Bone Mineral Density to Assess Pediatric Bone Health in Drug Development
Abstract
BACKGROUND: Pediatric bone health is an important part of the safety assessment of inhaled corticosteroids and certain other drugs. Current regulatory guidance for assessment of bone health for intranasal and inhaled corticosteroid drugs is a single 1-year study of linear growth.
OBJECTIVE: The objective of this study was to assess whether a significant change in bone mineral density (BMD) could be observed during a 12-month period in pediatric patients being treated for asthma with an inhaled corticosteroid using a previously conducted study.
METHODS: The publicly available information from the Childhood Asthma Management Program (CAMP) study was used to assess whether a statistically significant difference in BMD could be detected over a 1-year period. Patients who were at Tanner stage ≥2 were excluded from analysis as is stated in the present FDA Guidance on growth studies with inhaled corticosteroids, and children with any use of oral corticosteroids were also excluded. A comparison in BMD change over time (bone mineral accretion [BMA]) between baseline and 12 months of follow-up was made for the placebo and inhaled budesonide groups using multiple regression analysis to account for age, race, and gender as covariates.
RESULTS: From the original 1041 patients in the CAMP study, 74 patients met the criteria for evaluation, with 42 patients receiving budesonide and 32 placebo patients. Children randomized to budesonide had a lower mean BMA than those receiving placebo…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 1,041 participants or records.
Read the paper
Related studies
- Development of a crushable foam model for human trabecular bone
- Data-driven motion compensation in HR-pQCT.
- Modeling of structure, quality, and function in the orthodontic patient
- Exploring the mechanism of Heidihuang Pill in the treatment of osteoporosis based on network pharmacology, molecular docking, and experimental validation
- Effect of fabric on the accuracy of computed tomography-based finite element analyses of the vertebra
- Use of interventions involving virtual reality tasks during the climacteric: a systematic review
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.