Dr Bess Dawson-Hughes is a professor at Tufts University School of Medicine, United States, head of the Bone Metabolism Laboratory at the USDA Human Nutrition Research Center on Aging, and general secretary of the International Osteoporosis Foundation.
If you were to name the 3 most important recent advances in the management of osteoporosis, what would they be?
Bess Dawson-Hughes, MD: It is easy to be confused or disheartened with the findings of the recent mega trials testing vitamin D versus placebo to see whether it reduces fractures or falls. The evidence has been: no, they have shown no benefit. We attribute that to the fact that they recruited people who were already adequate in their vitamin D levels, so this in no way reduces the importance of vitamin D supplementation in elders and others in the population who have inadequate vitamin D status.
The early trials in which vitamin D was shown rather consistently to reduce the risk of fracture were conducted not only in insufficient elders, but also those trials included the combination of calcium and vitamin D supplementation. The landmark early study on this was the Chapuy et al trial (doi: 10.1056/NEJM199212033272305), which used 800 units of vitamin D and 1200 mg of calcium and saw very striking risk reductions for hip fracture and for other fractures. That has been confirmed in other trials and in a recent meta-analysis. [In] insufficient people treated with calcium and vitamin D, [the supplementation was] very important to reduce the risk of fracture.
The third point is: in your patients who are eligible for and being treated with pharmacotherapy for osteoporosis, calcium and vitamin D are essential accompaniaments of that treatment. The phase 3 trials in which pharmacotherapies were validated and got their Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals were done in patients who were supplemented with calcium and vitamin D—that would be in the treatment arm as well as in the placebo arm. Therefore, we have no assurance that the risk reduction for fracture that the pharmacotherapy wonderfully provides… We have no indication that it would be the same in calcium- and vitamin D–deficient patients, since the efficacy was established in the setting of adequate calcium and vitamin D [levels]. Thank you very much.