Trial results for a study investigating bone pain in Sickle Cell Disease were posted on ClinicalTrials.gov on 2025-08-24, involving 53 participants and revealing a statistically significant difference (p=0.013) in femoral neck bone mineral density between groups.
Background
Sickle Cell Disease (SCD) is a genetic blood disorder that can lead to various complications, including chronic pain. Patients with SCD often experience bone-related issues such as low bone mineral density (BMD), osteopenia, and osteoporosis, which can contribute to their pain burden. Understanding the association between bone health and pain in adults with SCD is crucial for improving patient management and quality of life.
Trial design
This prospective study, designated as Phase NA, enrolled 53 participants and is currently active, though not recruiting. The study investigated conditions including Sickle Cell Disease, Sickle Cell Anemia, Low Bone Density, Osteoporosis, and Osteopenia. Its primary objective was to determine how low bone mineral density and/or vertebral compression fractures associate with pain in adults with sickle cell disease. The results presented compare measurements between two undefined groups, Group A and Group B.
Key results
The trial reported several key measurements related to bone mineral density (BMD) and Z-scores, comparing Group A and Group B:
- Lumbar Spine Bone Mineral Density:
- Group A median: 0.97 g/cm2
- Group B median: 1.0 g/cm2
- Lumbar Spine Bone Mineral Density-Z-scores:
- Group A median: -1.35 Z-score
- Group B median: -1.60 Z-score
- Total Hip Bone Mineral Density (BMD):
- Group A median: 0.90 g/cm2
- Group B median: 1.03 g/cm2
- Total Hip Bone Mineral Density-Z-scores:
- Group A median: -0.75 Z-score
- Group B median: -0.5 Z-score
- Femoral Neck Bone Mineral Density (BMD):
- Group A median: 0.77 g/cm2
- Group B median: 0.94 g/cm2
- Femoral Neck Bone Mineral Density Z-scores:
- Group A median: -0.95 Z-score
- Group B median: -0.60 Z-score
Statistical analyses comparing Group A and Group B yielded the following p-values:
- For Lumbar Spine Bone Mineral Density (Wilcoxon rank-sum test): p=0.321
- For Lumbar Spine Bone Mineral Density-Z-scores (Welch two sample t-test): p=0.714
- For Total Hip Bone Mineral Density (Wilcoxon rank-sum test): p=0.09
- For Total Hip Bone Mineral Density-Z-scores (Welch two sample t-test): p=0.604
- For Femoral Neck Bone Mineral Density (Wilcoxon rank-sum test): p=0.013
- For Femoral Neck Bone Mineral Density Z-scores (Welch two sample t-test): p=0.166
A p-value of less than 0.05 was considered statistically significant. Therefore, a statistically significant difference was observed only for Femoral Neck Bone Mineral Density (p=0.013) between Group A and Group B.
What this means
The results indicate that while several bone mineral density measurements were compared between two groups of individuals with Sickle Cell Disease, a statistically significant difference was specifically identified in the femoral neck bone mineral density (BMD) (p=0.013). This suggests that there may be distinct differences in bone health at this particular site between the two groups. However, no statistically significant differences were found for lumbar spine BMD or total hip BMD, or for femoral neck BMD Z-scores. The study's broader aim to associate bone density with pain was not detailed in the posted results, which focused solely on bone density measurements and their statistical comparison between groups.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05283148, titled "Sickle Cell Disease (SCD) Bone Pain Study", were posted on 2025-08-24 on clinicaltrials.gov.