Assessing Bone and Marrow Changes in Asthma Patients on Oral Steroids
CT-Based Changes in Bone and Marrow Among Patients on Oral Steroids
This study is trying to see how taking oral steroids affects bone health in young adults with severe asthma by comparing their bone density and structure to those not on steroids over six months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 12 (estimated) |
| Ages | 25 Years to 45 Years |
| Sex | All |
| Sponsor | University of Iowa Academic / other |
| Drugs / interventions | Denosumab, radiation |
| Locations | 1 site (Iowa City, Iowa) |
| Trial ID | NCT04518722 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the feasibility of using advanced CT-based imaging tools to measure changes in bone density, micro-structure, and marrow adipose tissue among patients with severe, persistent asthma who are either on chronic oral steroid treatment or not. The study will recruit 10 non-smokers aged 25-45 and will involve baseline and 6-month follow-up imaging using dual-energy X-ray absorptiometry and various CT scans. The goal is to analyze differences in bone health between the two groups over time, providing insights into the effects of oral steroids on bone and marrow.
Who should consider this trial
Good fit: Ideal candidates are non-smoking individuals aged 25-45 with a diagnosis of severe, persistent asthma, either on chronic oral steroids or not.
Not a fit: Patients who are pregnant, have a history of cancer, or have significant comorbidities such as dialysis or severe obesity may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of bone health in patients with asthma who require oral steroid therapy.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Inclusion (all subjects): * Diagnosis of severe, persistent asthma (defined as using both a long-acting beta-agonist AND a high-dose inhaled steroid) * Age 25-45 * Inclusion (oral steroid group): * Chronic treatment with oral steroids for at least 45 days but less than 1 year Exclusion Criteria: * Exclusion (all subjects): * Pregnant or breastfeeding * History of any cancer, excluding non-melanoma skin cancer * Currently receiving dialysis * History of any lower extremity fracture * Hip or knee replacement * Non-ambulatory * Greater than 10 pack-year smoking history * BMI \> 50 * Age \< 25 or \> 45 * Current or past use of FDA-approved medication for osteoporosis: Bisphosphonates (Alendronate/Fosamax, Ibandronate/Boniva, Risedronate/Actonel/Atelvia, Zoledronic Acid/Reclast) Calcitonin (Fortical, Miacalcin) Selective Estrogen Receptor Modulator (Raloxifene/Evista) Parathyroid Hormone Analogue (Teriparatide/Forteo) Monoclonal Antibody (Denosumab/Prolia)
Where this trial is running
Iowa City, Iowa
- University of Iowa — Iowa City, Iowa, United States (Recruiting)
Study contacts
- Principal investigator: Punam K Saha, PhD — University of Iowa
- Study coordinator: Taylor M Haynes, MS
- Email: taylor-haynes@uiowa.edu
- Phone: 319-356-1785
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.