2024-514148-99-00招募中4 期
Markers of bonestatus in Diabetes Mellitus patients (type 1 and type 2) and the effect of antiresorptive treatment on glycemic markers
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- HbA1c and BMD
研究概览
简要总结
To investigate the effect of Alendronate on bone markers and glycemic markers
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
HbA1c and BMD
HbA1c and BMD
次要结局
- Insulin, plasmaglucose, HOMA-IR, hs-CRP, AGE markers, lipids, adiponectin, PTH, 25 og 1,25 vitamin D, bone specific alkaline phosphatase, FSH, LH, testestoron/østradiol, creatinine, GFR, FGF23, sclerostin, osteocalcin, ucOC, P1NP, PICP, CTX, osteoprotegrin, RANKL and pentosidine. Urine albumin/creatinine ratio and urine bone markers. HRpQCT scan results. Analysis results by fat tissue-, muscle tissue- and bone biopsies. Life style questionnaire including diet and physical activity.
研究者
Peter Vestergaard
Scientific
Aalborg University Hospital
研究点 (1)
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