Type 2 diabetes mellitus and osteoprosis
Conditions
Interventions
Type 2 diabetes bisphosphonate treatment group:Alendronate sodium treatment was 70mg/ time, once a week oral. Zoledronic acid was given 5mg/ time intravenously, only once in 12 months
Type 2 diabetes treated with desomumab group:Desomumab, 60mg/ time, subcutaneous injection every 6 months in the abdomen.
No type 2 diabetes bisphosphonate treatment group:Alendronate sodium treatment was 70mg/ time, once a week oral. Zoledronic acid was given 5mg/ time intravenously, only once in 12 months
No type 2 diabetes desomumab treatment group:Desomumab, 60mg/ time, subcutaneous injection every 6 months in the abdomen.
Sponsors
Tongji Hospital, Tongji University School of Medicine
Eligibility
Sex/Gender
All
Age
65 Years to 80 Years
Inclusion criteria
Inclusion criteria: ? Postmenopausal women aged 65-80 years (including 65 and 80 years) at the time of signing the informed consent; ? The general condition is good, and the daily life does not need to rely on others to help; ? All patients meet the WHO's osteoporosis diagnostic criteria (1994):T-value of bone mineral density in the lumbar spine or hip measured by dual-energy X-ray absorptiometry=-2.5; Patients with type 2 diabetes mellitus meet the WHO diagnostic criteria for type 2 diabetes (1999). ? No bone resorption inhibitors have been used before, including alendronate, zoledronic acid and ibandronic acid and denosumab. ? Good medication compliance; ? Follow up in time according to the requirements of the study; ? Willingness to sign written informed consent and comply with the study protocol.
Exclusion criteria
Exclusion criteria: ? Patients with the following diseases:history of cardiovascular and cerebrovascular disease, defined as: within 6 months prior to screening, the subject had have myocardial infarction, coronary angioplasty or bypass, valvular heart disease or heart valve repair, have clinical unstable arrhythmia, unstable angina pectoris, transient ischemic attack, cerebrovascular accident disease history; congestive heart failure rated III or IV by the New York Heart Association (NYHA); at the time of screening already hypertension (systolic blood pressure =160mmHg or diastolic blood pressure =100mmHg at screening) that remains uncontrolled with stable doses (at least 4 weeks) of antihypertensive drugs ;a history of unstable or rapidly progressing kidneys, defined as glomerular filtration rate<30ml/min/1.73m2; active liver disease at the time of screening, defined as serum aminotransferase two higher than the upper limit of normal or total bilirubin higher than the normal; a history of clearly diagnosed mental illness; have hemoglobinopathy (e.g. Sickle, rotocytic anemia ,thalassemia, sideroblastic anemia); immunocompromised subjects, such as subjects who have received an organ transplant or have been diagnosed with human immunodeficiency virus infection (such as HIV); there is any type of malignancy Tumor (cured or not); clinically diagnosed type 1 diabetes, diabetes due to pancreatic injury, or other conditions different types of diabetes mellitus; ? Have caused secondary osteoporosis disease or drug use; ? TZDs hypoglycemic agents were used within 1 year before screening and during follow-up; ? Serum 25 hydroxyvitamin D<12ng/ml; ? Has been registered in other drug trials or completed less than 1 month; ? There are bisphosphonate or desumab treatment contraindications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lumbar and hip bone mineral density;Drug-related adverse events;all sites fractures; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in bone turnover index;short physical performance battery;VAS score for pain; | — |
Countries
China
Contacts
Public ContactLige Song
Shanghai Tongji Hospital
Outcome results
None listed