Often referred to as a “silent disease,” osteoporosis affects approximately 9 million Americans. A further 43 million Americans suffer from low-bone density. Often, people with the disease may not know they have it until they suffer a bone break or fracture.
A disease so ubiquitous comes with a hefty price tag. According to the National Osteoporosis Foundation, bone breaks related to the disease cost around $19 billion annually. By 2025, that amount could increase to $25.3 billion.
The disease poses a substantial threat to postmenopausal women, as the lack of estrogen, a bone-protecting hormone, has a direct relationship with osteoporosis. A woman’s risk of hip fracture from osteoporosis, according to the National Osteoporosis Foundation, is on par with the combined risk of breast, uterine, and ovarian cancer.
“The disability after fracture can be incredible and not just hip (fracture),” said Dr. Lorraine Fitzpatrick, the chief medical officer of biopharmaceutical company Radius Health Inc., to R&D Magazine. “I’ve had ladies who use a walker and then they fall and break both wrists.”
“Can you imagine how disabling that is?”
Recently, Fitzpatrick and Radius Health presented the results of Phase 3 ACTIVE trials for their investigational drug abaloparatide-SC, an injectable synthetic peptide analog of human parathyroid hormone-related protein, which is critical to the formation of the skeleton. The presentation was given at Endocrine Society 2016 Annual Meeting in Boston.
Abaloparatide showed consistent protection against bone fractures, and increased bone mineral density in a broad group of postmenopausal women with osteoporosis, Fitzpatrick said.
The trial consisted of more than 2,400 postmenopausal women between the ages of 49- and 86-years-old. The patients were either treated with a placebo, abaloparatide, or teriparatide. The latter is currently approved to combat the silent disease.
Over the 18-month trial period, abaloparatide decreased new vertebral fractures by 86 percent, compared to teriparatide’s 80 percent; and reduced non-vertebral fractures by 43 percent, whereas teriparatide performed on par with the placebo.
Additionally, patients who took abaloparatide in the study showed greater increases in bone mineral density at the total hip and femoral neck sites.
Radius Health submitted a New Drug Application to the U.S. Food and Drug Administration on March 30, and the drug is currently undergoing regulatory review by the European Medicines Agency.
Like any drug, abaloparatide does have side effects, including hypercalcemia, dizziness, and palpitations. Both palpitations and hypercalcemia are known side effects of teriparatide. Although, “our amount of hypercalcemia was half of that of teriparatide,” Fitzpatrick added.
“If we can catch this earlier in the course of the disease and treat (patients), we’ll make their lives much more rewarding in their older years,” Fitzpatrick concluded.
Radius Health is in early development of a patch version of the drug.
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