DENOSUMAB for Type 2 diabetes|Postmenopausal osteoporosis

Inclusion criteria

• {"criterion_text":"- Postmenopausal women (postmenopausal for at least two years)"}
• {"criterion_text":"- Age ≥ 40 years"}
• {"criterion_text":"- BMD T-score ≥ -2.0 (lumbar spine, total hip or femoral neck)"}
• {"criterion_text":"- At least 2 lumbar vertebrae that can be evaluated by dual-energy x-ray absorptiometry (DXA)"}
• {"criterion_text":"- Diabetes Mellitus type 2"}
• {"criterion_text":"- Treatment with metformin as monotherapy"}

Exclusion criteria

• {"criterion_text":"- Treatment for osteoporosis at any time"}
• {"criterion_text":"- Unable to read and understand Danish"}
• {"criterion_text":"- Immobility"}
• {"criterion_text":"- Other antidiabetic medication than metformin"}
• {"criterion_text":"- Low-energy vertebral fractures at any time"}
• {"criterion_text":"- Low-energy hip fracture at any time"}
• {"criterion_text":"- Ongoing treatment with systemic glucocorticoids"}
• {"criterion_text":"- Metabolic bone disease (for example osteogenesis imperfecta, Paget's disease of bone, hyperparathyroidism)"}
• {"criterion_text":"- Treatment affecting bone, calcium metabolism or muscle"}
• {"criterion_text":"- Active cancer within the last 5 years with the exception of basal cell skin cancer"}
• {"criterion_text":"- Estimated glomerular filtration rate (eGFR) ≤ 35 mL/min"}

Primary endpoints

• {"endpoint_text":"- Changes in muscle mass and muscle strength from baseline to month 12.","definition_or_measurement_approach":"Change measured from baseline to month 12 (no further measurement method specified in source)"}
• {"endpoint_text":"- Changes in insulin sensitivity (Hb1Ac, HOMA-IR, fasting glucose, oral glucose tolerance test (OGTT)) from baseline to month 12.","definition_or_measurement_approach":"Insulin sensitivity assessed by HbA1c, HOMA-IR, fasting glucose and oral glucose tolerance test (OGTT) from baseline to month 12"}

Secondary endpoints

• {"endpoint_text":"- Changes in DPP-4 and GLP-1 from baseline to month 12.","definition_or_measurement_approach":"Changes measured from baseline to month 12 (specific assays not specified)"}
• {"endpoint_text":"- Changes in carboxy-terminal collagen crosslinks (CTX) and procollagen type I N-terminal propeptide (PINP) from baseline to month 12.","definition_or_measurement_approach":"Changes in CTX and PINP measured from baseline to month 12"}
• {"endpoint_text":"- Change in lumbar spine BMD from baseline to month 12.","definition_or_measurement_approach":"Lumbar spine bone mineral density change measured from baseline to month 12 (method: DXA implied elsewhere)"}
• {"endpoint_text":"- Change in advanced glycation end products (AGEs) from baseline to month 12.","definition_or_measurement_approach":"AGEs measured from baseline to month 12 (specific assay not specified)"}
• {"endpoint_text":"- Changes in muscle strength from baseline to month 1 and 3.","definition_or_measurement_approach":"Muscle strength assessed at baseline and at months 1 and 3"}
• {"endpoint_text":"- Changes in insulin sensitivity (Hb1Ac, HOMA-IR, and fasting glucose) from baseline to month 1 and 3","definition_or_measurement_approach":"Insulin sensitivity assessed by HbA1c, HOMA-IR and fasting glucose at baseline and months 1 and 3"}

Denmark

Earliest CTIS Part Ii Submission Date

26-02-2024

Latest Decision Or Authorization Date

26-03-2024

Processing Time Days

29

Number Of Sites

1

Number Of Participants

40

Primary sponsor

Full Name

Region Midtjylland

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"sponsorDuties code 1 (id 191504)","organisation_type":"Educational Institution"}