Reclast's maker, Novartis, is preparing to submit Reclast for FDA approval as an osteoporosis treatment. Meanwhile, Reclast's Phase III studies, the last phase of studies needed for FDA consideration, are in.
The studies lasted three years and included more than 7,700 postmenopausal women with osteoporosis (average age: 73) in 27 countries.
The women either got a 15-minute yearly infusion of Reclast or an infusion containing no medicine (placebo).
Those in the Reclast group were 70% less likely to get new spine fractures and 40% less likely to get hip fractures during the three-year period, compared to those in the placebo group, according to data released by Novartis. Novartis is a WebMD sponsor.
The studies were presented Sept. 16 at the American Society of Bone and Mineral Research's annual meeting in Philadelphia.
Several teams of scientists worked on the studies. They included Dennis Black, PhD, of the University of California, San Francisco.
"The efficacy and safety data show for the first time that women may have the option of a once-yearly treatment for osteoporosis," Black says in a Novartis news release.
The results also show the new drug "effectively protects women against fractures, including those of the hip, which can be devastating," Black says.
Reclast belongs to a class of osteoporosis drugs called bisphosphonates, which curb bone loss.
Currently, bisphosphonate drugs can be taken by mouth once weekly (such as Fosamax and Actonel) or once monthly (Boniva). Boniva is also available as an intravenous infusion given every three months.
Reclast's active ingredient is zoledronic acid, which Novartis includes in Zometa, a drug used to treat cancer-related bone problems.
Another study presented at the meeting tracked side effects of Reclast and Fosamax in 225 postmenopausal women with low bone-mineral density.
In the one-year study, 113 women got one infusion of Reclast. The other 112 women took Fosamax pills once weekly.
A third of the women in the Reclast group reported side effects within the first three days after treatment, compared to a little more than a fifth of those taking Fosamax.
The main side effects reported in the Reclast group were headache (12%), pain (5%), and fatigue (5%).
Three days after treatment, overall rates of side effects were similar for Reclast and Fosamax, the researchers report.
The researchers also asked 220 of the participants if they would rather take a weekly pill or get a yearly infusion for their osteoporosis. More than three-fourths said they preferred the infusions, the study shows.
SOURCES: American Society of Bone and Mineral Research 28th Annual Meeting, Philadelphia, Sept. 15-19, 2006. News release, Novartis. WebMD Medical Reference: "Understanding Osteoporosis -- Treatment." WebMD: "Drugs and Treatments -- Zometa." WebMD Medical Reference from Healthwise: "Paget's Disease of Bone."
By Miranda Hitti
Reviewed by Louise Chang