Once-Yearly Treatment for Osteoporosis
Excellent news on the osteoporosis front:
An experimental treatment for bone-thinning osteoporosis appears to prevent spine and hip fractures even though it is given only once a year, eliminating the need for a strict daily pill regimen, preliminary data show.
Reclast, given as an annual, 15-minute infusion, reduced risk of new spine fractures by 70 percent and of hip fractures by 40 percent, according to data supplied by maker Novartis Pharmaceuticals Corp. The drug, chemically known as zoledronic acid, also reduced the risk of fractures elsewhere, according to a just-completed, international study of 7,736 postmenopausal women with osteoporosis.
Side effects* were generally minor and short-lived, said Novartis, of East Hanover, N.J.
Lead researcher Dennis Black, a professor of epidemiology at University of California-San Francisco, said that like Fosamax and other pills, Reclast slows down the speed at which cells called osteoclasts break down bone while other cells build it back up.
"If you take Fosamax every week for a year, you'll get a similar effect on bone density," Black said.
He noted that Reclast is part of a decade-long trend of researchers developing osteoporosis drugs taken less and less frequently: Some pills are taken only once a month, and one drug is available as a shot every three months.
Dr. Thomas Cavalieri, director of the New Jersey Institute for Successful Aging, said Reclast will be very significant, if approved, because many osteoporosis patients stop taking their medicine in the first year. One reason is that the pills can cause irritation and ulcers in the esophagus; to limit that, people must take them first thing on an empty stomach, with a large glass of water, then stay upright for 30 to 60 minutes.
That could make nursing home residents and patients with acid reflux disease, among others, good candidates for the shot.
Reclast is in the same category of osteoporosis drugs, bisphosphonates, as Fosamax from Merck & Co. of Whitehouse Station, N.J.; Actonel by Procter & Gamble Pharmaceuticals of Cincinnati; and Boniva from Hoffmann-La Roche Inc. of Nutley, N.J. Another drug, Forteo from Eli Lilly & Co. of Indianapolis, is a form of human parathyroid hormone and must be injected in the thigh or abdomen daily.
In the study, the overall incidence of adverse events experienced with Aclasta were comparable to placebo. The study included a careful examination of key safety parameters, including kidney and jaw safety, which found Aclasta to be comparable to placebo. The most common adverse events associated with intravenous infusion of Aclasta were the following post-dose symptoms: fever, muscle pain, flu-like symptoms, headache and bone pain. The majority of these occurred within the first three days following Aclasta administration and were resolved within the first three days of the event onset. The incidence decreased markedly with subsequent doses of Aclasta.
Aclasta is being studied in a series of multi-national and multi-centre clinical trials called HORIZON - one of the most comprehensive drug evaluation programs ever undertaken in the area of metabolic bone diseases. This clinical development program involves once-yearly dosing with Aclasta for osteoporosis. It also includes studies in the prevention of clinical fractures following a hip fracture in men and women, male osteoporosis, corticosteroid-induced osteoporosis, prevention of osteoporosis, treatment of Paget's disease of the bone, and treatment of osteogenesis imperfecta in children. Approximately 13,000 patients have participated in the ongoing HORIZON program in more than 400 trial centers worldwide.
Aclasta has been approved in approximately 50 countries , including the EU and Canada, for the treatment of Paget's disease. The FDA issued an "approvable letter" for this product, under the proposed trade name Reclast, for the treatment of Paget's disease of the bone in February 2006. The FDA requested additional data from the ongoing clinical trial program in osteoporosis. Novartis is working with the FDA to gain approval for this indication. Zoledronic acid, the active ingredient of Aclasta, is also available under the brand name Zometa for use in other indications.