Denosumab is Poised to be a Boon to Bone Health


Denosumab, CAS number 615258-40-7, offers divergent options for researchers working with this monoclonal antibody. The scope of efficacy for denosumab is wide, with one of it’s uses being an approved treatment of osteoporosis in women, particularly those women who are post menopausal. Known as the brand Prolia®, which is marketed by Amgen, denosumab is effectively geared for women who are at high risk for fractures or who cannot tolerate other osteoporosis medications. Denosumab is also known as the brand Xgeva®, which is marketed by Amgen as well, and is used to prevent bone fractures in patients with tumors that have spread to the bone. The capabilities of denosumab are varied, showing virtue in the prevention of skeletal-related events in patients with bone metastases from solid tumors, and the ability to slow down the bone-breakdown process in women with osteoporosis.

Studies of denosumab, known as Prolia, indicate that post menopausal women who received the twice a year injections showed marked improvement in both bone density and less fracture incidence. This three year study gleaned information as to how denosumab is thought to work, and it is believed to target a chemical signal called RANK ligand, which is an integral part of the body’s natural process for breaking down bone. Reported side effects from clinical trial participants using Prolia were back pain, high cholesterol levels, urinary bladder infections, rashes, and a higher risk of serious infections.

Denosumab, when taken as the brand Xgeva, is efficacious treatment for patients with cancerous or solid tumors who are at risk for skeletal fractures. It is clearly defined as not being indicated for the prevention of skeletal-related events in patients with multiple myeloma. Administered as a subcutaneous injection of 120 milligrams every four weeks, denosumab is generally well tolerated. Potential adverse effects include hypocalcemia, dyspnea, fatigue and nausea. In May 2011 Amgen revealed great success with Phase 3 trials of Xgeva, and announced a documented rate of bone metastasis-free survival in men with prostate cancer, by administering Xgeva. Xgeva, or denosumab, demonstrated the ability to prevent bone metastases in the men studied, with back pain being the most commonly reported adverse effect.

The FDA has approved denosumab for use in the management of osteoporosis, as well as the prevention of skeletal related events in patients with breast and prostate cancers that have metastasized to the bones. These approvals for both Prolia and Xgeva are only the beginning of exciting research and development underway for denosumab. LGM Pharma works in close collaboration with manufacturers worldwide, and is a preferred supplier of the API denosumab for research and development programs.

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