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

January 29, 2026 updated by: Mishaela Rubin, Columbia University
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.

Study Overview

Status

Completed

Conditions

Detailed Description

T1D is primarily associated with decrements in bone strength due to disrupted microarchitecture occurring during peak bone mass accrual, and this disruption arises from hyperglycemia and glycemic variability. Impaired bone development during this period likely predisposes to an increased fracture risk across the lifespan.

The investigators will compare baseline, 12 month and 24 month changes in High-resolution peripheral quantitative computed tomography/micro-finite element analysis (HR-pQCT/μFEA)-based estimates of bone strength and bone turnover by biochemical measurements in 40 T1D children at the onset of peak bone mineral accretion (n=40) versus sex and puberty-matched healthy controls (n=40). The investigators will determine relationships between changes in bone strength (including trabecular and cortical components) and measures of glycemic control and variability by continuous glucose monitoring (CGM).

Study Type

Observational

Enrollment (Actual)

86

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center-Harkness Pavillion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 14 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

40 children and adolescents between the age of 8 to 14 years with type 1 diabetes and 40 children and adolescents between the age of 8 to 14 years without type 1 diabetes.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Group 1
Those with Type 1 Diabetes.
Group 2
Those without Type 1 Diabetes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in microarchitecture by HR-pQCT
Time Frame: Two Years
Measures of HRpQCT
Two Years
Change in bone mineral density by Dual X-ray Absorptometry (DXA)
Time Frame: Two Years
Measures of DXA
Two Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Mishaela Rubin, MD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

September 8, 2025

Study Completion (Actual)

September 8, 2025

Study Registration Dates

First Submitted

February 2, 2020

First Submitted That Met QC Criteria

February 27, 2020

First Posted (Actual)

February 28, 2020

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAS5630
  • R01DK122564 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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