Skeletal Effects of Type 1 Diabetes on Low-Trauma Fracture Risk
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age50+
SponsorCreighton University
About this trial
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
Eligibility criteria
Qualifiers
No chronic disease diagnoses that may affect bone, as confirmed by the PI.
Normal clinical history, physical, and clinical laboratory exam (except for usual complications of a 10+-year diabetic, i.e., ~minimal neuropathy or retinopathy, known, but asymptomatic mild vascular disease, etc.)
Glomelular Filtration Rate (GFR) >45 ml/min (Renal Association lower limit for "mild" kidney failure).
Willingness to sign a consent form.
Disqualifiers
Women who have had Type 1 diabetes for less than 10 years.
Non-insulin dependent Type 1 diabetic.
Less than 50 years old.
Less than 5 years post menopausal.
Trial design
Treatments tested in this trial
- Transilial bone biopsy
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov