Skeletal Effects of Type 1 Diabetes on Low-Trauma Fracture Risk

NCT05701254 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2024-09-25

No results posted yet for this study

Summary

Patients with Type 1 Diabetes Mellitus (T1DM) have a higher risk of low-trauma (osteoporotic) fracture that is 7-12 times higher than non-diabetics. The bone density of people with Type 1 Diabetes is higher at the time of fracture than in non-diabetics. This suggests the presence of underlying bone tissue mechanical defects. The potential benefits to participants would be knowledge gained about their bone density and the results of laboratory tests. On a wider scale, there may be general benefits to society because the knowledge gained from this study may help better understand the effects of diabetes on bone health

Conditions

Interventions

PROCEDURE

Transilial bone biopsy

The transiliac bone biopsy will be performed on each subject under local anesthesia, and conscious sedation. From one skin incision located \~2cm posterior and inferior to the anterior-superior pelvic spine on one side of the pelvis, the investigators will obtain two iliac bone specimens, each 7.5 mm in diameter, cylindrical in shape, and including both inner and outer cortices and the intervening trabecular bone.

Sponsors & Collaborators

  • Creighton University

    lead OTHER

Principal Investigators

  • Mohammed Akhter, PhD · Creighton University Osteoporosis Research Center

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-18
Primary Completion
2024-12-31
Completion
2025-01-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05701254 on ClinicalTrials.gov