Twice-yearly leuprolide slows bone maturation in central precocious puberty
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A subcutaneous injection of leuprolide acetate every 6 months was effective and well tolerated in treating central precocious puberty in children, according to trial data.
As Healio previously reported, 87% of children receiving 45 mg of subcutaneous leuprolide acetate (Fensolvi, Tolmar Pharmaceuticals) at 6-month intervals had a serum luteinizing hormone level of less than 4 IU/L after 24 weeks. New findings presented at the AACE Annual Scientific and Clinical Conference revealed leuprolide acetate also suppressed the rate of bone maturation and increased predicted adult height in trial participants.
“A 6-month subcutaneous leuprolide acetate effectively treats central precocious puberty in children with about two injections or so per year,” Matthew R. Benson, MD, FAAP, a pediatric endocrinologist and assistant professor of pediatrics at the Mayo Clinic College of Medicine and Science, division of endocrinology diabetes and metabolism at Nemours Children’s Health System in Florida, told Healio. “Less injections, with the ease of subcutaneous administration.”
Researchers recruited 62 children (mean age, 7.5 years; 96.8% girls) with central precocious puberty to receive two doses of 45 mg subcutaneous leuprolide acetate at 24-week intervals. The first injection took place at baseline and the second at 24 weeks. Bone age advancement, weight, BMI and growth rate were measured in participants before treatment, at 24 weeks and at 48 weeks. Radiographs of the left hand and wrist were used to measure bone age advancement at baseline, 24 weeks and 48 weeks using the Greulich and Pyle method. Bone age advancement rate was calculated by the ratio of bone advancement to chronologic age. Predicted adult height was calculated at baseline and 48 weeks.
The study population had a slowdown in mean growth rate to 6.9 cm per year from baseline to week 24 and 5.8 cm per year from week 24 to week 48. Predicted adult height increased from 157 cm at baseline to 160 cm at week 48 (P < .001). The study cohort’s bone advancement to chronologic age ratio declined slightly from 1.4 at baseline to 1.3 at week 24 and remained similar from week 24 to week 48.
The study cohort had an increase in weight from 34.8 kg at baseline to 37.7 kg at week 24 and 40.4 kg at week 48. BMI increased slightly during the study from a mean of 18.56 kg/m2 at baseline to 19.71 kg/m2 at week 48.
Benson said more research is needed to compare the pharmacokinetics of subcutaneous leuprolide acetate with intramuscular forms of the drug.
“We think this drug may suppress puberty longer if delayed or late injections occur, keeping children with more effectively suppressed sex steroids if there are missed or delayed injections, which has been a problem in the last year during the COVID-19 pandemic,” Benson said. “There have been shortages of these products in the last year and that has been a challenge.”
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Benson MR. 6-Month Subcutaneous leuprolide acetate effectively suppressed rate of bone maturation and increased predicted adult height without significant increase in BMI in children with central precocious puberty. Presented at: American Association of Clinical Endocrinology Annual Scientific and Clinical Conference; May 26-29, 2021 (virtual meeting).
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