prediabetes
Conditions
Interventions
Control group:Alendronate
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
Female
Age
60 Years to 90 Years
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: (i) Patients with T2D or receiving any anti-diabetes medications within 8 weeks before screening; (ii) Patients with an active infection (e.g., HIV, active tuberculosis) or severe illness (e.g., severe cardiovascular disease, cancer, endocrine disorders); (iii) Patients with a history of severe allergy to denosumab or any component of the formulation; (iv) Patients with uncontrolled hypocalcemia; (v) Patients with a history of blood donation or blood loss of > 400 mL within the last year; (vi) Patients who plan to undergo invasive dental surgery within the next year (e.g., tooth extraction, dental implants, oral surgery).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| glycosylated hemoglobin A1c; | — |
Secondary
| Measure | Time frame |
|---|---|
| glycosylated hemoglobin A1c;fasting plasma glucose;2 hours postprandial blood glucose;fasting plasma insulin; | — |
Countries
China
Contacts
Public ContactHouchen Lyu
Chinese People’s Liberation Army General Hospital
Outcome results
None listed