Table 2.

Phase III clinical trials of denosumab for the treatment of postmenopausal osteoporosis or osteopenia58

Study	Aim	Control group	Mean age at baseline (years)	Mean lumbar spine T-score at baseline	Primary endpoint	Sample size (subjects)	Study period (years)	Efficacy	Safety: adverse events and serious adverse events
FREEDOM	Treatment of PMO	Placebo	72.3	−2.8	New vertebral fractures at 36 months	7868	3	↓ vertebral fracture risk	>cellulitis and eczema
DEFEND	Prevention of PMO	Placebo	59.4	−1.6	Lumbar spine BMD at 24 months	332	2	↑ BMD	>infections
DECIDE	Comparison of denosumab and alendronate	Alendronate	64.4	−2.6	Total hip BMD at 12 months	1189	1	> ↑ BMD	–
STAND	Switch from alendronate to denosumab	Continuing alendronate	67.6	−2.6	Total hip BMD at 12 months	504	1	↑ BMD with switch to denosumab	–

Note:>: more in the denosumab group than in the other group. Data from Hsu H, Lacey DL, Dunstan CR, et al. Tumor necrosis factor receptor family member RANK mediates osteoclast differentiation and activation induced by osteoprotegerin ligand. Proc Natl Acad Sci U S A. 1999;96(7):3540–3545.

Abbreviations: BMD, bone mineral density; PMO, postmenopausal osteoporosis.