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.
OBJECTIVE
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.


METHODS
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.


METHODS
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).


METHODS
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).


CONCLUSIONS
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.
Department of Child Health, Royal Hospital for Sick Children, Yorkhill, Glasgow, UK. gc1328@clinmed.gla.ac.uk
S F
SF
Ahmed
P
P
Tucker
A
A
Mayo
A M
AM
Wallace
I A
IA
Hughes
D000284:Administration, Oral; D000293:Adolescent; D000469:Alkaline Phosphatase / Q000097:blood*; D000886:Anthropometry; D001846:Bone Development; D001842:Bone and Bones / Q000201:enzymology; D002648:Child; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D004343:Drug Implants; D006801:Humans; D008297:Male; D011446:Prospective Studies; D013739:Testosterone / Q000008:administration & dosage* / Q000031:analogs & derivatives*
D003692:Delayed-Action Preparations; D004343:Drug Implants; D013739:Testosterone; D000469:Alkaline Phosphatase; C010792:testosterone undecanoate