Table 1.
Studies of denosumab in postmenopausal women with low bone mass
| Study | Duration | Extent of bone disease | Total study size (plc) [60 mg/6 months] | Results | |
|---|---|---|---|---|---|
|
| |||||
| Fractures | % BMD [% change versus plc] | ||||
| McClung et al32 | 12 months | Osteopenia or osteoporosis (T-score < −1.8) | 412 (46) [47] | No difference in the sum of denosumab groups compared with plc (3.8% versus 2.2%)* | LS: 4.6 [5.4] Hip: 3.6 [4.2] |
| Lewiecki et al84 (one-year extension of study by McClung et al) | 24 months | Osteopenia or osteoporosis (T-score < −1.8) | 412 (46) [47] | Increased clinical (6.7% versus 2.2%) and osteoporotic (3.8% versus 0.0%) fractures in the sum of denosumab groups compared with plc* | LS: 7.4 [8.6] Hip: 5.1 [NR] |
| Miller et al85 (2-year extension of study by Lewiecki et al) | 48 months | Osteopenia or osteoporosis (T-score < −1.8) | 412 (46) [231] | No difference in clinical (10.5% versus 10.9%) and osteoporotic (7.0% versus 8.7%) fractures compared with plc* | LS: 9.4–11.8 [11.8–14.2] Hip: 4.0–6.1 [7.5–9.6] Distal radius: 1.0–1.7 [5.7–6.4] |
| Miller et al14 (2-year extension of study by Miller et al in 2008) | 72 months | Osteopenia or osteoporosis (T-score < −1.8) | 124 [124] | 4.5% (no plc group for comparison)* | LS: 13.3 Hip: 6.1 Distal radius: 1.9 |
| Bone et al33 | 24 months | Osteopenia or osteoporosis | 332 (166) [166] | Decreased vertebral (0% versus 0.6%) and nonvertebral (1% versus 4%) fractures compared with plc * | LS: 6.5 [7.1] Hip: 3.4 [4.5] Distal radius: 1.4 [3.5] |
| Cummings et al31 (FREEDOM trial) | 36 months | Osteoporosis (T-score ≤ −2.5) | 7868 (3906) [3902] | New vertebral fractures: 2.3% versus 7.2% in the plc group (68% reduction, P < 0.0001) [at 12 months 61%, at 24 months 78% reduction] New nonvertebral fractures: 6.5% versus 8.0% in the plc group (20% reduction, P < 0.011) Hip fractures: 0.7% versus 1.2% in the plc group (40% reduction, P < 0.036) |
LS: NR [9.2 (8.2–10.1)] Hip: NR [6.0 (5.2–6.7)] |
| Papapoulos et al30 (2-year extension of FREEDOM trial) | 60 months | Osteoporosis (T-score ≤ −2.5) | 2343 [2343] | New vertebral fractures: year incidence 1.4% versus 2.2% in the virtual plc New nonvertebral fractures: year incidence 1.1% versus 2.6% in the virtual plc |
LS: 13.7 Hip: 7.0 Distal radius: 2.3 |
| Brown et al13 | 12 months | Low bone mass (T-score ≤ −2) | 1189 (594) [595] | No difference in overall (4.0% versus 3.2%, P = 0.54) and osteoporotic (3.0% versus 2.2%, P = 0.37) fractures compared with alendronate* | LS: 5.3 Hip: 3.5 Distal radius: 3.1 |
Note:
*
Fractures reported as adverse events (not as endpoints of the study).
Abbreviations: plc, placebo; NR, not reported; BMD, bone mineral density (measured by dual energy x-ray absorptiometry); LS, lumbar spine; hip, total hip.