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Could an osteoporosis drug shield the pancreas in type 1 diabetes?

NCT ID NCT06524960

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This trial tests whether denosumab, a drug already used for bone conditions, can protect the beta cells that produce insulin in people with early type 1 diabetes. Researchers believe the same biological pathway that denosumab targets in bones may also help preserve beta cell function. The study will compare denosumab against a placebo in 45 adults to see if it safely improves blood sugar control and insulin production.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
denosumab, a drug approved for osteoporosis, repurposed to protect beta cells in type 1 diabetes
What this could lead to
If it works, denosumab could slow the progression of type 1 diabetes by preserving the body's ability to make insulin.
What could go wrong
This is an early-phase trial with only 45 participants, so results may not apply broadly. Denosumab also carries risks like low calcium and bone infections.

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.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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.

Main Inclusion Criteria * Age: Females 18-50 years; males 21-50 years (minimum age based on skeletal maturity) * Diagnosis of type 1 diabetes (T1D) based on ADA Criteria: * Hyperglycemia (glycosylated hemoglobin (HbA1c) ≥ 6.5%; OR * fasting plasma glucose ≥ 126 mg/dl (7.0 mmol/L); OR * 2-hour plasma glucose ≥ 200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test; OR * In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥ 200 mg/dl (11.1 mmol/L) * Documented history of at least one type 1 diabetes associated autoantibody * GAD specific autoantibodies (GADA); * Islet-antigen 2 specific autoantibody (IA-2A); and/or * Zinc Transporter 8 specific autoantibody (ZNT8A) * Time from T1D diagnosis to screening MMTT must be ≥ 12 months but ≤ 5 years * Non-fasting C-peptide concentrations of at least 0.2 nmol/L (0.6 ng/ml) at pre-screening and confirmed during a MMTT done at screening visit. * Serum calcium (corrected for albumin)\* within normal limits per site's local lab * Agreement by women of childbearing potential (WOCBP) and males of childbearing potential to use a highly effective method of birth control for the course of the study through at least 5 months from the last dose of protocol therapy Main Exclusion Criteria * History of delayed puberty unless there is radiologic evidence of skeletal maturity * Use of other investigational agents within 3 months of enrollment * Vitamin D3 deficiency (\< 30 ng/ml) * History of anorexia and/or eating disorder * BMI \> 32 kg/m2 * HbA1c \> 9.5% * Severe hypoglycemia or diabetic ketoacidosis (DKA) within 3 months prior to screening. Subjects who had such episodes within 3-6 months prior to screening, must have written clearance from their treating physician. * Use of any of the diabetes medications other than insulin within 3 months of enrollment (e.g., metformin, sulfonylurea, GLP-1 agonists, DPP4 inhibitors, Symlin, SGLT2-inhibitors, amylin) * Treatment with any of the following drugs in past year: immunosuppressants, anticonvulsant therapy, adrenal or anabolic steroids, calcitonin, selective estrogen receptor modulator, sodium fluoride (other than dental treatment), teriparatide, abaloparatide, strontium or aromatase inhibitors; any history of bisphosphonate treatment. * Bone fractures (excluding skull, facial bones, metacarpals, fingers, toes and spontaneous fractures associated with severe trauma) within the past 12 months * Disorders associated with altered skeletal structure or function (Paget's disease, chronic liver disease (liver enzymes \> twice the upper limit of normal), malignancy, hypoparathyroidism or hyperparathyroidism, acromegaly, Cushing's syndrome, hypopituitarism, chronic obstructive pulmonary disease, alcohol intake \> 3 units/day) * Significant dental/oral disease, including prior history or current evidence of osteonecrosis/osteomyelitis of the jaw, active dental or jaw condition requiring oral surgery, non-healed dental/oral surgery, or planned invasive dental procedures for the course of the study * Pregnancy or actively breastfeeding (within 6 months prior to screening), or planning to become pregnant with 5 months after last dose of protocol therapy

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • City of Hope Medical Center

    RECRUITING

    Duarte, California, 91010, United States

  • Indiana University

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35233, United States

More trials for these conditions

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