Randomized, Crossover Comparison Study of the Short-term Effect of Oral Testosterone Undecanoate and Intramuscular Testosterone Depot on Linear Growth and Serum Bone Alkaline Phosphatase

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AIM: To compare the effects of oral testosterone undecanoate (TU) 40 mg daily and intramuscular depot sustanon 50 (SUS), 4 weekly, on short-term growth and bone turnover. METHOD: Prospective, randomised, cross-over study over 26 weeks with 4 weeks of run-in, 8 weeks of treatment I (TU/SUS), 4 weeks of wash-out, 8 weeks of treatment II (SUS/TU) and 4 weeks of final wash-out. MAIN OUTCOME MEASURES: Weekly change in lower leg length (LLL) as measured by knemometry, i.e. LLL velocity (LLLV) and absolute bone alkaline phosphatase levels (bALP), as well as percentage change in bALP (%bALP). PATIENTS: Fourteen boys with delayed growth and puberty; two declined and one boy with sickle cell trait dropped out with priapism a week after SUS. The remainder had a median age of 14.3 years (range 12.5-17.4), testicular volume of 2 ml each (2-6), HtSDS of -2.1 (-3.3 to -1.0) and BA delay of 2.4 years (0.7-4.4). RESULTS: Median LLLV in the treatment blocks was 0.7 mm/wk (-0.27 to 2.2) and LLLV during the run-in and wash-out periods was 0.27 mm/wk (-0.3 to 0.6) (p <0.005). LLLV during treatment with TU and SUS was 0.51 mm/wk (-0.22 to 2.17) and 0.67 mm/wk (-0.27 to 2.2), respectively (NS). Median LLLV during the washout phases that followed the TU block and the SUS block was similar at 0.28 mm/wk (-0.1 to 0.6) and 0.3 mm/wk (-0.2 to 0.6), respectively. LLLV peaks and troughs that were related to the timing of the injection were more evident during SUS therapy. Median bALP during the run-in period was 94.2 U/l (16-282) and the median %bALP during this period was 1.2% (-57, 16). The main rise in bALP occurred during the treatment blocks with a %bALP of 19.3% (-28.8, 121.7) (p <0.005). Median bALP at the beginning and end of the SUS block was 99.7 U/l (51.7, 225) and 170 U/l (64.8, 273), respectively (p <0.05). Median bALP at the beginning and end of the TU block was 111 U/l (51, 287) and 127.6 U/l (66.4, 298) (NS). Median %bALP during SUS was higher than during TU at 28.1% (4.4, 121.7) and 11.8% (-28.8, 83.6) (p = 0.07). CONCLUSION: At the doses studied, testosterone undecanoate was as effective as sustanon at promoting short-term growth but changes in bone alkaline phosphatase were more marked during sustanon therapy.