Reclast for Osteoporosis and Paget's Disease by Ray Sahelian, M.D. side effects and benefits

Reclast is the first once-yearly drug for postmenopausal osteoporosis. It is given in a fifteen minute infusion intravenously. Reclast was approved by the FDA in April, 2007 for Paget's disease, which can result in misshapen bones in one or more areas of the body. Reclast is given by infusion. Its active ingredient, zoledronic acid, is also marketed by Novartis under the brand name Zometa for use in certain cancer patients. Reclast belongs to a class of medications called bisphosphonates, which also includes the osteoporosis drugs Fosamax, which needs to be taken once a week, and Boniva, which needs to be taken once a month. Both are in pill form.

Reclast for osteoporosis
A September, 2007 study published online in The New England Journal of Medicine showed the administration of Reclast led to 28 percent fewer deaths and 35 percent fewer fractures in the group that got a once-a-year infusion of the bone drug compared to those who got placebo. For the study, researchers recruited about 2,000 patients from 23 countries who were not taking oral bisphosphonates. Their average age was 74 and most were women. All had previously broken a hip. Half of the participants received Reclast given in an infusion.
   The research was funded by Novartis, which makes Reclast, and Lyles has two patent applications for the use of the drug. Under the name Zometa, the drug was approved by the U.S. Food and Drug Administration for cancer patients in 2002. It was approved for post-menopausal osteoporosis in August 2007 under the name Reclast. Over the next two years, 139 of the patients in the placebo group had new broken bones, or about 14 percent. Just 92 of the treated patients had second fractures, or about 9 percent. More surprising, 141 died in the placebo group, or about 13 percent, compared to 101 in the treatment group, about 10 percent. The cause of death was never determined for many, including more than half of those who died in the Reclast group. Everyone in the study received vitamin D.

Reclast side effects
Osteonecrosis has been associated with the use of bisphosphonates. Side effects of intravenous Reclast could include heart rhythm abnormalities. In one study, serious atrial fibrillation -- in which the upper chambers of the heart beat rapidly but weakly -- affected significantly more patients in the zoledronate group compared with the placebo group.

Alternatives to Reclast
Fosamax and other bisphosphonates, a class of osteoporosis drugs that stops bone breakdown are often prescribed by doctors. But many patients do not take the pills because they cause heartburn and other symptoms.

Reclast once a year
Zoledronic acid (Aclasta; Reclast), a third-generation nitrogen-containing bisphosphonate, is the first once-yearly treatment to have been approved for use in patients with postmenopausal osteoporosis or at high risk of fracture. Intravenous Reclast zoledronic acid 5 mg once yearly may reduce the risk of several types of fracture in patients with postmenopausal osteoporosis or recent low-trauma hip fracture. improvements in bone mineral density (BMD) and reductions in markers of bone turnover may occur. Reclast zoledronic acid is generally well tolerated. Intravenous reclast zoledronic acid 5 mg once yearly is a convenient treatment option that may have an advantage over some other agents, for which adherence to treatment regimens is a recognized problem.

Questions
My Mother had a Reclast Injection November, 2008 and soon after began experiencing excruciating pain and muscle spasms. As long as she sits still she is fine, any movement and the pain and muscle spasms return. She has lost her appetite and is losing weight. She becomes breathless with any exertion. All her Dr. does is give her pain pills and muscle relaxers which is a temporary solution to a long-term problem. She lives in a small community and I don't think the Dr. is very knowledgeable in this circumstance. My Mother is suffering. We are looking for a specialist or someone other than a neurologist or orthopaedic. They know nothing to do. It is not fair, no one explained the side affects to my mother.