Session: SUN 199-233-Bone Biology
Poster Board SUN-212
Methods: This randomized, controlled crossover study was composed of two 3-month study periods each consisting of a 1-week inpatient and 3-month outpatient phase. 12 children/adolescents with hypoparathyroidism (7-20 yo; 5 males) with APS-1(n=5) or CaR (n=7) were studied. Each patient was randomly assigned to receive synthetic PTH 1-34 either by pump or twice-daily injection delivery during the initial treatment arm and crossed over to the opposite treatment arm at 3 months. At the end of each 3-month study period, serum and 24-h urine mineral levels and bone turnover markers were measured daily for 3 days during an inpatient evaluation. Serial (every 2 h) blood and urine (every 4 h) were obtained on the 4thday of each admission.
Results: PTH 1-34 delivered by an insulin pump resulted in simultaneous normalization of blood (Ca=2.02 mmol/L [N: 2.05-2.5]) and urine calcium (5.17 mmol/24h/1.73 m2body surface area; [N: 1.25-7.5]) levels and markers of bone turnover. Twice-daily injections produced lower mean serum Ca (1.88 mmol/L ; P<0.02 injections vs. pump) and higher mean urine calcium (6.67 mmol/24h). The mean daily PTH dose was 0.85 mcg/kg body weight for the injection arm and 0.32 mcg/kg for the pump arm(P<0.01, injections vs. pump). Markers of bone turnover were within the normal range during pump delivery, but were above the normal range, and significantly higher, during twice-daily injection delivery. Serial testing during twice-daily injections revealed a biphasic diurnal pattern for serum and urine calcium and magnesium, and for urine cyclic AMP excretion, compared to minimal fluctuation during pump delivery.
Conclusions: PTH replacement therapy is more physiologic when delivered by an insulin pump than by twice-daily injection. Pump delivery simultaneously normalized bone turnover markers and urine and serum mineral levels, whereas twice-daily injection delivery did not, either in this study or in previous studies of patients with congenital hypoparathyroidism due to CaR and APS-1. The improved metabolic control with pump delivery was achieved at a fraction of the daily PTH dose needed for twice-daily injection delivery.
Disclosure: GBC Jr.: , Eli Lilly & Company, , Eli Lilly & Company. Nothing to Disclose: KKW, KAF, PSA, DN
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