The Egyptian Society for Osteoporosis and Geriatrics (ESOG) and global biotechnology pioneer AMGEN, announced that the Egyptian Ministry of Health has granted marketing authorization for Prolia (denosumab) for postmenopausal women at increased risk of fractures. Prolia is already approved in the EU, the US and several MEA countries.
“The Egyptian approval of Prolia is a significant medical advancement for patients with bone loss conditions i.e. osteoporosis said Dr Samir El Badawy, Professor of Rheumatology, Cairo University and ESOG President, “in particular, Prolia will offer patients with osteoporosis at increased risk of fracture an important alternative to current treatments. Prolia reduces the risk of fracture through a convenient injection given every six months and improves patient compliance. It is also quiet safe in the geriatric population with impaired kidney functions which is unique for Prolia.”
“Osteoporosis is a global health priority with population growth and ageing exacerbating the problem. Worldwide, osteoporosis is the number 1 bone disease, with 1 in 2 women and 1 in 5 men at risk of an osteoporotic fracture and a fracture occurring every 3 seconds,” said Dr Hassan Bassiouni, Professor of Rheumatology, Al Azhar University.
He revealed that osteoporosis affects 25 – 30% of the Egyptian population; studies have shown that nearly 54% of postmenopausal women in Egypt have osteopenia (the condition preceding osteoporosis) while 28.4% have osteoporosis and around 26% of men have ostopenia with 21.9% suffering from osteoporosis.
“The disease is often called the ‘silent thief’, because it is usually painless and has no symptoms until a fracture has occurred,” said Dr Adel Mahmoud, Professor of Rheumatology Ain Shams University. “There are many reasons that cause osteoporosis, some factors, such as age or gender, cannot be changed, but lifestyle choices, such as smoking, alcohol intake and diet can be modified.”
He offered some good news to those at risk: “There are many steps that can be taken to prevent and diagnose osteoporosis, which is nowadays a largely treatable condition, and with a combination of lifestyle changes and appropriate medical treatment, many fractures can be avoided.”
Dr Ashraf El Nahhal, Professor of Orthopedics, Cairo University said, “As bone surgeons our first meeting with osteoporosis patients occurs after a fracture, which is a very late stage of osteoporosis. It is a significant problem faced by the elderly in particular, with detrimental impact on their quality of life and that of their families.”
He emphasized that early detection of osteoporosis is the best means to prevent fractures. “Patients at risk should take a bone density test to determine whether they have the disease and if so, at what stage.”
“There are two categories of osteoporosis medications; antiresorptive medications slow down bone loss and anabolic ones that increase the rate of bone formation,” said Dr Timour El Husseini, Professor of Orthopedics, Ain Shams University. “The decision to take one drug over another is based on preference, convenience, adherence to the dosing schedule and cost.”
He explained how postmenopausal osteoporosis affects the bones. “The ongoing process of certain cells removing old bone while others rebuild it keeps bones strong. After menopause, bone removing cells cause bone loss at an overly rapid pace, leaving women with thinner and weaker bones and putting them at risk of fracture. Prolia (denosumab) helps stop the development of bone-removing cells before they can reach the bones and cause damage.”
Dr El Badawy showcased results from the pivotal three-year Phase 3 Fracture Reduction Evaluation of Denosumab in Osteoporosis every 6 months (FREEDOM) study on 7,808 women with postmenopausal osteoporosis. “Women receiving a subcutaneous injection of Prolia every 6 months experienced a 68% reduction in the relative risk of suffering a new vertebral (spine) fracture compared to those receiving a placebo. Additionally there was a 40% reduction in the relative risk of suffering a hip fracture and a 20% reduction in the relative risk of suffering a non-vertebral fracture at 36 months.
Ms Abeer Al Darouti, Executive Director of ESOG announced the launch of the Society’s awareness campaign “You are Stronger”. “Currently taking place across several social and sports clubs, the campaign aims to reach women over the age of 45 and raise their awareness of osteoporosis as well as how to avoid it and the best treatment options. We are also giving out free tests for measuring bone density so that patients can find out whether they have the disease.”