Reclast for Osteoporosis
by Dr. Jeffrey Landis
Lets start with the disease to better understand why treatment is needed. Osteoporosis is a disease, usually of the elderly, where increased bone weakness increases the risk of a broken bone. Bones that commonly break include the vertebrae in the spine, the bones of the forearm, and the hip. Until a broken bone occurs, there are typically no symptoms. Bones may weaken to such a degree that a break may occur with minor stress or spontaneously.
Hip fractures can lead to decreased mobility and other complications like a fatal blood clots and pneumonia. The six-month mortality rate following hip fracture is around 13.5% and the twelve-month mortality is around 20-30%. A year after fracturing a hip, 90 percent of those who needed no assistance climbing stairs before the fracture will not be able to climb five stairs; 66 percent won't be able to get on or off a toilet without help; 50 percent won't be able to raise themselves from a chair; 31 percent won't be able to get out of bed unassisted; and 20 percent won't be able to put on a pair of pants by themselves.
Vertebral fractures, while having a smaller impact on mortality, can lead to a severe chronic pain from nerve compression. Vertebral fractures can lead to deformity of the spine. Multiple vertebral fractures can lead to such a severe hunch back that the resulting pressure on internal organs can impair one's ability to breathe.
The U.S. Preventive Services Task Force recommends that all women 65 years of age or older be screened for osteoporosis. A DEXA scan is considered the gold standard for the diagnosis of osteoporosis. Osteoporosis is diagnosed when the T-score is less than or equal to -2.5. The need to treat the osteoporosis is based on a FRAX score. This score is calculated based on risk factors, age, sex, weight, height, race, and bone mineral density. The current National Osteoporosis Foundation Guide recommends treating patients with FRAX 10-year risk scores of > or = 3% for hip fracture or > or = 20% for major osteoporotic fracture, to reduce their fracture risk.
Osteoporosis treatment usually starts with an oral bisphosphonate, but this may not be well tolerated due to severe reflux or declining T-scores due to poor gastrointestinal absorption. Reclast (also called zoledronate or zoledronic acid), is an IV bisphosphonate used to treat a number of bone diseases including osteoporosis, high blood calcium due to cancer, bone breakdown due to cancer, and Paget’s disease. The infusion takes about 20-30 minutes. Reclast is given yearly for 3-6 years for osteoporosis depending on the severity of the osteoporosis. This is followed by a 1-2 year holiday to prevent abnormal fractures in the hip and shoulder. Reclast is given once for Paget’s and is usually curative.
Reclast is contraindicated in renal failure and patients with low calcium levels. Blood tests must be done prior to the infusion to assure safe use of the medication. Use during pregnancy will likely result in harm to the baby. It's half life is so long that it should not be used in women of reproductive age.
The most common adverse reactions to Reclast (greater than 10%) were fever, muscle pain, headache, and joint pain. Other important adverse reactions (5-10%) were flu-like illness, nausea, vomiting, and diarrhea. Another rare complication that has been observed in cancer patients being treated with bisphosphonates is osteonecrosis of the jaw. This has mainly been seen in patients with multiple myeloma treated with Reclast who have had dental extractions.
So, if you have osteoporosis, and you don’t get it treated, there is a good chance you will fracture a bone. That fracture can lead to death or permanent placement in a nursing facility. If you get Reclast, it’s an easy infusion that is 20-30 minutes once a year and you decrease your chances of breaking a bone that could lead to your death or permanent placement in a nursing facility. That is why Reclast is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system.