 198 patients (9.7 percent) in the romosozumab-to-alendronate group and 266 patients (11.9 percent) in the alendronate-to-alendronate group had experienced clinical fractures. Overall, the authors found a 48 percent reduction in risk of new vertebral fracture, a 19 percent reduction in risk of nonvertebral fracture, and a 38 percent reduction in risk of hip fracture in the romosozumab-to-alendronate group compared to the alendronate-to-alendronate group. The authors note that during the first year of treatment, positively adjudicated serious cardiovascular adverse events were more likely with romosozumab than with alendronate.
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Other News
FDA panel recommends warning regarding gadolinium-based contrast agents in MRI.
Medpage Today reports that the U.S. Food and Drug Administration Medical Imaging Drugs Advisory Committee has voted in favor of a new warning for gadolinium-based contrast agents (GBCAs) used in magnetic resonance imaging (MRI). Published research has suggested evidence of a link between GBCAs and nephrogenic systemic fibrosis in kidney patients, and recent studies have found that patients without impaired renal function may also show deposits of gadolinium. Committee members voted 13-1, with one abstention, to recommend that FDA issue a new warning for GBCAs, and unanimously voted to recommend that the agency consider requiring industry to conduct more research to help determine if regulatory action may be necessary. The advisory committee findings are currently under consideration, and FDA has not yet issued a formal warning.
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Study: Infrapatellar and suprapatellar nailing offer similar sepsis rates for open tibia fracture.
A study published online in the Journal of Orthopaedic Trauma finds no significant difference in the rate of knee sepsis with infrapatellar or suprapatellar nailing of open tibia fracture. Members of the research team conducted a retrospective, multicenter trial of 282 adult patients (289 fractures) treated with medullary nailing for open diaphyseal tibia fracture. Infrapatellar nailing was used for 142 fractures and suprapatellar nailing was used for 147 fractures. At minimum 12-week follow-up, there were 20 infections (14.1 percent) in the infrapatellar cohort, of which 14 (9.8 percent) were deep, compared to 24 infections (16.2 percent) in the suprapatellar cohort, of which 16 (10.8 percent) were deep. Overall, 14 tibias in each group required reoperation for noninfectious reasons. The research team noted zero cases of knee sepsis after infrapatellar nailing and two cases of knee sepsis after suprapatellar nailing.
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Study: Antiepileptic drugs may increase fracture risk in pediatric patients.
According to a pilot study published online in the journal Epilepsia, antiepileptic drugs (AEDs) may be linked to increased risk of fracture in younger patients. The authors conducted a case control study of 46 patients aged 5 to 18 years, 23 of whom had at least 12 months of AED exposure. They found 15 fractures across eight patients in the AED group, compared to four fractures across three patients in the control group. In addition, the authors noted that trabecular volumetric bone mineral density measured by peripheral quantitative computed tomography at the 4 percent site (tibia) was reduced by 14 percent in the AED cohort compared to controls. The authors noted no differences across cohorts in either balance measures or bone mineral parameters measured by dual energy X-ray absorptiometry.
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California.
A post on the California Medical Association website looks at a lawsuit that could impact the independence of hospital medical staffs. At issue is a case in which the board of directors of a medical center voted to terminate the hospital’s medical staff organization, install a slate of appointed officers, and approve new medical staff bylaws and rules drafted without staff input. According to the complaint, the rest of the staff was then terminated and granted provisional status as part of the new medical staff, along with a provision, since amended, that physicians could achieve and maintain active status by proving their economic value to the hospital—an arrangement the plaintiffs have referred to as “an illegal kickback scheme.” Closing arguments are scheduled for Oct. 2, with a ruling expected in 45 to 60 days.
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Vermont.
The Washington Post profiles efforts by Vermont to apply its bundled payment model to 70 percent of insured state residents by 2022. The state hopes to limit the growth in overall annual healthcare spending to 3.5 percent each year. Critics of the program argue that it may punish providers for failing to impact deep-rooted habits and behaviors of patients.
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Call for volunteers: Exhibits Committee.
Oct. 23 is the last day to submit your application for a position on the Exhibits Committee (two member openings). This committee organizes and develops new initiatives for Academy technical exhibits at the AAOS Annual Meeting. Applicants for this position must be active fellows, associate members orthopaedic, associate members osteopathic, or international members with experience developing education programs and cultivating relationships with industry.
Learn more and submit your application…(member login required)
