CompletedNot Applicable

Skeletal Fragility in Type 1 Diabetes: Glycemic Control and Bone Strength

United States86 participantsStarted 2020-01-01

Plain-language summary

The purpose of this research study is to find out how bones are affected in children and adolescents with type 1 diabetes (T1D) as compared to children and adolescents without type 1 diabetes.

Who can participate

Age range

8 Years – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria (T1D and Controls): \- Children within 2 years preceding the onset of the pubertal growth spurt Inclusion Criteria (T1D participants): \- documentation of β-cell autoimmunity and need for insulin replacement Exclusion Criteria: * Estimated glomerular filtration rate (eGFR)\< 60 ml/mim * 25(OH)D level \< 20 ng/ml. * Celiac disease * Autoimmune thyroid disease * Addison's disease * History of pathological fractures \-- Disorders associated with altered skeletal structure or function * Bone active drugs in past year * Diabetes of other or unclear etiology

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in microarchitecture by HR-pQCT

Timeframe: Two Years

Change in bone mineral density by Dual X-ray Absorptometry (DXA)

Timeframe: Two Years

Trial details

NCT IDNCT04289727

SponsorColumbia University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-09-08

View on ClinicalTrials.gov More Type1diabetes trials

Who can participate

Age range

8 Years – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.