In November 2008, the Food and Drug Administration reported that based on its review of the data from clinical trials involving nearly 40,000 patients treated with alendronate (Fosamax), ibandronate (Boniva), risedronate (Actonel),
zoledronic acid (Zometa), or placebo, there is "no clear association" between the use of drugs in this class and the rate of serious or nonserious atrial fibrillation.
Based on product type, the market has been segmented into Bisphosphonates (Clodronate, Etidronate, Ibandronate, Pamidronate and
Zoledronic acid), Calcitonin, Glucocorticoids, Denosumab and Calcimimetics.
The study showed that women treated with 5 milligrams (mg) of
zoledronic acid had increased levels of a substance that is a negative regulator of bone formation, and that markers of bone formation and bone resorption were lower.
In a 2-year double-blind study conducted in Europe, South America, Africa, and Australia, 553 men with osteoporosis were randomly assigned to receive once-yearly infusions of 5 mg of
zoledronic acid and 574 were assigned to receive placebo infusions.
The
zoledronic acid treatment led to an average 15-point drop in pain (on a visual analog scale of 0-100) beyond what occurred in the placebo group, and the active treatment was also linked with an average 170-[mm.sup.2] reduction in maximal bone marrow lesion (BML) area beyond the placebo-treated patients, which was a cut in BML area of about 37%, compared with the starting BML area, Dr.
One of them recommended IV
zoledronic acid; the other, denosumab (TABLE, page 12).
Professor Gareth Morgan, of The Institute of Cancer Research, London, UK, and Professors Walter Gregory and Anthony Child, of Clinical Trials Research Unit at University of Leeds compared
zoledronic acid against a similar drug, clodronic acid in a group of almost 2,000 patients.
In men with CRPC and bone metastases,
zoledronic acid (4 mg intravenously) every 3 to 4 weeks is recommended to prevent disease-related skeletal complications, including pathological fractures, spinal cord compression, surgery or radiation therapy to bone.[sup.26,27] Level 1 Evidence, Grade A recommendation
Bisphosphonates, which include alendronate (Fosamax), risedronate (Actonel),
zoledronic acid (Reclast), and ibandronate (Boniva) are recommended as the initial treatment.
Investigators in New Zealand recently published the results of a randomized controlled trial they conducted to determine the efficacy of zoledronate (
zoledronic acid) in preventing fractures in postmenopausal women.
Under the company's Phase 3 '482 study, XGEVA met the primary endpoint, demonstrating non-inferiority to
zoledronic acid in delaying the time to first on-study skeletal-related event in patients with multiple myeloma.