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Osteoporosis weakens bones and makes them more likely to break. The disease affects about 10 million Americans over age 50, including one in five women. And those numbers are expected to rise as the share of Americans 65 and older climbs from 18.9% to 23.4% by 2060.

Until now, clinical researchers have tested the effectiveness of drug treatments to strengthen patients' bones by tracking whether the patients suffered fractures. The approach can take years, making new drug development slow and expensive.

But a decision by the U.S. Food and Drug Administration (FDA) late last year changed that. The FDA will now allow researchers to use changes in hip bone density instead of fractures as the primary measure of success in certain late-stage clinical trials of new osteoporosis drugs. For now, the change applies to trials involving postmenopausal women with osteoporosis.

The change grew out of research co-led by UC San Francisco as part of the Study to Advance Bone Mineral Density as a Regulatory Endpoint (SABRE), a public-private collaboration involving academia, the National Institutes of Health (NIH), the FDA, industry and nonprofits.

We spoke with Dennis Black, Ph.D., a UCSF professor of epidemiology and biostatistics and co-lead of the SABRE Project, about what the change means for drug development and patients.

The most recent drug approval was for romosozumab in 2019. But since then, there have been no new drugs in the pipeline because of the expense and time needed to develop them.

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