Effect of Thiazolidinediones on Human Bone
This study has been completed.
Sponsor:
Emory University
Information provided by (Responsible Party):
Natasha Khazai, M.D., Emory University
ClinicalTrials.gov Identifier:
NCT00927355
First received: June 24, 2009
Last updated: June 6, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Osteoblast Adipocytes Bone Density Osteocalcin Adiponectin Mesenchymal Stem Cells |
Drug: Pioglitazone or placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) |
| Official Title: | Effects of Thiazolidinediones on Human Bone Marrow Stromal Cell Differentiation Capacity:In Vitro and In Vivo- A Pilot Study |
Resource links provided by NLM:
Further study details as provided by Emory University:
Primary Outcome Measures:
- adipocyte and osteoblast colony forming units cultured from bone marrow stem cells [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- CTX, P1NP, osteocalcin, leptin and adiponectin. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Bone mineral density [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 10 |
| Study Start Date: | April 2009 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Pioglitazone
half of the diabetic patients will be randomized to pioglitazone treatment for 6 months.
|
Drug: Pioglitazone or placebo
6 month treatment with placebo or pioglitazone
Other Names:
|
|
Placebo Comparator: Placebo
The other half will be randomized to placebo.
|
Drug: Pioglitazone or placebo
6 month treatment with placebo or pioglitazone
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided by Emory University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Natasha Khazai, M.D., assistant professor, Emory University |
| ClinicalTrials.gov Identifier: | NCT00927355 History of Changes |
| Other Study ID Numbers: | 08006 |
| Study First Received: | June 24, 2009 |
| Last Updated: | June 6, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Emory University:
|
pioglitazone human bone marrow stem cells adipocytes osteoblasts bone mineral density |
adiponectin leptin CTX P1NP Osteocalcin |
Additional relevant MeSH terms:
|
Pioglitazone 2,4-thiazolidinedione Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013