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Study on the Effects of Oral Semaglutide on Bone Health in Patients with Type 2 Diabetes and Low Bone Mass

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called semaglutide on bone health in people with Type 2 diabetes. Type 2 diabetes is a condition where the body struggles to regulate blood sugar levels. The trial aims to see if semaglutide, which is taken as a tablet, can help improve bone formation and strength in individuals with this condition who also have low bone mass. Low bone mass can make bones weaker and more prone to fractures.

Participants in the study will be randomly assigned to receive either semaglutide or a placebo, which looks like the medication but does not contain the active ingredient. The study will last for about a year, during which time participants will take the tablets and have regular check-ups to monitor their bone health and overall well-being. The main focus will be on changes in bone formation markers, which are substances in the body that indicate how well bones are being formed.

Throughout the study, various assessments will be conducted to measure changes in bone strength, bone density, and other related factors. These assessments will help researchers understand if semaglutide can positively impact bone health in people with Type 2 diabetes. The study will also look at changes in body composition, such as fat and muscle distribution, and other health indicators like blood sugar levels and physical activity. The findings from this trial could provide valuable insights into managing bone health in individuals with Type 2 diabetes.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participation is confirmed based on specific criteria related to type 2 diabetes and bone health.
Eligibility is determined by factors such as blood sugar levels and bone density measurements.
Step 2
Initial assessment
An initial assessment is conducted to establish baseline health data.
This includes a DXA scan to measure bone density and other health evaluations.
Step 3
Medication administration
Participants receive either semaglutide or a placebo in the form of an oral coated tablet.
The medication is taken as prescribed, with the dosage and frequency determined by the study protocol.
Step 4
Ongoing monitoring
Regular monitoring occurs throughout the study to track changes in health markers.
This includes assessments of bone formation, strength, and other related health indicators.
Step 5
Final assessment
After 52 weeks, a final assessment is conducted to evaluate the effects of the medication.
The primary focus is on changes in bone formation markers and overall bone health.
Step 6
Completion of study
The study concludes with a review of all collected data to determine the impact of the treatment.
Participants are informed of the study's findings and any relevant health information.

Who can join the trial?

6 criteria

Must have **Type 2 diabetes**. This is a condition where the body has trouble using sugar properly.
**Glycosylated haemoglobin (HbA1C)** levels should be between 48-91 mmol/mol (6.5-10.5%). HbA1C is a blood test that shows average blood sugar levels over the past 2-3 months.
**T-score** must be less than -1 in the hip or lower back. This is measured by a **DXA scan**, which is a special X-ray that checks bone strength.
Must have had a **low-energy fracture** in the last 3 years. This means a bone break that happened from a minor fall or accident.
Open to both **men and women**.
Participants should be adults, as the age range includes categories for adults.

Who cannot join the trial?

5 criteria

Patients who do not have Type 2 diabetes cannot participate. Type 2 diabetes is a condition where the body does not use insulin properly, leading to high blood sugar levels.
Patients with normal bone mass cannot participate. Low bone mass means the bones are weaker than normal, which can increase the risk of fractures.
Patients who are not within the specified age range cannot participate. The trial is open to certain age groups only.
Patients who are not male or female cannot participate. The trial is open to both men and women.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may need special protection, like children or the elderly.

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Odense University Hospital
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Odense, Denmark

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Investigated drugs

Semaglutide is a medication used in this clinical trial to see if it can help improve bone formation and strength in people with type 2 diabetes who also have low bone mass. It is a long-acting GLP-1 receptor agonist, which means it works by mimicking a hormone in the body that helps regulate blood sugar levels. The trial is investigating whether this medication can also have positive effects on bone health.

What is already known about the treatment

Semaglutide – This medication is administered orally and is currently being studied in clinical trials for its effects on bone health in patients with type 2 diabetes. It is a long-acting GLP-1 receptor agonist, which is a class of drugs used to manage blood sugar levels. Semaglutide works by mimicking the action of a natural hormone that stimulates insulin release and reduces appetite. The main therapeutic indication for semaglutide is the treatment of type 2 diabetes, and it is being explored for its potential benefits in improving bone formation and strength.

Investigated diseases

Type 2 Diabetes – Type 2 diabetes is a chronic condition that affects the way the body processes blood sugar (glucose). It is characterized by insulin resistance, where the body's cells do not respond properly to insulin, and eventually, the pancreas may not produce enough insulin. Over time, high blood sugar levels can lead to various complications, including damage to the eyes, kidneys, nerves, and heart. The disease often develops gradually and is more common in adults, although it is increasingly seen in younger individuals due to rising obesity rates. Symptoms may include increased thirst, frequent urination, hunger, fatigue, and blurred vision. Managing blood sugar levels is crucial to prevent complications associated with this condition.