Effects of oral testosterone undecanoate therapy on bone mineral density and body composition in 322 aging men with symptomatic testosterone deficiency: a 1-year, randomized, placebo-controlled, dose-ranging study

Figures & data

Figure 1. Flow chart of the disposition of patients.

Figure 2. Effect of oral TU on osteocalcin and type I collagen C-telopeptide (mean percent change from baseline in the intention to treat group).

Figure 3. Effect of oral TU on BMD at the lumbar spine (L₁–L₄) and total hip at Month 12 (mean percent change from baseline in the intention to treat group).

Table 1. Effects of oral TU and placebo on BMD (g/cm³) after 12 months of treatment (ITT-group, LOCF approach).

		Oral testosterone undecanoate
Bone mineral density at various sites	Placebo	80 mg/day	160 mg/day	240 mg/day
Lumbar spine L1-L4
Baseline	1.057 ± 0.171	1.040 ± 0.140	1.022 ± 0.170	1.031 ± 0.175
% CFB at Month 12	1.12 ± 3.16	0.81 ± 2.83	1.68 ± 3.35	2.70 ± 3.39*
Total hip
Baseline	0.996 ± 0.136	1.022 ± 0.133	1.003 ± 0.126	1.012 ± 0.107
% CFB at Month 12	−0.44 ± 2.58	0.00 ± 2.68	0.64 ± 3.56	0.84 ± 2.02*
Femoral neck
Baseline	0.809 ± 0.117	0.845 ± 0.136	0.819 ± 0.135	0.842 ± 0.124
% CFB at Month 12	0.48 ± 4.61	−0.03 ± 3.74	−0.09 ± 3.47	0.88 ± 3.49
Trochanter
Baseline	0.791 ± 0.115	0.813 ± 0.127	0.788 ± 0.114	0.812 ± 0.107
% CFB at Month 12	−0.33 ± 3.43	0.39 ± 2.81	1.37 ± 4.00**	1.21 ± 2.16*
Intertrochanter
Baseline	1.159 ± 0.168	1.185 ± 0.148	1.170 ± 0.162	1.174 ± 0.131
% CFB at Month 12	−0.92 ± 3.10	−0.08 ± 3.17	0.68 ± 3.83*	0.59 ± 2.66*
Ward’s triangle
Baseline	0.619 ± 0.120	0.628 ± 0.145	0.592 ± 0.148	0.622 ± 0.132
% CFB at Month 12	0.98 ± 8.41	2.42 ± 7.86	1.22 ± 10.06	1.63 ± 6.17

Data are shown as mean ± standard deviation.

%CFB = percentage change from baseline; ITT = intention to treat; LOCF = last observation carried forward; SD = standard deviation.

*p < 0.05, **p < 0.01 versus change in placebo.

Figure 4. Effect of oral TU on LBM and BFM (mean change from baseline in the intention to treat group).

Table 2. Effects of oral TU and placebo on body composition after 12 months of treatment (ITT group, LOCF approach).

		Oral testosterone undecanoate
Body composition	Placebo	80 mg/day	160 mg/day	240 mg/day
Total body mass (kg)
Baseline	84.6 ± 9.8	84.7 ± 12.8	86.8 ± 12.8	84.6 ± 13.6
CFB at Month 12	0.33 ± 3.37	0.30 ± 2.20	−0.16 ± 3.60	0.49 ± 3.15
LBM (kg)
Total	59.8 ± 6.2	59.5 ± 7.0	61.3 ± 7.8	60.0 ± 8.0
Baseline
CFB at Month 12	0.16 ± 1.38	0.83 ± 1.56*	1.20 ± 1.67***	1.72 ± 2.23***
Arms
Baseline	6.9 ± 0.9	6.9 ± 1.0	7.0 ± 1.1	7.0 ± 1.2
CFB at Month 12	0.16 ± 0.33	0.23 ± 0.32	0.32 ± 0.37	0.45 ± 0.49**
Legs	19.4 ± 2.2	18.9 ± 2.5	19.6 ± 2.8	19.3 ± 2.7
Baseline
CFB at Month 12	0.05 ± 0.62	0.30 ± 0.65*	0.37 ± 0.69**	0.56 ± 0.79***
Trunk
Baseline	29.9 ± 3.4	30.1 ± 4.0	31.0 ± 4.1	30.1 ± 4.3
CFB at Month 12	−0.06 ± 1.12	0.28 ± 1.11*	0.45 ± 1.11***	0.61 ± 1.43**
BFM (kg)
Total
Baseline	22.1 ± 5.7	22.5 ± 7.8	22.8 ± 6.5	21.8 ± 7.1
CFB at Month 12	0.15 ± 2.52	−0.53 ± 1.88	−1.36 ± 3.10**	−1.24 ± 2.62
Arms
Baseline	2.3 ± 0.7	2.4 ± 1.0	2.5 ± 0.8	2.3 ± 0.9
CFB at Month 12	0.13 ± 0.34	0.04 ± 0.36	−0.12 ± 0.42***	−0.12 ± 0.38***
Legs
Baseline	5.9 ± 1.6	6.0 ± 2.2	6.5 ± 1.9	5.8 ± 2.2
CFB at Month 12	0.03 ± 0.64	−0.18 ± 0.49	−0.59 ± 0.88***	−0.50 ± 0.73***
Trunk
Baseline	12.9 ± 3.8	13.2 ± 5.0	12.8 ± 4.3	12.7 ± 4.5
CFB at Month 12	−0.02 ± 1.74	−0.41 ± 1.34	−0.65 ± 1.97	−0.63 ± 1.84
Waist circumference (cm)
Baseline	100.0 ± 8.3	99.9 ± 10.3	101.5 ± 9.4	99.9 ± 10.6
CFB at Month 12	−0.33 ± 4.36	−0.59 ± 3.66	−1.19 ± 4.65	−0.82 ± 4.20

Data are shown as mean ± standard deviation.

ITT = intention to treat; LOCF = last observation carried forward; CFB = change from baseline.

*p < 0.05, **p < 0.01, ***p < 0.001 versus change in placebo.