Key Takeaways
- In the Phase 3 ACTIVE trial, the bone-building drug abaloparatide cut new spinal fractures by 86 percent and nonvertebral fractures by 43 percent over 18 months compared with a placebo.
- The trial enrolled 2,463 postmenopausal women with osteoporosis and was published in the Journal of the American Medical Association in August 2016.
- Those results led the FDA to approve the drug, sold as Tymlos, on April 28, 2017, the first new bone-building agent for these patients in the United States in nearly 15 years.
Abaloparatide, a bone-building drug sold as Tymlos, cut the risk of new spinal fractures by 86 percent over 18 months in the Phase 3 ACTIVE trial of 2,463 postmenopausal women with osteoporosis, results published in the Journal of the American Medical Association in August 2016 that led the FDA to approve it in April 2017.
What the ACTIVE trial measured and found
The ACTIVE trial, short for Abaloparatide Comparator Trial In Vertebral Endpoints, was a randomized, double-blind, placebo-controlled study of 2,463 postmenopausal women with osteoporosis run over 18 months. Women given a daily injection of abaloparatide had 86 percent fewer new spinal fractures and 43 percent fewer nonvertebral fractures than women given a placebo. Spine bone mineral density rose about 11 percent over the same 18 months.
Those percentages describe relative reductions. In absolute terms, the Bone Health and Osteoporosis Foundation reported that the trial lowered new spinal fractures by 3.6 percentage points and nonvertebral fractures by 2.0 percentage points. Both ways of counting come from the same study. The results were published in JAMA in August 2016, and the FDA approved abaloparatide as Tymlos on April 28, 2017. It was the first new anabolic, or bone-building, agent for postmenopausal women with osteoporosis in the United States in nearly 15 years.
Why an 86% cut in spinal fractures matters for osteoporosis
Osteoporosis is common and quiet. It often shows no symptoms until a bone breaks. The Bone Health and Osteoporosis Foundation estimates that two million osteoporotic fractures occur each year in the United States, a number projected to reach three million by 2025, and that eight million women already have the disease while about 44 million more have low bone mass that raises their risk.
Most osteoporosis drugs slow bone loss. Abaloparatide instead signals the body to build new bone, which is why doctors call it anabolic. Robert Ward, the president and chief executive of Radius Health, the company that developed the drug, said "an osteoporotic fracture can be a life-altering event for a woman and her family." John Bilezikian, a professor of medicine at Columbia University, said the approval mattered because early fractures predict later ones. "Fragility fractures should be viewed as sentinel events which require urgent evaluation and treatment," Bilezikian said. The size of the fracture reduction is what draws attention to a drug like this, because each avoided fracture is an avoided hospital stay or lasting disability for an older adult.
People Also Ask
What is abaloparatide?
Abaloparatide is a bone-building drug for osteoporosis, sold under the brand name Tymlos. It is given as a daily injection and signals the body to build new bone, rather than only slowing bone loss. The FDA approved it on April 28, 2017 for postmenopausal women at high risk of fracture.
How well does abaloparatide prevent fractures?
In the ACTIVE trial, abaloparatide cut new spinal fractures by 86 percent and nonvertebral fractures by 43 percent over 18 months compared with a placebo. In absolute terms those were reductions of 3.6 and 2.0 percentage points across the 2,463 women in the study.
Can abaloparatide make adults taller?
The viral claim that it could make adults taller is not what the trial tested. The ACTIVE trial measured bone mineral density and the risk of fractures, not height or bone lengthening, and abaloparatide is approved to reduce fracture risk in postmenopausal women with osteoporosis.
How many people have osteoporosis?
The Bone Health and Osteoporosis Foundation estimates that eight million women in the United States already have osteoporosis and that about 44 million more have low bone mass that raises their risk. It counts about two million osteoporotic fractures a year, projected to reach three million by 2025.
Sources: Endocrine and Diabetes Plus, Bone Health and Osteoporosis Foundation.