Comparison of Bone Quality in Subjects with or without Type 2 Diabetes

Overview

About this study

The purpose of this study is to test the hypothesis that patients with T2DM will have greater deterioration in BMSi and in cortical porosity over 3 yrs as compared to sex- and age-matched non-diabetic controls; and identify the circulating hormonal (e.g., estradiol [E2], testosterone [T]) and biochemical (e.g., bone turnover markers, AGEs) determinants of changes in these key parameters of bone quality, and evaluate the possible relationship between existing diabetic complications and skeletal deterioration over time in the T2DM patients.

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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Women and men ≥ 50 years old without a history of fragility fracture.
  • All women will be postmenopausal (serum follicle stimulating hormone [FSH] > 20 IU/L). 
  • All T2DM subjects will be defined as having a hemoglobin A1c level ≥ 6.5% within the past 5 years per the American Diabetes Association; matched non-diabetic controls will be defined as having a hemoglobin A1c < 5.7% (28)]. 
  • Subjects with fractures only of the skull and face, hands and fingers, feet and toes, patella, and ankle, sites which are not closely associated with BMD in most studies, are eligible for inclusion. 

Exclusion Criteria:

  • Non-vertebral fragility fracture subjects as those having had one of the following fractures which are clearly associated with low BMD and occur at sites with substantial amounts of cortical bone (in contrast to the vertebrae, which have an extremely thin cortical shell following mild to moderate trauma (i.e., in the course of daily activities or falls from standing height or less 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, and tibia/fibula (but excluding ankle fractures, which are not associated with BMD).
  • Anyone with pathological fractures (e.g., malignancy) will be excluded.  
  • Morbid obesity (BMI ≥ 40 kg/m²).
  • 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.
  • Significant skin disease, bruising, local edema, or infection over the microindentation site (anterior tibia)
  • 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, or thiazolidinediones. 
  • Undergoing treatment for blood clots, coagulation defects, or 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, pharmacological doses of thyroid hormone (causing thyroid stimulating hormone [TSH] decline below normal), adrenal or anabolic steroids, aromatase inhibitors, calcitonin, estrogen. 
  • Selective E receptor modulators (SERMs), parathyroid hormone (PTH), denosumab, or 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. 
  • Subjects will be required to provider a complete list of current and past medications, including the duration and dose of diabetic medications.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Sundeep Khosla, M.D.

Open for enrollment

Contact information:

Amanda Tweed

(507)255-6663

Tweed.Amanda@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

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