RECLAST APPOVED TO PREVENT OSTEOPORORSIS

June 4, 2009 — The FDA this month has approved zoledronic acid infusion (Reclast, Novartis Pharmaceuticals Corp) for the prevention of postmenopausal osteoporosis during a 2-year period.

"It is very important to treat postmenopausal women with low bone mass to help prevent them from progressing to osteoporosis," said Mone Zaidi, MD, PhD, in a company news release. "The dosing of Reclast for the prevention of postmenopausal osteoporosis offers an advance over existing therapies since it can be given once every two years, instead of daily, weekly, or monthly."

Dr. Zaidi is professor of medicine, geriatrics, and physiology and director of the Mount Sinai Bone Program at Mount Sinai School of Medicine in New York City.

The FDA's approval was based on data from a 2-year, randomized, multicenter, double-blind clinical study (n = 581) showing that zoledronic acid significantly increased bone mineral density at the lumbar spine relative to placebo for osteopenic women in early and late menopause (6.3% and 5.4%, respectively; P < .0001 vs placebo for both). An increase in hip bone mineral density was also observed for both groups (4.7% and 3.2%, respectively; P < .001 vs placebo for both).

The recommended prophylactic regimen of zoledronic acid is a single 5-mg dose every 2 years, administered intravenously during a period of at least 15 minutes. Daily supplementation with 500 to 1200 mg elemental calcium plus 400 to 800 U vitamin D is recommended.

Adverse events most commonly associated with treatment include pyrexia, myalgia, headache, arthralgia, and pain in extremity; other clinically important events were flu-like illness, nausea, vomiting, diarrhea, and eye inflammation. Treatment should be withheld for severe bone, joint, and/or muscle pain.

The FDA warns that zoledronic acid has been linked to a risk for renal impairment that may be elevated in patients receiving concomitant nephrotoxic medications or diuretic therapy and those with severe dehydration. Monitoring of serum creatinine is recommended before each dose.

Osteonecrosis of the jaw has been reported rarely during treatment with bisphosphonates, including zoledronic acid. A routine oral examination is recommended before initiation of therapy.

Zoledronic acid previously was approved for the treatment of osteoporosis to reduce the incidence of hip, vertebral, and nonvertebral fractures in postmenopausal women and to increase bone mass in men.

Other indications include the treatment and prevention of glucocorticoid-induced osteoporosis in patients expected to receive glucocorticoids for at least 1 year and the treatment of Paget's disease of bone in men and women.