Table 2.
Changes in Measures of Skeletal Muscle Mass and Fat Mass by Dual-Energy x-Ray Absorptiometer
| Body Composition Measurement (kg) | Testosterone, Mean ± SD |
Placebo, Mean ± SD |
Treatment Difference, Midtreatment |
Treatment Difference, Posttreatment |
||||||
| Baseline | Midtreatment | Posttreatment | Baseline | Midtreatment | Posttreatment | Mean(CI) | p | Mean(CI) | p | |
| ITT sample | (N = 82) | (N = 73) | (N = 77) | (N = 81) | (N = 75) | (N = 80) | ||||
| Total lean mass | 55.1 ± 6.9 | 57.2 ± 7.1 | 56.1 ± 6.9 | 56.5 ± 6.5 | 56.7 ± 6.2 | 56.2 ± 6.3 | 1.8 (1.2, 2.5) | .2 | 1.5 (0.4, 2.2) | <.0001 |
| Total fat mass | 26.2 ± 7.5 | 24.9 ± 7.1 | 24.0 ± 6.8 | 28 ± 8.4 | 28 ± 8.1 | 27.5 ± 7.9 | −1.7 (−2.7, −0.6) | .002 | −2.0 (−2.8, −1.2) | <.0001 |
| ASMM | 23.7 ± 3.3 | 24.7 ± 3.3 | 24.2 ± 3.3 | 24.1 ± 3 | 24.1 ± 3 | 23.9 ± 3.1 | 1.1 (0.7, 1.5) | <.0001 | 0.9 (0.4, 1.4) | .0009 |
| Appendicular fat mass | 9.7 ± 2.8 | 9.3 ± 2.8 | 8.9 ± 2.6 | 10.7 ± 3.5 | 10.6 ± 3 | 10.5 ± 3 | −0.3 (−0.6, −0.01) | .04 | −0.8 (−1.2, −0.4) | .0003 |
| Completion sample | (N = 69) | (N = 62) | (N = 69) | (N = 67) | (N = 63) | (N = 68) | ||||
| Total lean mass | 54.5 ± 7 | 56.7 ± 7.2 | 55.7 ± 7.1 | 57 ± 6.8 | 57.1 ± 6.5 | 56.5 ± 6.6 | 2.0 (1.3, 2.8) | <.0001 | 1.6 (0.8, 2.4) | <.0001 |
| Total fat mass | 25.6 ± 7.4 | 24.1 ± 6.9 | 23.5 ± 6.6 | 28.5 ± 8.6 | 28.7 ± 8.1 | 28.1 ± 8 | −1.9 (−3.1, −0.6) | <.0001 | −2.2 (−1.4, −3.1) | <.0001 |
| ASMM | 23.4 ± 3.4 | 24.5 ± 3.4 | 24.2 ± 3.4 | 24.3 ± 3.2 | 24.3 ± 3.1 | 24 ± 3.3 | 1.2 (0.8, 1.6) | <.0001 | 1.0 (0.4,1.5) | .0004 |
| Appendicular fat mass | 9.5 ± 2.9 | 9.1 ± 2.8 | 8.7 ± 2.6 | 10.9 ± 3.6 | 10.8 ± 3.1 | 10.7 ± 3 | −0.4 (−0.7,− 0.04) | .02 | −0.8 (−1.2, −0.4) | .0003 |
Notes: ASMM = appendicular skeletal muscle mass; CI = confidence interval; ITT = intention to treat.