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Effect of Diabetic Medications on Bone Metabolism

StatusCompleted
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Lead sponsor: US Department of Veterans Affairs to VA Office of Research and Developmentv10
  2. Results first posted: Jan 14, 2015 Primary endpoints: 1 to 4 · Enrollment target: estimated 280 to confirmed 96 · Secondary endpoints expanded, about 8 wordsv9 Show all 4 changesShow less
    • Primary endpoints: 1 to 4
    • Enrollment target: estimated 280 to confirmed 96
    • Secondary endpoints expanded, about 8 words

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Terminated to Completed Study sites: 1 to 0 · Publications: 7 to 2v8 Show all 3 changesShow less
    • Study sites: 1 to 0
    • Publications: 7 to 2

    See this version in full on ClinicalTrials.gov ↗

  4. Re-verified, no change to tracked fieldsv7
  5. Trial status: Recruiting to Terminated Site details revised · Publications reorderedv6 Show all 3 changesShow less
    • Site details revised
    • Publications reordered
Show 4 earlier versionsHide 4 earlier versions
  1. Publications reorderedv5
  2. Site contact updated Publications reorderedv4 Show all 2 changesShow less
    • Publications reordered
  3. Study description revised Publications reorderedv3 Show all 2 changesShow less
    • Publications reordered

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Sep 2009 · Completion date: Mar 2008 to Sep 2009 · Eligibility criteria revised · 3 morev2 Show all 7 changesShow less
    • Primary completion date: Sep 2009
    • Completion date: Mar 2008 to Sep 2009
    • Eligibility criteria revised
    • Study site revised
    • Publications: details revised at 1 of 7 entries
    • Study description expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00467285
Lead Sponsor VA Office of Research and Development
Conditions Osteoporosis, Type 2 Diabetes Mellitus
Enrollment 96 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov