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Treatment of Osteoporosis in Postmenopausal Women: Zoruxa is indicated for treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, diagnosed by bone mineral density (BMD) or prevalent vertebral fracture, Zoledronic acid reduces the incidence of fractures (hip, vertebral and non-vertebral osteoporosis-related fractures). In patients at high risk of fracture, defined as a recent low-trauma hip fracture, Zoledronic acid reduces the incidence of new clinical fractures.
Prevention of Osteoporosis in Postmenopausal Women: Zoruxa is indicated for prevention of osteoporosis in postmenopausal women.
Osteoporosis in Men: Zoruxa is indicated for treatment to increase bone mass in men with osteoporosis.
Glucocorticoid-Induced Osteoporosis: Zoruxa is indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who are expected to remain on glucocorticoids for at least 12 months.
Paget's disease of Bone: Zoruxa is indicated for treatment of Paget's disease of bone in men and women. Treatment is indicated in patients with Paget's disease of bone with elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, or those who are symptomatic, or those at risk for complications from their disease.
Important Limitations of Use: The safety and effectiveness of Zoledronic acid for the treatment of osteoporosis is based on clinical data of three years duration. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.
