Increased Bone Mineral Density in Denosumab Data Presented at ENDO 2015


ENDO wrist denosumabExciting news was presented at ENDO 2015 regarding the use of Denosumab for osteoporosis in post-menopausal women who are at high risk for bone fractures. Results from a comprehensive trial coined Freedom showed the use of Denosumab successfully increased bone mineral density (BMD) at cortical bone sites, particularly the 1/3 radius skeletal site which does not typically respond to osteoporosis treatments. The Freedom trial was documented during 3 years of placebo/Denosumab administration and another 6 years of treatment for patients with Denosumab only. The incidence of wrist fracture and 1/3 radius BMD were examined in 2,207 women. The extended 6 years of data gleaned was deemed the Freedom Extension trial. Of the 2,207 women, all with varying degrees of wrist fracture, not one woman withdrew from the trial due to adverse effects. The female participants also received daily doses of both vitamin D and calcium in addition to either the placebo or Denosumab doses. The participants in the Freedom Extension trial experienced bone loss reversal, which resulted in bone mineral density gains at the 1/3 radius of 1.5 percent. An overwhelmingly positive conclusion was drawn by study investigators that treatment with Denosumab for at least 3 years was able to not only stop, but also reverse bone loss. Additionally, greater than 3 years of Denosumab therapy translated into both gains in BMD as well as lower wrist fracture rates in the future overall. Reversing the cortical bone loss in patients suffering from osteoporosis is key in the prevention of fractures and injuries for this susceptible patient population.

Age and bone massDenosumab, also known as the brand name Prolia, which is marketed by Amgen, is prescribed for women and men at risk for osteoporosis, although the majority of patients using Denosumab therapy are females who are postmenopausal. This drug is in the classification of monoclonal antibodies and there are few adverse effects associated with Denosumab. Commonly reported side effects include constipation, muscle pain and muscle weakness. The typical dosage of Denosumab is 60 milligrams, administered via one subcutaneous injection approximately every 6 months. Patients who are undergoing therapy with Denosumab are usually advised to take 1000 milligrams of calcium daily, as well as 400 IU of vitamin D daily. In addition to women who are at risk of osteoporosis due to menopause Denosumab is also prescribed for the following:

  • Postmenopausal women who are at high risk for fractures, specifically in need of a reduction in risk for vertebral and hip fractures.
  • Women who are at menopause or are postmenopausal and cannot tolerate other forms of treatment for the prevention of osteoporosis.
  • Therapy for women who are at risk of bone loss due to breast cancer therapy with aromatase inhibitors.
  • As a treatment for men who are at risk for osteoporotic bone fractures due to a current diagnosis of osteoporosis or who are at a very high risk of getting osteoporosis.
  • Treating men who have bone loss due to androgen deprivation therapy, as a result of nonmetastatic prostate cancer treatments.

LGM Pharma can assist clients as a supplier/distributor of the API Denosumab, CAS # 615258-40-7 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.

 

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