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# Osteoporosis Drug Evaluation Guidance
- URL: https://www.fdaweb.com/osteoporosis-drug-evaluation-guidance/
- Published: 2019-08-15T12:00:00.000Z
- Updated: 2026-09-15T01:44:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144774

FDA has issued a guidance, *Osteoporosis:* *Nonclinical Evaluation of Drugs Intended for Treatment*, with recommendations for industry use in designing nonclinical bone quality studies to support approval of drugs and biologics intended to treat osteoporosis. The [document](https://www.fda.gov/media/129899/download?ref=fdaweb.com) recommends that sponsors review three agency guidances before starting clinical trials of drugs intended to treat osteoporosis.

Long-term nonclinical studies to evaluate bone tissue are warranted, FDA says, due to concerns about long-term adverse effects of drugs on bone quality and because there are no validated and reliable methods for the noninvasive assessment of bone quality in humans.

“Bone quality refers to those structural and material properties of bone that determine its biomechanical behavior in ways that are not accounted for by bone quantity or mass,” the guidance says. “An adverse effect on bone quality can be identified by an unfavorable change in the correlation between bone mass … and bone strength. The nonclinical bone quality studies are intended to evaluate this correlation and can provide support for the validity of bone mineral density as a surrogate marker for fracture risk in clinical studies. However, increases in bone mineral density and reductions in the incidences of bone fractures must still be established in clinical trials.”