Reclast Failed To Prevent Cartilage Loss In Knee Osteoarthritis: Study
New research suggests the bone drug Reclast may not be effective at preventing prevent cartilage loss among knee osteoarthritis patients, while exposing users to a risk of several known side effects.
Australian researchers published a study in The Journal of the American Medical Association (JAMA) on April 21, which reviewed case data involving patients receiving Reclast, to determine whether the medication significantly impacted the change in tibiofemoral cartilage volume.
Reclast (zoledronic acid) was developed by Novartis and approved by the FDA in 2007, and is given as an injection once a year. It is also sold as Zometa, a monthly cancer drug.
Did You Know? Millions of Philips CPAP Machines Recalled
Philips DreamStation, CPAP and BiPAP machines sold in recent years may pose a risk of cancer, lung damage and other injuries.Learn More
The medication is part of a class of drugs known as bisphosphonates, which are used to treat Paget’s disease, high blood levels of calcium caused by cancer or cancer that has spread from elsewhere in the body to the bone, to treat or prevent osteoporosis in postmenopausal women, and to increase bone mass in men with osteoporosis.
In this latest study, researchers observed a total of 223 patients aged 50 years or older with symptomatic knee osteoarthritis and subchondral bone marrow lesions from November 2013 through September 2015. Some received intravenous infusion of 5mg zoledronic acid while others received a placebo.
Researchers compared the results, looking at cartilage volume loss, however, they found no significantly statistical difference. Furthermore, researchers found those receiving Reclast treatments more commonly experienced adverse acute reactions.
“Among patients with symptomatic knee osteoarthritis and bone marrow lesions, yearly zoledronic acid infusions, compared with placebo, did not significantly reduce cartilage volume loss over 24 months,” the researchers concluded. “These findings do not support the use of zoledronic acid in the treatment of knee osteoarthritis.”
In 2011, the FDA issued a drug safety communication warning about potential kidney failure side effects of Reclast, adding information to the drug label about the importance of monitoring for signs of renal problems. The warning followed at least 11 fatalities linked to acute kidney failure in Reclast recipients.
The warning detailed those most vulnerable to kidney failure from Reclast include individuals who already have a history of kidney problems, those who were severely dehydrated just before or after being prescribed Reclast, and patients using kidney-damaging or diuretic drugs at the same time as they are given Reclast. The FDA also notes that Reclast kidney risks may increase with age.
As a result of the reports, a mandatory warning was added to the label of the medication indicating the risks to those who already have a history of kidney problems, as well as recommendations to be screened and monitored for kidney functions after starting the medication.
More Top Stories
A wrongful death lawsuit filed by the parents of a baby girl who died at only five days old says her fatal case of necrotizing enterocolitis was caused by Similac and Enfamil infant formula products.
A Nebraska man says he developed Parkinson's disease while working as a licensed applicator of Paraquat for nearly 20 years.
Recipients of some recalled Exactech knee and ankle implants will receive letters warning them their implants may be prone to premature wear and failure.