Effect of Thiazolidinediones on Human Bone (NCT00927355) | Clinical Trial Compass
CompletedNot Applicable
Effect of Thiazolidinediones on Human Bone
United States10 participantsStarted 2009-04
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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