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Could a common diabetes drug weaken your bones?

NCT ID NCT00467285

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

96 people

The number who actually took part.

Start date

Oct 2006

Finished

Sep 2009

Lead sponsor

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

30 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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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