Effect of Thiazolidinediones on Human Bone

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

We will prospectively study 2 groups of diabetic patients treated with pioglitazone or placebo for 26 weeks. Bone marrow aspirates will be obtained from these patients at baseline and after 26 weeks of treatment, and hBMCs will be isolated from these bone marrow aspirations. The ability of hBMCs to differentiate into osteoblast and adipocytes lineages will be compared before and after treatment with pioglitazone and compared to placebo. In parallel, clinical markers of bone formation and resorption as well as bone mineral density will be assessed before and after 26 weeks of treatment. Primary endpoint for this study will be detection of change in number of osteoblasts or adipocytes from cultured hBMCs between study groups and within each group.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Treatments: 2,4-thiazolidinedione; Pioglitazone

Criteria

Inclusion Criteria:Subjects with T2DM who are:

• naïve to insulin and TZD therapy

• On diet and lifestyle therapy along with submaximal metformin therapy

• with HbA1c between 7% and 8.0%

• between the ages of 18 and 80 years

• both genders

Exclusion Criteria:

• Contraindications to TZD therapy including congestive heart failure class III or IV, and/or macular edema

• history of osteoporosis (T score < -2.5 on DXA scanning) or osteoporotic fragility fracture

• treatment with glucocorticoids within 1 year of study enrollment

• treatment with bisphosphonates,calcitriol, raloxifene, Calcitonin, estrogen

• vitamin D insufficiency, defined as 25(OH)D levels <30 ng/mL or

• hyperparathyroidism

• liver disease (LFTS > 3x upper limits of normal)

• Kidney disease Cr>1.4 in females and Cr>1.5 in males

• smokers (active or within a month from stopping)

• alcohol or drug abuse/dependence

• hypogonadism in males

• mental conditions rendering the subject unable to understand the scope of the study

• female subjects who are pregnant or breast feeding

• chronic obstructive pulmonary disease

• obstructive sleep apnea.