Effect of Diabetic Medications on Bone Metabolism

This study has been terminated.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00467285
First received: April 26, 2007
Last updated: October 22, 2009
Last verified: October 2009
  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
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

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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.
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
Study Population

subjects with type 2 diabetes and less than 55 years with or without pioglitazone as part of their therapy for diabetes

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00467285

Locations
United States, Louisiana
Overton Brooks VA Medical Center, Shreveport
Shreveport, Louisiana, United States, 71101
Sponsors and Collaborators
Investigators
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:
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 July 22, 2014