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Markers of bonestatus in Diabetes Mellitus patients (type 1 and type 2) and the effect of antiresorptive treatment on glycemic markers

Phase 1
Conditions
Diabetes Mellitus and Osteopenia/Osteoporosis
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Registration Number
CTIS2024-514148-99-00
Lead Sponsor
Aalborg University Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
64
Inclusion Criteria

Type 1 diabetes / type 2 diabetes, Age = 50 år, Same medical diabetes treatment the last six months (dose changes is allowed) and HbA1c changes on ± 1 in the same period, HbA1c level= 6,7% in the last six months, Body mass index (BMI) between 19 og 35, DXA T-score: -3,5 til -0,5

Exclusion Criteria

HbA1C > 10%, Pregnancy, Metal implanted at ancle and wrist at all four ekstremities, Treatment by: Antiresorptives (inkl. HRT) or bone anabolic drugs, glucocorticoids, lithium and anticonvulsives, Patients with bone disease different from Osteoporosis, Vertebral fracture assessed by VFA, Patients with kidney disease defined by eGFR < 50, Other significant medical disease in unstable phase (like cancer or hyperthyroidism), Heart failure in NYHA class IV, Previous allergic reactions to the trial drug, Previous allergic reactions to tetracyklin, Abnormities in esophagus and other factors, which may delay the transit time in the esophagus, Unable to stand or sit for 30 consecutive minutes, The investigator considers the patient unfit to participate, Patient with no understanding of the extent of the trial.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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