A double-blind, randomized, Phase III, multicenter study in 358 pediatric subjects receiving isotretinoin therapy demonstrates no effect on pediatric bone mineral density

Abstract

There is no difference in the effect of two formulations of isotretinoin on spine bone density after 6 months of treatment. BMD increased and the small change in spine Z-score over treatment disappeared after height adjustment. Mean positive Z-scores and HAZ in the study were likely due to the exclusion of low and inclusion of high Z-score subjects.

Perspective and Consensus Opinion: Good Practices for Using Organotypic Skin and Epidermal Equivalents in Experimental Dermatology Research

“…While high-dose retinoid exposure in animal studies have identified changes in bone mineral density, human clinical studies have observed variable results in different populations, with different retinoid drugs, and measurement techniques. Decreased bone mineral density associated with systemic retinoid treatment has been reported in some studies and not in others 87,88. The most relevant clinically important endpoint of decreased bone mineral density…”

The safety of isotretinoin treatment in patients with bone fractures

“…Four studies which analyzed a change of BMD at the lumbar spine in patients receiving oral isotretinoin showed its slight increase (1.1–3.0%) in contrast to the reported decrease at long bones [6, 22, 26, 27]. This change remained however in a normal range for young adolescents who typically manifest an increase in bone density 0.5–7.0% yearly [27].…”

Adverse Events in Isotretinoin Therapy: A Single-Arm Meta-Analysis

“…In opposite, a prospective study by Leachman et al from 1999 presented that bone density in young men (aged 17–25 years) after receiving oral isotretinoin for cystic acne was lower at all sites (spine, femoral neck, and Ward triangle) was considerably more variable at the spine even before treatment. A potential explanation could be a significant decrease within 5 days of treatment ( p < 0.05) of markers of bone turnover, e.g., serum osteocalcin, the carboxyterminal propeptide of type I collagen, bone-specific alkaline phosphatase, the carboxyterminal telopeptide of type I collagen, and urine levels of calcium and hydroxyproline, serum calcium and parathyroid hormone, which were presented in a clinical trial of Kindmark et al On the positive side is the fact that the abnormal levels of these markers returned to baseline values within 14 days [ 70 , 71 , 72 ].…”