Related Experiment Video
Updated: Feb 5, 2026
Scanning Skeletal Remains for Bone Mineral Density in Forensic Contexts
Published on: January 29, 2018
Bone Mineral Density to Assess Pediatric Bone Health in Drug Development
Brian M Maas1, Jian Wang2, Freda Cooner3
11 University of North Carolina Eshelman School of Pharmacy, Chapel Hill, NC, USA.
Insights
A 12-month study found that bone mineral accretion (BMA) in children using inhaled corticosteroids for asthma showed significant changes. This suggests BMA may be a useful measure for pediatric bone health assessments in drug safety evaluations.
Area of Science:
- Pediatric pharmacology
- Bone metabolism
- Respiratory medicine
Background:
- Pediatric bone health is crucial for evaluating inhaled corticosteroid (ICS) safety.
- Current regulatory guidelines rely on a single 1-year linear growth study for ICS bone health assessment.
Purpose of the Study:
- To determine if significant changes in bone mineral density (BMD) could be detected within 12 months in pediatric asthma patients using ICS.
- To evaluate the utility of bone mineral accretion (BMA) as a biomarker for pediatric bone health.
Main Methods:
- Utilized publicly available data from the Childhood Asthma Management Program (CAMP) study.
- Analyzed BMD changes (BMA) over 12 months in pediatric patients treated with inhaled budesonide versus placebo.
- Excluded patients at Tanner stage ≥2 and those with oral corticosteroid use, adhering to FDA guidance.
Main Results:
- Out of 1041 original participants, 74 met the analysis criteria (42 budesonide, 32 placebo).
- Children receiving inhaled budesonide exhibited a lower mean BMA (0.021 g/cm²/y) compared to the placebo group (0.036 g/cm²/y).
Conclusions:
- Significant changes in BMA can be observed over 12 months in a select pediatric population using inhaled corticosteroids.
- BMA measurement may be considered for assessing pediatric bone health for certain drugs, particularly those with potential bone toxicity signals.
- Further research is needed to establish the clinical relevance of BMA changes and their correlation with pediatric bone health outcomes.
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 (0.021 ± 0.023 [SD] g/cm2/y vs 0.036 ± 0.025 [SD] g/cm2/y).
Conclusion:
In a select pediatric patient population, a significant change in BMA can be observed over 12 months on an inhaled corticosteroid. Based on this post hoc analysis, measurement of BMA as an assessment of pediatric bone health may be considered for certain drugs, especially when there is a potential signal of bone toxicity from animal or human data. The clinical relevance of this finding is presently unknown, and more data on the relationship between changes in BMA and clinical pediatric bone health outcomes are needed.
Related Concept Videos
01:31Essential Minerals for Bone Health
Calcium and Phosphorus
Calcium is a critical component of bones, especially in the form of calcium phosphate and calcium carbonate. Since the body cannot make calcium, it must be obtained from the diet. However, calcium cannot be absorbed from the small intestine without...
01:25Role of Vitamins in Maintaining Bone Health
Vitamin A
Vitamin A is involved in the process of bone remodeling. Retinoic acid, the active metabolite of Vitamin A, has nuclear receptors in osteoblasts and osteoclasts, which are involved in bone remodeling.
Vitamin B12
Vitamin B12 acts as a cofactor during the formation of osteoblast-related proteins, such as osteocalcin. Vitamin B12 plays a role...
01:55Bone Structure
01:40Bone Remodeling
01:27Compact Bone
Compact bone, also called cortical bone, is the denser, stronger of the two types of bone tissue. It is found under the periosteum and in the diaphyses of long bones, where it provides support and protection. The microscopic structural unit of compact bone is called an osteon, or haversian system. Each osteon is composed of concentric rings of calcified...
01:29Bone Disorders
Bone deposition is also affected by the levels of sex hormones like estrogen and testosterone that promote osteoblast activity and bone matrix synthesis. When the level of these hormones decreases due to aging, it causes a reduction in bone deposition. As a result, bone resorption by osteoclasts...