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Cystic Fibrosis for Cystic Fibrosis

N/A
Recruiting
Led By Rebecca Gordon, MD
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and one year follow-up
Awards & highlights

Study Summary

The investigators will be evaluating bone marrow composition via magnetic resonance imaging in adolescents diagnosed with cystic fibrosis (CF) compared to healthy, matched controls. The investigators will also be assessing their bone mineral density via other imaging modalities, including dual-energy X-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT). This longitudinal project will focus on abnormalities in bone marrow composition, and specifically whether adolescents with diagnosed with CF exhibit increased bone marrow fat, its association with bone mineral density (BMD) and the underlying pathophysiology, including glycemic control, inflammation, and bone turnover markers.

Eligible Conditions
  • Cystic Fibrosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and one year follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and one year follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bone marrow adiposity by magnetic resonance relaxometry (MR relaxometry)
Bone marrow adiposity by magnetic resonance spectroscopy (MRS)
Secondary outcome measures
Hip BMD Z-score by DXA
Spine BMD Z-score by DXA
Total body bone mineral density Z-score by Dual-energy X-ray absorptiometry (DXA)
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cystic FibrosisExperimental Treatment5 Interventions
This group will be 36 adolescents, ages 13-20 years old, who have been diagnosed with cystic fibrosis. All participants will have a two study visits approximately one year apart during which the listed diagnostic testing will be performed.
Group II: ControlExperimental Treatment5 Interventions
Controls will be matched for age, Tanner staging, BMI percentile, and ancestry. All participants will have a two study visits approximately one year apart during which the listed diagnostic testing will be performed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DXA
2010
N/A
~610
Blood Draw
2006
Completed Phase 4
~2400
Magnetic resonance spectroscopy
2008
N/A
~40
pQCT
2010
N/A
~330

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
762 Previous Clinical Trials
5,579,898 Total Patients Enrolled
17 Trials studying Cystic Fibrosis
1,676 Patients Enrolled for Cystic Fibrosis
Cystic Fibrosis FoundationOTHER
189 Previous Clinical Trials
37,174 Total Patients Enrolled
182 Trials studying Cystic Fibrosis
34,237 Patients Enrolled for Cystic Fibrosis
Rebecca Gordon, MDPrincipal InvestigatorBoston Children's Hospital
2 Previous Clinical Trials
142 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Pediatric RadiologyJournal
Bone Marrow Fat Content in 70 Adolescent Girls with Anorexia Nervosa: Magnetic Resonance Imaging and Magnetic Resonance Spectroscopy Assessment
Ecklund, Kirsten, Sridhar Vajapeyam, Robert V. Mulkern, Henry A. Feldman, Jennifer M. O’Donnell, Amy D. DiVasta, and Catherine M. Gordon. 2017. “Bone Marrow Fat Content in 70 Adolescent Girls with Anorexia Nervosa: Magnetic Resonance Imaging and Magnetic Resonance Spectroscopy Assessment”. Pediatric Radiology. Springer Science and Business Media LLC. doi:10.1007/s00247-017-3856-3.
BoneJournal
Magnetic Resonance Imaging and Spectroscopy Evidence of Efficacy for Adrenal and Gonadal Hormone Replacement Therapy in Anorexia Nervosa
Vajapeyam, Sridhar, Kirsten Ecklund, Robert V. Mulkern, Henry A. Feldman, Jennifer M. O'Donnell, Amy D. DiVasta, Clifford J. Rosen, and Catherine M. Gordon. 2018. “Magnetic Resonance Imaging and Spectroscopy Evidence of Efficacy for Adrenal and Gonadal Hormone Replacement Therapy in Anorexia Nervosa”. Bone. Elsevier BV. doi:10.1016/j.bone.2018.02.021.
Journal of Bone and Mineral ResearchJournal
Bone Marrow Changes in Adolescent Girls with Anorexia Nervosa
Ecklund, Kirsten, Sridhar Vajapeyam, Henry A Feldman, Catherine D Buzney, Robert V Mulkern, Paul K Kleinman, Clifford J Rosen, and Catherine M Gordon. 2009. “Bone Marrow Changes in Adolescent Girls with Anorexia Nervosa”. Journal of Bone and Mineral Research. Wiley. doi:10.1359/jbmr.090805.
clinicaltrials.govStudy
Skeletal Health and Bone Marrow Composition in Adolescents With Cystic Fibrosis
Rebecca Gordon 2024. "Skeletal Health and Bone Marrow Composition in Adolescents With Cystic Fibrosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06216704.
~24 spots leftby Dec 2028
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