Reclast for Osteoporosis  side effects, danger, benefits and Paget's Disease
May 10 2018 by
Ray Sahelian, M.D.

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 treatment and prevention
A 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.

Use in males
J Endocrinol Invest. 2014. The effect of zoledronic acid on the fracture risk in men with osteoporosis. Prospective, placebo-controlled, double-blind, randomized studies on osteoporosis treatment with bisphosphonates in men are rare. This review focuses on a recent trial and compares the results with other studies. This review provides a summary of recent literature on fracture risk in men following treatment with Reclast. According to a recent clinical study with 1,199 men, zoledronic acid was linked to a lower risk of vertebral fractures. In this manuscript, a re-analysis of the presented statistical data will be demonstrated by performing a Bonferroni-correction to adjust for type 1 error accumulation in multiple statistical tests. It will be shown that the provided evidence linking zoledronic acid to a lower fracture risk in male osteoporosis is true, but less pronounced than originally assumed. Comparative clinical studies are recommended, where the benefits of different bisphosphonates are compared to each other under the same experimental conditions.

Reclast side effects, danger
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. The drug raises the risk for kidney disease and failure.

J Pharm Practice. 2016. A Case of Severe, Prolonged, Refractory Hypophosphatemia After Zoledronic Acid Administration.

Implant Dent. 2015. Medication-related osteonecrosis of the jaws from once per year intravenous zoledronic acid Reclast) report of 4 cases. Because of patient's noncompliance of the antiresorptive medications, which may require once-weekly or once-monthly oral ingestion, a once a year intravenous (IV) infusion of zoledronic acid was introduced in the management of osteoporosis. Reports of medication-related osteonecrosis of the jaw (MRONJ) have been reported in patients with cancer treated with multiple doses of IV zoledronic acid. However, there is a paucity of reports occurring with the once-yearly infusion of zoledronic acid Reclast for the management of osteoporosis. In this article, we report 4 cases of patients who had a history of long-term oral antiresorptive therapy and now were taking the once-yearly IV zoledronic acid (Reclast) and soon developed MRONJ after completing surgery of the maxilla and mandible.

Testimonial received 2017
I am a family practitioner in nh and have a patient who is having severe debilitating side effects from Reclast. She has bone pain, burning, numbness and fatigue. She hasnít been able to tolerate medications to help alleviate this and/or they havenít worked. Do you have any recommendations for referral to a specialist treat this or medication supplements? She has seen 2 neurologists without any benefit.
   A. I am not yet aware of natural supplements that have been studied as a treatment for the side effects from Reclast.

Ever so glad to be alive! Talk about having to learn a lesson the hard way!

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.

My Mother had a Reclast Injection in 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.

I am interested in your research of Reclast side effects. My mother has a very complex health hx of back and hip pain. She also has only one functioning kidney. She is now having very extreme pain, her kidney function is suffering and they are now thinking she has some significant calcium deposits in her lower spine, hip and pelvic regions. Have you came across calcium deposits being a side effect of this medication? Thank you for any consideration you give to this and please feel free to contact me back if you have any further questions.
    I have not studied the adverse effects of this drug in enough detail to know as of December 2009.

Noticed on your entry regarding Reclast side effects. My Aunt is having problems with numbness around eyes; burning cheeks, numbness around mouth, as a result of the Reclast treatment. She has a heart condition; stroke; takes blood thinners, and Dr. has prescribed this bone medication. I have noticed law suits regarding the use of this drug on TV.