A policy shift on osteoporosis trials highlights a broader evidence question: bone mineral density is useful because it tracks fracture risk, but it is still a surrogate, not the outcome patients care about most. That distinction matters. A drug can improve scan results without necessarily delivering the same real-world benefit in fewer broken bones, so longer-term fracture data will still be important for confirming value and safety.
The upside is speed. If studies can read out sooner and at lower cost, more companies may test therapies for a condition that already has effective options but not enough innovation. For patients, that could mean more choices over time, including medicines that may better match different risk profiles. The trade-off is that faster development can also mean the evidence base starts narrower, with less certainty about who benefits most and how durable the effect is.
Osteoporosis care is not only about medication. The article’s example also shows why fall prevention remains part of the biology of fracture risk: balance, footwear, home hazards and confidence on icy surfaces all shape whether brittle bones actually break. Those measures do not replace treatment, but they can reduce the chance that a stumble becomes an injury.
There is also a reminder about underdiagnosis. Many people do not start treatment until after a fracture, even when risk has been building for years. That gap is often driven by missed screening, low awareness and concern about rare side effects. In practice, the challenge is not just finding new drugs, but helping people weigh benefits and harms early enough to prevent the first break.
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Maggie Holtzberg was walking recently when she started sliding on a sheet of ice. This time of year, many of us fear slipping on treacherous frozen sidewalks. But for Holtzberg, it’s a much bigger concern. The 70-year-old has osteoporosis, a condition that causes brittle bones that can easily fracture after a fall. About a decade ago, she broke a bone falling on the ice. “I thought, `I better not do this,’” she said. “I don’t want to do anything stupid.” But even as winter weather has osteoporosis patients on high alert, they just found new reason for hope. Last month, the Food and Drug Administration made an important policy change that’s expected to spark new interest in treating the common bone disease. Instead of waiting years to see whether clinical trial participants experience fewer fractures, drugmakers can now measure whether their medicine increases bone mineral density. This will make clinical trials much shorter and cheaper. And it’s expected to entice more biotech companies to pursue new drugs and investors to back them. Bouxsein led a team that showed how changes in bone mineral density are a good predictor of how well a drug will work, leading to the FDA’s recent decision. “I’m very confident this decision will spur discovery, innovation and investment in the osteoporosis field,” she says. There are a few drugs available that can slow the breakdown of bones that comes with aging. Some can even build bones back. But Bouxsein says there’s a lack of awareness about treatment options and some patients have concerns about the rare side effects that come with them. Kristina Burow, a managing director at the biotech investment firm Arch Venture Partners, says she’s eager to back companies developing new osteoporosis treatments, since “there are so few.” Burow says there needs to be more research on what causes the condition. She also says some people wrongly see osteoporosis as a niche condition. “If you’re a woman, if you live long enough, you will get osteoporosis,” she says. “That doesn’t seem niche to me.” // Holtzberg, who lives in Newton, Massachusetts, knew the condition ran in her family. Her mother and grandmother both had osteoporosis. But for a while, she didn’t take it seriously because she’s physically active and builds muscle quickly. During the pandemic, she stopped taking the recommended bone density tests that might have indicated the need for medication. Then about three years ago, she tripped in her house and broke a bone in her shoulder. Six months after that, she tripped again and broke a bone in her other shoulder. She finally got a diagnosis of severe osteoporosis and began taking Evenity, an osteoporosis drug made by Amgen. Her bone density has improved, she said. “It was a shock to have two breaks in a year,” she says. “That was a wake-up call.” — Gerry Smith |
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