There is exciting news in the field of osteoporosis. A new medication was FDA approved last month. Is this medication right for you?
A novel approach for the treatment of osteoporosis has just been approved by the FDA. It is called Reclast (Zoledronic acid). This revolutionary medication is a once a year, 15 minute infusion, which will allow the easiest available intake of an osteoporosis medication, with excellent efficacy, and a good safety profile.
Over the years, patients have had concerns with the oral bisphosphonates (Fosamax, Actonel and Boniva). These included possible stomach side effects and significant restrictions in the ways that they need to be taken. These older medications must be taken every day, week, or month, first thing in the morning, with a plain glass of water, remaining upright and without any other food for 30 minutes to 1 hour. This regimen has remained difficult for many patients and many are looking for alternative options.
The most recent available alternatives include Forteo and IV Boniva. However, Forteo is a daily injection and Boniva has been somewhat limited by its lack of FDA approval for hip fractures. Reclast has been shown to reduce the occurrence of osteoporosis fractures of the hip, spine and non-vertebral areas.
This is not entirely a new drug. It has been on the market for bone cancer patients for the past 5 years and has been extensively used.
There are some mild associated side effects with receiving the infusion. These include fever, fatigue and muscle aches and can be reduced with the use of Tylenol prior to and after the infusions.
There is also the concern about Osteonecrosis of the jaw (ONJ). This has been reported in patients taking bisphosphonates including Reclast. Most cases have been cancer patients undergoing dental procedures. A thorough dental exam should be done prior to the administration of Reclast. Risk factors are cancer, chemotherapy, corticosteroids, and poor oral hygiene. Typically, when this condition, ONJ was discovered, it was when patients received the infusion every 3-4 weeks in the standard cancer dose. This would equal to a dose 10-14 times higher then the yearly dose of IV Reclast.
Another concern is regarding the risk of a heart rhythm abnormality (atrial fibrillation). In their trial published this year in the New England Journal of Medicine, there appeared to be a small (<1%) increase over placebo. However, there is some question whether this was due to the drug, as this was never seen in any of the other many trials or any previous post marketing data of the cancer dose of the drug.
In conclusion, this new drug may be an option for anyone who is intolerant, unable to take any of the oral osteoporosis medications, or is looking for a more efficacious agent due to severe disease. One must, as always, discuss this with their physician or health care provider and determine the proper therapy for them.
The author has no affiliations and has not received any honorarium or funding from with Novartis, the company producing and marketing IV Reclast.
Published On: September 13, 2007