Could a common diabetes drug weaken your bones?
NCT ID NCT00467285
First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This study asks whether pioglitazone, a widely used diabetes medication, might reduce bone density in people with type 2 diabetes. Researchers will compare bone mineral density and bone turnover markers in adults aged 30-55 who take pioglitazone versus those who do not. The goal is to see if the drug poses a risk to skeletal health, which could influence future treatment decisions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pioglitazone, an oral diabetes medication
- What this could lead to
- If it works, this could clarify whether pioglitazone poses a bone risk, guiding safer diabetes treatment choices.
- What could go wrong
- This is a small, early-stage observational comparison, so results may not be conclusive or apply to all patients. Bone density changes, if any, may be modest.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
-
96 people
The number who actually took part.
- Start date
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Oct 2006
- Finished
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Sep 2009
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
subjects with type 2 diabetes and less than 55 years with or without pioglitazone as part of their therapy for diabetes
- Ages
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30 to 55 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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