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Diabetes drug may also protect bones, early trial hints

NCT ID NCT06050577

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 21, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether oral semaglutide (Rybelsus), a drug already used for type 2 diabetes, can improve bone health in people aged 50-85 with diabetes and weak bones (osteopenia). Over 52 weeks, 64 participants will receive either the drug or a placebo. Researchers will measure bone formation and breakdown markers, bone density, and bone strength to see if the drug shifts the balance toward stronger bones.

What this could mean

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

Active substance
oral semaglutide (Rybelsus)
What this could lead to
If it works, this could point toward a treatment that helps people with type 2 diabetes maintain stronger bones and reduce fracture risk.
What could go wrong
This is a small, early-phase trial with only 64 participants. The results may not apply to everyone, and the bone benefits might be too small to matter in practice.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 64 people

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

Started

Jun 2024

Expected to finish

Mar 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

50 to 85 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.

Inclusion criteria * Type 2 diabetes and glycosylated haemoglobin (HbA1C) of 48-91 mmol/mol (6.5-10.5%) and * T-score \<-1 in hip or lower back, assessed by DXA scan and / or * Low-energy fracture within the last 3 years Exclusion criteria * T-score \<-2.5 in hip or lower back, assessed by DXA scan, although these individuals may be included if they are not candidates for conventional osteoporosis therapy, e.g., due to allergies and renal impairment, or if they prefer to participate in the trial. * Type 1 diabetes mellitus * Severe NPDR (non-proliferative diabetic retinopathy) or PDR (proliferative diabetic retinopathy) assessed within the last year. If a recent assessment is unavailable, a new retinal photo test will be performed. * Congestive heart failure (NYHA Class IV) * Primary hyperparathyroidism * Vitamin D deficiency (\<25 nM) (re-test after substitution acceptable) * Known disorders affecting bone metabolism, e.g., uncontrolled thyrotoxicosis, severe renal impairment (eGFR \<30) or liver dysfunction (baseline phosphatase higher than twice upper limit (105 U/L)), rheumatism, celiac disease, hypogonadism, severe COPD, hypopituitarism, Cushing's disease * Clinically significant concomitant diseases or disorders (e.g., cancer) or clinically significant abnormal values in laboratory screening tests, including increased Choriogonadotropin (hCG) in women. * History of gastrointestinal surgery (except uncomplicated surgical procedures such as hernia surgery and appendectomy) * Antiresorptive or bone anabolic drugs for the last 12 months * Use of anabolic steroids in the previous year * Use of GLP-1Ras within 90 days * Stable therapy with DPP4 inhibitors (unless the patient is willing to discontinue the treatment) * History of pancreatitis * Allergy or hypersensitivity to the active substance or to any of the ingredients * Inability to give informed consent * Previous bariatric surgery * BMI \<20 kg/m2 or BMI\>37 kg/m2

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Conditions

The condition(s) this trial relates to.

Bone Diseases, Metabolic type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Odense University Hospital

    Odense, 5000, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.