Oral Semaglutide's effect on bone health in older adults with Type 2 Diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the impact of oral Semaglutide, a GLP-1 receptor agonist, on bone turnover in patients aged 50-85 years with Type 2 Diabetes and an increased risk of fractures. Participants will receive either Semaglutide or a placebo daily for 52 weeks. The study will assess changes in bone health through blood markers, bone scans, and direct measurements of bone strength. The goal is to determine if Semaglutide can improve bone density and reduce fracture risk in this population.

Why it matters

Who can join: the full rules

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

Where it's running

• Odense University Hospital
  Odense, Denmark Recruiting

Study contacts

• Study coordinator: Julie Bjerrelund, MD
• Email: julie.bjerrelund@rsyd.dk
• Phone: +4529849154

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Acute Blood Flow Restriction Walking in Type 2 Diabetes

  This study tests whether adding blood flow restriction to treadmill walking affects immune cells in adults with type 2 diabetes.

  Recruiting University of British Columbia · Kelowna, British Columbia · NCT07928531

• Continuous Glucose Monitoring in Type 2 Diabetes Not on Insulin

  This study tests whether using a continuous glucose monitoring system helps people with type 2 diabetes who aren’t using insulin to improve blood sugar control and quality of life.

  Recruiting Medical University of Bialystok · Bialystok · NCT07919236

• Differentiating heart disease in autoimmune vs. type 2 diabetes

  This study tests whether adult-onset autoimmune diabetes (AID/LADA) and type 2 diabetes (T2D) differ in how diabetic heart disease develops, using advanced heart imaging in people with AID, T2D, and healthy controls.

  Recruiting University of Roma La Sapienza · Rome, Roma · NCT07911007

• Lifestyle Metabotype Study B: Understanding Personalized Glucose Responses

  This study tests how lifestyle, metabolism, and brain energy use relate to each person’s blood sugar response after meals, across people with and without prediabetes or type 2 diabetes.

  Recruiting at 2 sites German Institute of Human Nutrition · Berlin and 1 other locations · NCT07888257

• Lifestyle Metabotype Study: How Daily Habits Shape Blood Sugar

  This observational study tests whether personal lifestyle and biological factors can predict how a person’s blood sugar responds after meals.

  Recruiting German Institute of Human Nutrition · Potsdam, Potsdam-Rehbrücke · NCT07868601

• Switching to Zenagamtide From Tirzepatide in Adults With Overweight or Obesity With or Without Type 2 Diabetes

  This study tests whether adults who are overweight or have obesity (with or without type 2 diabetes) can switch from tirzepatide to a new treatment called zenagamtide to find a tolerable dose.

  Recruiting at 2 sites Phase 1 Novo Nordisk A/S · Glendale, California and 1 other locations · NCT07868354

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.