Building on prior observations, a meta-regression of published trials has concluded that larger improvements in bone mineral density (BMD) via dual‐energy X‐ray absorptiometry (DXA) are associated with greater reductions in fracture risk, particularly for vertebral and hip fractures. First author Mary Bouxsein, PhD, of the Center for Advanced Orthopedic Studies at Beth Israel Deaconess Medical Center and Harvard Medical School in Boston, and colleagues published their findings in the Journal of Bone and Mineral Research (JBMR).
“Although these results cannot be directly applied to predict the treatment benefit in an individual patient, they provide compelling evidence that improvements in BMD with osteoporosis therapies may be useful surrogate endpoints for fracture in trials of new therapeutic agents,” the authors wrote.
The investigators selected 38 placebo‐controlled studies involving 19 therapeutic agents to determine the connection between improvements in BMD and reductions in fracture risk. The studies evaluated six bisphosphonates (20 trials); four selective estrogen receptors modulators (SERMS) (5 trials); calcitonin/estrogen compounds (2 trials); tibolone (1 trial); an anti-Rank Ligand antibody (2 trials); parathyroid hormone (PTH) (1-84) (1 trial); two PTH analogs (4 trials), an anti-sclerostin antibody (1 trial) and a cathepsin K inhibitor (1 trial).
Individual trial sizes ranged from 246 to more than 16,000 participants, with 1 to 8 years of follow-up. Of the 38 studies, 32 were limited to postmenopausal women, whereas 5 trials enrolled both men and women and one trial men only.