Effect of Denosumab on Glucose Metabolism in Postmenopausal Osteoporotic Women with Prediabetes: a Study Protocol for a 12-month Multicenter, Randomized, Open-label, Controlled Trial

INTERVENTION: Experimental group:Denosumab;Control group:Alendronate; CONDITION: prediabetes;osteoporosis PRIMARY OUTCOME: glycosylated hemoglobin A1c; SECONDARY OUTCOME: glycosylated hemoglobin A1c;fasting plasma glucose;2 hours postprandial blood glucose;fasting plasma insulin; INCLUSION CRITERIA: (i) Postmenopausal osteoporotic women with prediabetes aged 60‐90 years; (ii) Osteoporosis is defined as subjects with a bone mineral density (BMD) T score of less than ‐2.5 but not less than ‐4.0 at the lumbar spine or total hip by dual‐energy X‐ray absorptiometry (DXA); (iii) Prediabetes is defined as: (1) FPG 100‐125 mg/dl, or (2) 2‐hour plasma glucose 140‐199 mg/dl, or (3) HbA1c 5.7%‐6.4%, according to the American Diabetes Association (ADA) 2010 criteria