Effect of Thiazolidinediones on Human Bone - Full Text View

Sponsor:	Emory University
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00927355

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:

MedlinePlus related topics: Bone Density Minerals

Drug Information available for: Pioglitazone Pioglitazone hydrochloride

U.S. FDA Resources

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 ]

Estimated Enrollment:	12
Study Start Date:	April 2009
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	August 2009 (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: Pioglitazine Placebo
Placebo Comparator: Placebo The other half will be randomized to placebo.	Drug: Pioglitazone or placebo 6 month treatment with placebo or pioglitazone Other Names: Pioglitazine Placebo

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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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927355

Contacts

Contact: Natasha B Khazai, M.D.	404-778-1678	nkhazai@emory.edu
Contact: Guillermo Umpierrez, M.D.	404-778-1665	geumpie@emory.edu

Locations

United States, Georgia
Grady Diabetes Clinic	Recruiting
Atlanta, Georgia, United States, 30303
Contact: Guillermo Umpierrez, M.D. 404-778-1665 geumpie@emory.edu
Principal Investigator: Natasha B Khazai, M.D.
Sub-Investigator: Guillermo Umpierrez, M.D.

Sponsors and Collaborators

Emory University

Investigators

Principal Investigator:

Natasha B Khazai, M.D.

Emory University

More Information

No publications provided

Responsible Party:	Natasha Khazai, Emory university
ClinicalTrials.gov Identifier:	NCT00927355 History of Changes
Other Study ID Numbers:	08006
Study First Received:	June 24, 2009
Last Updated:	June 24, 2009
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 February 09, 2012