Table 5.
Estimated changes from baseline in laboratory measures by treatment arm
| Variable | Placebo | 1 mg/day | 5 mg/day | 15 mg/day | P value (5 mg/day vs Placebo) | P value (any effect) |
|---|---|---|---|---|---|---|
| Laboratory hematology | ||||||
| White blood cell, K/uL | −0.22 (−0.54, 0.09) | 0.14 (−0.22, 0.50) | −0.23 (−0.52, 0.06) | 0.18 (−0.29, 0.65) | 0.98 | 0.19 |
| Red blood cell, K/uL | −0.07 (−0.14, −0.01) | −0.05 (−0.12, 0.03) | 0.02 (−0.04, 0.08) | −0.02 (−0.12, 0.09) | 0.038 | 0.20 |
| Hemoglobin, g/dL | −0.32 (−0.51, −0.12) | −0.05 (−0.28, 0.18) | 0.08 (−0.11, 0.27) | −0.20 (−0.50, 0.11) | 0.003 | 0.026 |
| Hematocrit, % | −0.58 (−1.19, 0.03) | 0.0004 (−0.71, 0.71) | 0.58 (−0.002, 1.16) | −0.29 (−1.23, 0.65) | 0.005 | 0.040 |
| MCV, fL | 0.41 (−0.24, 1.07) | 0.73 (−0.04, 1.50) | 0.84 (0.22, 1.46) | 0.02 (−0.98, 1.03) | 0.32 | 0.50 |
| RDW, % | 0.06 (−0.18, 0.29) | 0.10 (−0.17, 0.37) | 0.23 (0.01, 0.46) | −0.22 (−0.58, 0.13) | 0.25 | 0.18 |
| Platelet count, K/uL | −0.78 (−9.93, 8.36) | 0.62 (−10.02, 11.3) | 11.2 (2.52, 19.9) | 43.0 (29.0, 56.9) | 0.050 | <0.001 |
| Glucose homeostasis | ||||||
| Hemoglobin A1c, % | −0.06 (−0.14, 0.03) | −0.07 (−0.16, 0.03) | −0.04 (−0.11, 0.04) | −0.09 (−0.22, 0.03) | 0.70 | 0.87 |
| Glucose, mg/dL | 0.62 (−2.39, 3.63) | 1.65 (−1.81, 5.11) | −3.63 (−6.47, −0.80) | −7.54 (−12.1, −2.96) | 0.035 | 0.003 |
| Insulin, uIU/mL | 0.27 (−1.11, 1.65) | 0.67 (−0.99, 2.33) | −0.34 (−1.63, 0.95) | −0.37 (−2.41, 1.67) | 0.50 | 0.74 |
| HOMA-IR | 0.03 (−0.37, 0.44) | 0.18 (−0.31, 0.67) | −0.20 (−0.57, 0.18) | −0.22 (−0.82, 0.38) | 0.39 | 0.56 |
| Liver function tests | ||||||
| AST, U/L | −0.61 (−3.19, 1.98) | −0.49 (−3.50, 2.52) | 3.14 (0.64, 5.65) | 8.57 (4.51, 12.6) | 0.032 | <0.001 |
| ALT, U/L | −1.51 (−7.36, 4.34) | −2.03 (−8.92, 4.85) | 0.93 (−4.65, 6.50) | 17.6 (8.66, 26.6) | 0.53 | 0.003 |
| Total bilirubin, mg/dL | −0.13 (−0.17, −0.09) | −0.04 (−0.09, 0.01) | −0.14 (−0.18, −0.10) | −0.17 (−0.24, −0.11) | 0.84 | 0.003 |
| Lipid panel | ||||||
| Total cholesterol, mg/dL | −7.25 (−14.9, 0.41) | −14.9 (−23.8, −6.01) | −15.8 (−23.1, −8.42) | −13.3 (−25.1, −1.52) | 0.10 | 0.36 |
| HDL, mg/dL | −2.43 (−4.43, −0.43) | −5.48 (−7.82, −3.15) | −13.5 (−15.4, −11.6) | −18.4 (−21.5, −15.4) | <0.001 | <0.001 |
| LDL, mg/dL | −5.34 (−11.8, 1.13) | −6.70 (−14.2, 0.83) | −0.07 (−6.25, 6.12) | 7.44 (−2.51, 17.4) | 0.22 | 0.09 |
| Triglycerides, mg/dL | 1.97 (−11.0, 14.9) | −14.7 (−29.9, 0.53) | −15.0 (−27.4, −2.70) | −14.0 (−34.0, 6.01) | 0.050 | 0.18 |
| Bone markers | ||||||
| NTX, nM BCE | 0.60 (−0.53, 1.73) | −0.33 (−1.65, 0.99) | 0.54 (−0.51, 1.58) | 0.54 (−1.15, 2.24) | 0.93 | 0.67 |
| Osteocalcin, ng/mL | 0.10 (−0.64, 0.84) | −0.29 (−1.15, 0.57) | −0.08 (−0.77, 0.61) | 0.09 (−1.02, 1.20) | 0.72 | 0.90 |
| PINP, ug/L | 2.41 (−0.66, 5.49) | 1.89 (−1.68, 5.46) | 5.13 (2.31, 7.96) | 0.07 (−4.50, 4.63) | 0.18 | 0.20 |
| Alkaline phosphatase, U/L | −2.56 (−5.43, 0.30) | −3.38 (−6.54, −0.21) | −10.2 (−12.9, −7.61) | −16.9 (−21.1, −12.8) | <0.001 | <0.001 |
| Bone alkaline phosphatase, ng/mL | −0.44 (−0.99, 0.11) | −0.27 (−0.90, 0.36) | −0.46 (−0.95, 0.04) | −1.28 (−2.08, −0.48) | 0.96 | 0.23 |
| Testosterone | ||||||
| Total testosterone, ng/dL | −2.9 (−46.8, 41.0) | −91.2 (−140.4, −42.0) | −165.1 (−206.1, −124.0) | −178.4 (−241.6, −115.2) | <0.001 | <0.001 |
| Free testosterone, pg/mL | 1.9 (−2.1, 6.0) | 6.9 (2.3, 11.4) | 15.1 (11.3, 18.9) | 17.9 (12.2, 23.6) | <0.001 | <0.001 |
| SHBG, nmol/L | −2.4 (−6.1, 1.4) | −12.3 (−16.5, −8.2) | −22.7 (−26.1, −19.3) | −25.4 (−30.5, −20.3) | <0.001 | <0.001 |
| LH, mIU/mL | −0.19 (−2.10, 1.71) | −0.27 (−2.37, 1.84) | 0.39 (−1.41, 2.18) | −1.15 (−3.79, 1.49) | 0.60 | 0.78 |
| Estradiol, pg/mL | −0.9 (−3.7, 1.9) | −1.4 (−4.6, 1.7) | −5.2 (−7.8, −2.6) | −7.3 (−11.2, −3.4) | 0.012 | 0.008 |
The data are point estimates and 95% CIs extracted from mixed model framework. P values for overall and for prespecified comparison of 5-mg vs placebo.
Abbreviations: ALT, alanine transaminase; AST, aspartate transaminase; HDL, high-density lipoprotein; HOMA-IR, homeostatic model assessment of insulin resistance; LDL, low-density lipoprotein, LH, luteinizing hormone; MCV, mean corpuscular volume; RDW, red blood cell distribution width; NTx, N-telopeptide of collagen; PINP, procollagen I intact N-terminal; SHBG, sex hormone–binding globulin.