N/A
N=10
Effect of Thiazolidinediones on Human Bone
Osteoblast · Adipocytes · Bone Density · Osteocalcin · Adiponectin
Bottom Line
View on ClinicalTrials.gov: NCT00927355 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: Percent Change in Number of Osteoblast and Adipocyte Colony Forming Units Cultured From Bone Marrow Stem Cells Harvested 6 Months After Treatment With Study Drug Compared to Baseline — 0; 12; 4; -7 percent change from baseline to 6months
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pioglitazone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Number of Osteoblast and Adipocyte Colony Forming Units Cultured From Bone Marrow Stem Cells Harvested 6 Months After Treatment With Study Drug Compared to Baseline |
0; 12; 4; -7 | — |
| SECONDARY βCTX (Carboxy Terminal Collagen Crosslinks), Osteocalcin, and Adiponectin. |
78.7; -0.6; -9.2; 0.2; 3.6; -5 | — |
| SECONDARY Bone Mineral Density |
-4; -2.6; -1.1; 1.9 | — |
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.
Eligibility 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 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.
Data sourced from ClinicalTrials.gov (NCT00927355). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.