Effect of Diabetic Medications on Bone Metabolism
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Purpose
Subjects with diabetes and pre-diabetes are said to have increased bone loss when compared to the general population. Pioglitazone a thiazolidinedione, is a Food and Drug Administration (FDA) approved oral anti-diabetic agent for the treatment of type 2 diabetes. Though there are many benefits for using thiazolidinediones in the treatment of type 2 diabetes, there is data that indicates that rosiglitazone therapy results in a significant decrease in total body bone mineral density in mice. Whether it is true in humans is not clear. If the animal data can be extrapolated to humans, thiazolidinediones may pose a significant risk of adverse effects on bone. This study hypothesizes that treatment with the thiazolidinedione pioglitazone may result in significant reduction in bone mineral density. The aims of this are: 1. to evaluate the effect of pioglitazone on skeletal health; 2. to measure the bone mineral density (BMD) of the spine and hip, as well as bone turnover markers, at different times of persons taking thiazolidinediones and others not taking them; 3. to determine the change in BMD and bone turnover markers within different groups at different times; and 4. to compare these changes.
| Condition |
|---|
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Osteoporosis Type 2 Diabetes Mellitus |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Effect of Thiazolidinediones on Skeletal Health |
- changes in BMD and bone turn over markers in subjects with diabetes on pioglitazone compared to those who are not on pioglitazone [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Urine and serum samples collected for the study will be spin and stored at -70 degree C and assays run intermittently
| Estimated Enrollment: | 280 |
| Study Start Date: | October 2006 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
140 subjects with type 2 diabetes on pioglitazone.
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|
2
140 subjects with type 2 diabetes not on pioglitazone.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 30 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
subjects with type 2 diabetes and less than 55 years with or without pioglitazone as part of their therapy for diabetes
Inclusion Criteria:
- Age 30-55 years
- Gender: men and women
- Ethnicity: all ethnic groups
- 140 subjects with diabetes and no pioglitazone (recently started i.e. less than 3 months as well as those who have just initiated pioglitazone treatment)
- 140 control subjects (subjects with diabetes and not on pioglitazone) will be included
- The control subjects will be chosen to match age, sex, ethnicity and comparable smoking and alcohol history
- To avoid confusion factor of vitamin D and calcium intake, all the subjects will be given vitamin D and calcium supplements (USDA recommended doses)
Exclusion Criteria:
- Patients who are unable or unwilling yo give informed consent
- Immobilized or bed bound subject
- Subjects wil known diseases associated with disordered bone metabolism such as chronic renal insufficiency, chronic steroid use, primary hyperparathyroidism, untreated subclinical or clinical hyperthyroidism and Paget's disease. To identify subjects with decreased Glomerular filtration rate (GFR) even if creatinine is normal will be excluded (at the proposed study site, routine bm includes calculated GFR from the chemistry lab)
- Patients on medications that will alter bone metabolism will be excluded. They are glucocorticoids, gonadal hormones (testosterone in men and estrogen in women).
- Subjects with known history of chronic pancreatitis, pancreatectomy or malabsorption syndromes to avoid confounding factors known to affect vitamin D metabolism and indirectly bone mineral metabolism.
- Female patients with perimenopause or menopause: history of hypogonadism (History of ovariectomy or postmenopausal women) to avoid bone turn over changes secondary to hypogonadism. Perimenopausal women identifies by screening FSH and LH and excluding women with elevated FSH be excluded to avoid perimenopausal effect on bone turnover (women over 35 will still have a screening gonadal hormonal evaluation).
Contacts and Locations| United States, Louisiana | |
| Overton Brooks VA Medical Center, Shreveport | |
| Shreveport, Louisiana, United States, 71101 | |
| Principal Investigator: | Subhashini Yaturu, MD | Overton Brooks VA Medical Center, Shreveport |
More Information
Publications:
| Responsible Party: | Yaturu, Subhashini - Principal Investigator, Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00467285 History of Changes |
| Other Study ID Numbers: | ENDB-019-06S |
| Study First Received: | April 26, 2007 |
| Last Updated: | October 22, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Bone Density C-telopeptide Dual-Energy X-Ray Absorptiometry N-telopeptide |
Osteocalcin Osteoporosis Thiazolidinediones Type 2 Diabetes Mellitus |
Additional relevant MeSH terms:
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Diabetes Mellitus Diabetes Mellitus, Type 2 Osteoporosis Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Bone Diseases, Metabolic |
Bone Diseases Musculoskeletal Diseases 2,4-thiazolidinedione Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013