Status:
COMPLETED
Markers of Bone Status in Diabetes Mellitus (Type 1 and Type 2)
Lead Sponsor:
Jakob Starup Linde
Conditions:
Diabetes Mellitus
Osteoporosis
Eligibility:
All Genders
50+ years
Brief Summary
Objective To collate the bone status in type 1 and type 2 diabetics using biochemical markers and bone scans. Methods: This is a multicenter trial involving the University Hospitals of three major d...
Detailed Description
Diabetes Mellitus and Osteoporosis are common conditions. Patients with Diabetes Mellitus are known to have more fractures than their non-diabetic counterparts. However bone mineral density (BMD) whic...
Eligibility Criteria
Inclusion
- Type 1 or type 2 diabetes.
- Age ≥ 50 years.
- Unaltered treatment of diabetes during the previous six months (no changes in drugs, but an increase or decrease in dose is accepted) and HbA1c is stable with a level of ± 1 in the same period.
- HbA1c level≥ 7 % through the previous six months.
- BMI between 19 og 35.
- Specific inclusion criteria for type 2 diabetes:
- Either treatment with metformin, sulfonylureas, dipeptidyl peptidase IV (DPP IV) inhibitors or glucagon-like peptide 1 (GLP-1) analogs.
- Treatment with insulin and insulin in the combination with metformin, sulfonylureas, DPP IV inhibitors or GLP-1 analogs.
Exclusion
- HbA1C \> 10%
- Pregnancy.
- Metal implanted at both ankles and wrists.
- Patients treated with: Antiresorptive (incl. hormone replacement therapy) or bone anabolic treatment, glucocorticoids, lithium and anticonvulsives.
- Patients with a bone disease other than osteoporosis.
- Vertebral fracture visible by vertebral fracture assessment (VFA).
- Patients with renal disease defined by estimated glomerular filtration rate(eGFR) \< 50.
- Other medical disease in unstable phase (fx. cancer, hyperthyroidism).
- Heart failure; New York Heart Association (NYHA) class IV.
- Patients which the investigator does not believe is fit to participate in the study
Key Trial Info
Start Date :
March 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
197 Patients enrolled
Trial Details
Trial ID
NCT01870557
Start Date
March 1 2013
End Date
May 1 2015
Last Update
May 28 2015
Active Locations (2)
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1
Department of Endocrinology, Aalborg University Hospital
Aalborg, Denmark, 9000
2
Department of Endocrinology and Internal Medicine, Aarhus University Hospital
Aarhus, Denmark, 8000