Denosumab Enhances the Density of Bones and Decreases Fracture Risk for Prostate Cancer Survivors
The first research that studies the effects of twice-yearly applied denosumab treatment is going to be released in the August issue of the New England Journal of Med, but for those interested it can be retrieved earlier from the Internet. This study focuses on how the treatment with denosumab, drug which increases the density of the bones by stopping the bone loss, can bring positive effects for men who are treated from prostate cancer through an androgen-deprivation therapy. Through the treatment with the hormone-blocking therapy, the risk of spine fracturing of the prostate cancer patients is prevented and even decreased.
Medical doctor Matthew Smith from the Massachusetts General Hospital Cancer Center led the team of scientists who underwent the study as being a piece of the Denosumab HALT Prostate Cancer Study Group. Researchers and authors that aided the evolution of the study were: Benjamin Leder from the Endocrinology department from Massachusetts General Hospital, Blair Egerdie from the Kitcher Urology Associates, Narciso Hernandez Toriz from the Centro Medico Nacional Siglo XXI in Mexic, Robert Feldman doctor at the Connecticut Clinical Research Center, Tuevo Tammela from Finland`s Tempere University Hospital, Fred Saad, doctor at Central Hospital of the University of Montreal, Jiri Heracek from Androgeos, Prague, Maciej Szwedowski, doctor from Wojewodzkie Centrum Medyczne, Poland, Chunlei Ke, Amy Kupic and Carsten Goessl from Amgen Incorporated. The costs incurred by the study were funded by an Amgen grant and support from the National Institutes of Health and the Prostate Cancer Foundation.
When questioned about their research, Doctor Matthew Smith stated: “Androgen-deprivation therapy is the standard treatment for men with locally advanced, recurrent and metastatic prostate cancer; but many active men who have been successfully treated for their cancer develop debilitating bone fractures as a result. The results of this study should be critically important in improving the quality of life of thousands of prostate cancer survivors.”
There are two million people in the United States who managed to survive the prostate cancer. They are receiving the androgen-deprivation therapy that stops testosterone being released by the glands. Many treatments for counteracting osteoporosis such as giving bisphosphonates drugs have been proven to show some positive effects in reducing androgen-deprivation causing the bone loss in men. This was concluded by earlier research, but the clinical trials were inadequate in proving that these drugs could also prevent or decrease the cases of fractures. Denosumab is a monoclonal antibody which blocks the activity of the osteoclasts which represent cells that destroy the bones during the healthy process or remodeling the bone tissue. This hormonal treatment is being studied in the case of preventing fractures which may affects women sufferinf from with osteoporosis, as well. The study concerned with treating men suffering from prostate cancer with denosumab is in the third phase called Phase 3 trial and supports the application to Amgen`s Incorporated FDA approval.
More than 900 non-metastatic prostate cancer patients took part in the study. They were receiving an androgen-deprivation therapy. Patients were registered in 156 centers in Europe and United States and on a random basis they were programmed to receive injections with either the denosumab hormonal therapy or a placebo during three years, every six months. Prostate cancer patients also had to ingest a daily dose of calcium and vitamin D which fastens the calcium absorption in the body as supplements for the three year clinical trial. The research proved that denosumab increased the density of the bones of all the patients receiving this hormonal therapy in all the centers from Europe and North America. It was observed that denosumab increased the density of lumbar spine, total hip and femoral neck and decreased by 62 percent the fractures of the vertebral spine. Moreover, the density of the radius – a bone in the forearm, was also enhanced by this treatment. This is one improvement which never appeared in other studies regarding bisphosphonates or other drugs against osteoporosis. Secondary effects of denosumab treatment were recorded, but they were few in number and surpassed those of the bisphosphonates drugs which cause the osteonecrosis of the jaw bone. Denosumab did not cause this type of negative effect in patients.
Leader of the research team and associated professor in the Medicine department of Harvard Medical School stated about the study: “Denosumab is an important new therapy to prevent painful fractures in prostate cancer survivor. An ongoing clinical trial will also evaluate whether denosumab prevents spread of prostate cancer to bone, the most common site of metastases in men with this disease.”
