ongitudinal analysis of bone microstructural changes under luseogliflozin treatment using second-generation High-Resolution peripheral Quantitative Computed Tomography (HR-pQCT) in elderly patients with type 2 diabetes
- Conditions
- type 2 diabetes
- Registration Number
- JPRN-UMIN000036202
- Lead Sponsor
- agasaki University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
Not provided
(1) Previous history of treatment with SGLT2 inhibitors (2) Complicated with bone metabolic disorders including osteomalacia, thyroid dysfunction, hyperparathyroidism or hypoparathyroidism that require any medical treatments (3) Administered any treatments for osteoporosis described below at present or within the past 12 months before enrolled into the study; bisphosphonate, vitamin D preparation, vitamin K preparation, calcium preparation, selective estrogen receptor modulator (SERM), anti-RANKL antibody (denosumab), anti-sclerostin antibody (romosozumab) or parathyroid hormone (teriparatide) (4) Treated with estrogen or testosterone (5) Complicated with diabetic retinopathy or/and diabetic neuropathy requiring therapeutic intervention (6) Sever renal dysfunction with eGFR <30 ml/min/1.73 m2 (7) Anemia with hemoglobin level under 10 g/dL (8) Complicated with malignancy (9) Hypersensitivity or allergy to the study drugs including luseogliflozin or metformin (10) Taking alcohol more than 20 g/day (11) Smoking cigarette within one year before enrolled into the study (12) Participated in other clinical trials within 6 months before enrolled into the study (13) Complicated with chronic liver disease with Child-Pugh score of more than or equal to 6 points. (14) BMI <18.5 kg/m2 (15) Judged as an unsuitable participant by the researchers.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in the predicted bone strength of radius and tibia calculated using HR-pQCT (kN/mm)
- Secondary Outcome Measures
Name Time Method Changes in the values of blood and biochemical tests. Changes in the bone mineral density at lumbar spine, femur, radius measured by dual-energy X-ray absorptiometry. Incidence of vertebral fracture or femoral fracture. Changes in the values of bone metabolic markers. Changes in the values related with cortical bone structure, travecular bone structure or bone morphology calculated using by HR-pQCT.