Diabetes drug may also protect bones, early trial hints
NCT ID NCT06050577
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 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 * 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.
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
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