Table 2.
Changes in study outcomes following 12 months of trandermal testosterone or placebo.
| Testosterone (n=53) | Placebo (n=46) | Betwn Grp Changes (n=99) | |||||
|---|---|---|---|---|---|---|---|
| Hormones | baseline | 12 mth | % change | baseline | 12 mth | % change | P value** |
| Total Testosterone ng/dL | 396.3 ± 162.8 | 583.6 ± 344.2 | 95.8* | 407.8 ± 206.5 | 477.7 ± 244.7 | 16.0* | 0.054 |
| Biotestosterone ng/dL | 62.6 ± 28.6 | 156.8 ±175.9 | 185.3* | 66.1 ± 32.4 | 79.1 ± 45.0 | 17.7* | 0.001 |
| Estradiol pg/mL | 33.8 ± 8.3 | 37.6 ± 12.5 | 14.5* | 31.0 ± 7.5 | 30.6 ± 7.2 | −0.18 | 0.025 |
| SHBG ug/dL | 1.45 ± 0.58 | 1.87 ± 1.11 | 31.7* | 1.48 ± 0.65 | 1.91 ± 0.83 | 42.5* | 0.33 |
| DHEA ug/dL | 64.4 ± 51.4 | 58.4 ± 50.4 | −9.6* | 46.2 ± 41.7 | 40.9 ± 31.4 | −1.5 | 0.12 |
| 25 Hydroxyvitamin D nmol/L | 91.5 ± 37.1 | 145.6 ± 50.9 | 73.0* | 86.1 ± 35.8 | 140.3 ± 51.6 | 79.3* | 0.64 |
| iPTH pg/mL | 61.5 ± 28.5 | 49.8 ± 21.8 | −15.9* | 69.4 ± 37.8 | 55.5 ± 24.2 | −14.2* | 0.75 |
| Bone Mineral Density | |||||||
| Total Femur BMD(g/cm2) | 0.894 ± 0.098 | 0.898 ± 0.102 | 0.41 | 0.876 ± 0.120 | 0.880 ± 0.123 | 0.45 | 0.95 |
| Total Femur tscore | −1.50 ± 0.75 | −1.48 ± 0.79 | −1.65 ± 0.93 | −1.62 ± 0.95 | |||
| Femoral Neck BMD (g/cm2) | 0.800 ± 0.090 | 0.811 ± 0.094 | 1.38* | 0.794 ± 0.103 | 0.797 ± 0.105 | 0.40 | 0.12 |
| Femoral Neck tscore | −2.08 ± 0.69 | −1.99 ± 0.72 | −2.12 ± 0.79 | −2.10 ± 0.81 | |||
| Trochanter BMD (g/cm2) | 0.803 ± 0.110 | 0.805 ± 0.115 | 0.27 | 0.786 ± 0.128 | 0.787 ± 0.132 | 0.16 | 0.91 |
| Trochanter tscore | −1.16 ±1.00 | −1.14 ±1.04 | −1.31 ± 1.16 | −1.30 ± 1.20 | |||
| Spine L1-L2 BMD (g/cm2) | 1.139 ± 0.202 | 1.176 ± 0.221 | 3.25* | 1.110 ± 0.170 | 1.108 ± 0.174 | 1.05 | 0.03 |
| Spine L1-L2 tscore | −0.51 ± 1.68 | −0.20 ± 1.85 | −0.85 ± 1.42 | −0.79 ± 1.45 | |||
| Spine L2-L4 BMD (g/cm2) | 1.250 ± 0.237 | 1.285 ± 0.238 | 3.07* | 1.202 ± 0.211 | 1.205 ± 0.216 | 0.20 | 0.005 |
| Spine L2-L4 tscore | 0.08 ± 1.98 | 0.38 ± 1.98 | −0.31 ± 1.76 | −0.31 ± 1.79 | |||
| Forearm Mid Radius BMD (g/cm2) | 0.726 ± 0.087 | 0.716 ± 0.087 | −1.29* | 0.714 ± 0.096 | 0.712 ± 0.91 | −0.20 | 0.008 |
| Forearm Mid Radius tscore | −0.96 ± 1.05 | −1.08 ± 1.01 | −1.11 ± 1.16 | −1.13 ± 1.10 | |||
| Whole Body BMD (g/cm2) | 1.161 ± 0.088 | 1.160 ± 0.087 | −0.04 | 1.155 ± 0.096 | 1.153 ± 0.092 | −0.13 | 0.76 |
| Whole Body tscore | −0.74 ± 1.09 | −0.75 ± 1.09 | −0.81 ± 1.20 | −0.84 ± 1.15 | |||
| Bone Turnover Markers | |||||||
| NTX/CR nMBCE/mM | 45.1 ± 56.8 | 35.9 ± 25.9 | −6.6 | 43.0 ± 30.5 | 37.1 ± 38.1 | −12.2 | 0.56 |
| DPD/CR nM/mM | 5.6 ± 2.2 | 5.2 ± 2.2 | −1.1 | 5.0 ± 1.8 | 5.4 ± 1.8 | 16.5 | 0.03 |
| BAP U/L | 27.3 ± 22.3 | 22.7 ± 7.0 | −13.6* | 25.8 ± 10.5 | 22.2 ± 7.0 | −11.4* | 0.56 |
| Osteocalcin ng/mL | 10.4 ± 5.2 | 8.1 ± 4.8 | −19.0* | 11.0 ± 6.5 | 8.5 ± 3.8 | −11.9* | 0.28 |
| P1NP ug/L | 53.3 ± 56.6 | 38.3 ± 19.4 | −15.2* | 46.7 ± 25.2 | 38.6 ± 21.4 | −12.6* | 0.67 |
| Body Composition | |||||||
| Total Body Fat % | 28.5 ± 7.0 | 26.8 ± 7.1 | −6.8* | 28.0 ± 7.6 | 27.2 ± 7.3 | −2.8* | 0.06 |
