EAST HANOVER, N.J. -- The FDA has approved a once-yearly intravenous formulation of zoledronic acid (Reclast) for osteoporosis in postmenopausal women, Novartis announced.
EAST HANOVER, N.J., Aug. 20. -- The FDA has approved a once-yearly formulation of zoledronic acid (Reclast) for osteoporosis in postmenopausal women, Novartis announced.
The drug, administered in a single 15-minute-long intravenous infusion, was already approved for treatment of Paget's disease.
Novartis said the once-a-year dosing schedule allows clinicians to guarantee that women were receiving recommended therapy in a way that "will have a positive impact on the management of this potentially devastating condition."
In a three-year randomized, double-blind, placebo-controlled phase III trial of 7,765 women, the once yearly treatment reduced vertebral fractures by 70%, hip fractures by 41%, and nonvertebral factures by 25%, according to findings reported in the New England Journal of Medicine.
Those results were comparable to oral weekly or monthly bisphosphonate treatment.
However, serious atrial fibrillation occurred more frequently in the zoledronic acid group (in 50 versus 20 patients, P<0.001). (See Once-a-Year IV Drug Scores for Postmenopausal Osteoporosis)
Zoledronic acid is contraindicated in patients with hypocalcemia. The once-a-year formulation contains the same active ingredients as Zometa, so the drug should not be given to patients already being treated with Zometa, said Novartis.
It should not be used in pregnancy because of possible harm to the fetus and is not recommended for patients with creatinine clearance of <35mL/min.
The most common side effects associated with zoledronic acid are fever, musculoskeletal pain or joint pain, flu-like symptoms, and headache. Symptoms usually occur within three days of infusion and resolve in three to four days, but may last for two weeks.
Because osteonecrosis of the jaw has been reported in postmenopausal women taking bisphosphonates, a routine oral examination is recommended before initiating zoledronic acid infusion.