With the Food and Drug Administration approval of Prolia at the beginning of June, new hope is available for postmenopausal women with osteoporosis (PMO) at high risk for fracture.
“This is a homegrown product,” noted Sarah Reins, spokesperson for Amgen, a leading human therapeutics company in the biotechnology industry, based in Thousand Oaks, California. “Our scientists discovered a pathway through which the drug works. This was a 15-year discovery process. The drug works by binding the protein, RANK ligand, that regulates cells called osteoclasts. Osteoclasts are the cells that break down the bone. In short, Prolia blocks the production of such cells.”
With a simple, twice-yearly injection under the skin, it’s a convenient way for those women with PMO to have another option available to them. Studies have shown that one in two women over the age of 50 will experience a fracture in their remaining lifetime.
According to the Amgen website (www.amgen.com) in their clinical trials, a three-year study among 7,808 women with PMO demonstrated that Prolia, administered as a 60mg injection just under the skin twice a year, compared with a placebo at three years, resulted in the following:
*A 68 percent reduction in vertebral fractures
*A 40 percent reduction in hip fractures
*A 20 percent reduction in non-vertebral fractures
*Significant bone density increases at all key sites measured
As with any drug or medication, there can be certain side effects in addition to the benefits. It is noted that patients with pre-existing hypocalcemia (a low level of calcium in the blood) have this condition corrected before initiating the Prolia injections. Hypocalcemia may worsen with Prolia, especially in patients who have severe renal impairment. It is advised that all patients be supplemented with calcium and vitamin D.
In addition to hypocalcemia, skin infections, as well as infections of the abdomen, urinary tract, and ear, may occur with the use of Prolia. Endocarditis, an infection of the heart’s valves or inner lining, was also reported more frequently in the Prolia-treated group. Other skin conditions, such as dermatitis, rashes, and eczema have been reported, as well. If severe symptoms do occur, the patient should consider discontinuing the use of Prolia.
The study also showed that the use of Prolia could result in suppression of bone remodeling, which can contribute to such outcomes as osteonecrosis of the jaw (ONJ). ONJ causes a destruction of the bone tissue due to lack of blood supply to the bone.
The most common adverse reactions, according to the study, were back pain, pain in extremities, musculoskeletal pain, cystitis, and hypercholesterolemia. Pancreatitis has also been reported with the use of Prolia.
However, it is exciting to recognize this new drug for PMO patients who might not respond well to other therapies. The possibility of improving one’s quality of life is always a good thing.