| Total Body Lean Kg | 53.0 ± 6.3 | 54.0 ± 6.8 | 1.9* | 52.6 ± 7.0 | 52.8 ± 7.6 | 0.3 | 0.027 |
| Appendicular Skeletal Mass | 22.6 ± 3.3 | 22.9 ± 3.4 | 1.3 | 22.3 ± 3.8 | 22.1 ± 4.0 | −1.0 | 0.016 |
| Strength | |||||||
| Handgrip Kg | 24.7 ± 8.2 | 25.2 ± 7.1 | 5.9 | 25.2 ± 8.4 | 26.3 ± 9.1 | 5.2 | 0.89 |
| Leg press Newtons | 716 ± 197 | 737 ± 246 | 3.6 | 645 ± 226 | 638 ± 226 | −0.0 | 0.38 |
| Leg press Power Watts | 263 ± 136 | 232 ± 121 | −5.6* | 256 ± 143 | 217 ± 122 | −10.6* | 0.43 |
| Physical Performance | |||||||
| PASE kilocalories | 941 ± 760 | 946 ± 884 | 49 | 772 ± 605 | 785 ± 720 | 109 | 0.46 |
| PASE score | 200 ± 125 | 206 ± 139 | 11 | 181 ± 134 | 199 ± 139 | 37 | 0.17 |
| SPPB score | 9.5 ± 2.1 | 8.6 ± 2.8 | −8.4* | 9.1 ± 2.3 | 8.3 ± 2.9 | −8.8* | 0.93 |
| 8 ft walk m/sec | 0.89 ± 0.21 | 0.86 ± 0.21 | −1.6 | 0.94 ± 0.23 | 0.88 ± 0.27 | −4.2* | 0.11 |
| Chair rise time sec | 15.3 ± 6.1 | 15.6 ± 4.9 | 8.2 | 15.1 ± 5.4 | 16.1 ± 8.3 | 10.5 | 0.79 |
| Single leg stance sec | 9.6 ± 9.0 | 8.3 ± 9.0 | 7.0 | 10.1 ± 9.7 | 7.8 ± 9.2 | −6.1* | 0.54 |
| Supine to Stand sec | 8.8 ± 7.0 | 7.7 ± 5.0 | 9.4 | 6.4 ± 5.7 | 6.3 ± 6.9 | −3.0 | 0.40 |
| Get up and go sec | 12.4 ± 5.3 | 12.0 ± 5.1 | 0.2 | 10.9 ± 4.1 | 12.3 ± 8.0 | 10.7 | 0.11 |
| Safety and Compliance | |||||||
| Total Cholesterol mg/dL | 184 ± 40 | 178 ± 36 | −1.7 | 195 ± 30 | 184 ± 33 | −4.7* | 0.37 |
| HDL mg/dL | 45 ± 12 | 45 ± 12 | 1.4 | 47 ± 14 | 46 ± 13 | −0.1 | 0.66 |
| LDL mg/dL | 118 ± 34 | 111 ± 32 | −2.2* | 124 ± 28 | 114 ± 30 | −5.5* | 0.57 |
| Triglycerides mg/dL | 115 ± 89 | 109 ± 94 | −13.1 | 115 ± 63 | 104 ± 52 | −28.4 | 0.59 |
| IPSS prostate symptom score | 7.5 ± 5.8 | 7.6 ± 5.9 | 23.6 | 8.8 ± 5.9 | 8.7 ±6.6 | 1.7 | 0.23 |
| IPSS quality of life | 2.7 ± 1.3 | 2.5 ± 1.3 | −2.0 | 3.1 ± 1.3 | 3.0 ± 1.5 | 1.8 | 0.65 |
| UCLA Prostate Index score r | 21.0 ± 7.3 | 20.5 ± 7.7 | 1.0 | 18.9 ± 6.9 | 19.2 ± 7.3 | 3.7 | 0.59 |
| PSA ug/L | 1.94 ± 1.36 | 1.89 ± 1.37 | 9.78 | 1.92 ± 1.16 | 1.90 ± 1.58 | 3.03 | 0.62 |
| Hematocrit % | 42.3 ± 3.9 | 42.8 ± 4.9 | 1.4 | 41.8 ± 4.3 | 41.6 ± 4.5 | −0.45 | 0.25 |
| Compliance % based on expected 5g/day | - | 56 ± 32 | - | 52 ± 32 | 0.51 | ||
| 70% compliant or higher | 40 (26) | 39 (23) | 0.86 | ||||
*
signifies statistical significance at p<.05 by paired t-test for within group change
**
signifies statistical significance at p <.05 by one-way analysis of variance to assess between group change
BMI –body mass index; SHBG –sex hormone binding globulin; DHEA –dehydroepiandrosterone; iPTH –intact parathyroid hormone; BMD- bone mineral density; NTX/CR –n-telopeptide/creatinine; DPD/CR –deoxypyridinoline/creatinine; BAP-bone specific alkaline phosphatase; P1NP –procollagen peptide of type I collagen; SPPB –short physical performance battery; HDL –high density lipoprotein; LDL –low density lipoprotein; CESD- Center for Epidemiologic Studies –Depression; IPSS –International Prostate Symptom Score; UCLA –University of California, Los Angeles; PSA –prostate specific antigen;