A Study to Assess Bone Quality Characteristics, Comparing Type 2 Diabetes Patients who have or have not had Prior Fragile Bone Fractures

Overview

About this study

The purpose of this study is to assess key characteristics of bone quality, specifically material strength and porosity, in patients who have type 2 diabetes. These patients are at an unexplained increased risk for fractures and there is an urgent need to refine clinical assessment for this risk.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria:

  • Women and men ≥ 50 years old.
  • All women must be postmenopausal (serum follicle stimulating hormone [FSH] > 20 IU/L).  
  • All subjects will be defined as having a median hemoglobin A1c level ≥ 6.5% within the past 5 years.  
  • Non-vertebral fragility fracture subjects will be defined as those having had one of the following fractures which are clearly associated with low BMD (22,72) and occur at sites with substantial amounts of cortical bone (in contrast to the vertebrae, which have an extremely thin cortical shell (73)) following mild to moderate trauma (i.e., in the course of daily activities or falls from standing height or less (69)) within the previous 10 years:
    • proximal femur;
    • proximal humerus;
    • distal forearm;
    • other femoral sites (e.g., shaft);
    • other upper extremity sites (but excluding hands and fingers);
    • pelvis;
    • ribs;
    • clavicle;
    • scapula;
    • sternum;
    • tibia/fibula (but excluding ankle fractures, which are not associated with BMD).
  • For subjects seen at the University of Mississippi, an equal number of female subjects with T2DM and without T2DM.  
  • Anyone with fractures will not be excluded.

Exclusion Criteria: 

  • Subjects with fractures only of the skull and face, hands and fingers, feet and toes, patella, and ankle, which are not closely associated with BMD in most studies.
  • Anyone with pathological fractures (e.g., malignancy).  
  • Non-fracture controls if they have a fracture history including clinical (symptomatic or incidentally discovered) vertebral fractures.   
  • Significant abnormality in any of the screening laboratory studies.
  • Presence of stage IV or V chronic kidney disease, chronic liver disease, severe neuropathic disease, unstable cardiovascular disease, malignancy, chronic gastrointestinal disease, autoimmune rheumatologic conditions (e.g., rheumatoid arthritis), hypo- or hyperparathyroidism, Cushing’s syndrome, severe chronic obstructive pulmonary disease, alcoholism, or type 1 diabetes.
  • Treatment with any of the following drugs: oral corticosteroids (inhaled corticosteroids ok for inclusion)(> 3 months at any time or > 10 days within the previous year); treatment within the past year with any of the following:
    • anticonvulsants (except gabapentin as it has no effect on bones);
    • pharmacological doses of thyroid hormone (causing thyroid stimulating hormone [TSH] decline below normal);
    • adrenal or anabolic steroids;
    • aromatase inhibitors;
    • calcitonin;
    • estrogen (E);
    • selective E receptor modulators (SERMs);
    • parathyroid hormone (PTH);
    • denosumab;
    • SGL2 inhibitors;
    • thiazolidinediones.  
  • Subjects who have been exposed to a bisphosphonate within the past 5 years.
  • All subjects will be required to have sufficient levels of vitamin D (serum 25-hydroxyvitamin D [25-(OH)D] >15 ng/ml) to exclude patients who may have osteomalacia.
  • A complete list of current and past medications, including the duration and dose of diabetic medications must be provided.

 

 

 

 

 

 

 

 

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Sundeep Khosla, M.D.

Open for enrollment

Contact information:

Amanda Tweed

7756663

Tweed.Amanda@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20228965

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