An exploratory assessment of the effect of bazedoxifene on glucose metabolism and bone quality in postmenopausal women with type 2 diabetes.
- Conditions
- Type 2 diabetes mellitus
- Registration Number
- JPRN-UMIN000010074
- Lead Sponsor
- Yokohama City University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 20
Not provided
1.Past history of bone fractures related to non-traumatic accident. 2.Current use of pioglitazone (regardless of treatment duration). 3.Current use of steroid hormones (regardless of treatment duration). 4.The patients with the thyroid function abnormality for which treatment is needed. 5.Current use of other medications for osteoporosis: Vitamin D: within 12 weeks after the suspension of administration. Vitamin K2:within 12 weeks after the suspension of administration. Bisphosphonates:within 24 weeks after the suspension of administration. The others SERM(raloxifene):within 24 weeks after the suspension of administration. PTH:within 24 weeks after the suspension of administration. 6.Past history of deep vein thrombosis. 7.Cancer bearing patients. 8.Patients determined to be inappropriate by physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes to be shown in levels of serum adiponectin during the period from the start of medication to the last medication after 12 weeks.
- Secondary Outcome Measures
Name Time Method 1.Changes to be shown on glucose metabolism markers, such as FPG, HbA1c (NGSP), IRI, s-CPR during the period from the start of medication to the last medeication after 12 weeks. 2.Changes to be shown on the bone quality markers, such as s-homocysteine, s-pentosidine, and also on the bone metabolism markers, such as TRAP-5b, u-CTX, NTX, osteocalcin, ucOC during the period from the start of medication to the last medeication after 12 weeks. 3.Changes to be shown on biochemical markers, such as TC, LDL-C, TG, HDL-C, hsCRP, ferritin, s-Cr, cystatin C during the period from the start of medication to the last medeication after 12 weeks. 4.Changes to be shown on the PWV during the period from the start of medication to the last medeication after 12 weeks.