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Study on the Effects of Alendronate on Bone and Blood Sugar Markers in Patients with Diabetes and Osteopenia/Osteoporosis

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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 treatment on patients with Diabetes Mellitus, which includes both type 1 and type 2 diabetes, and conditions related to bone health such as osteopenia and osteoporosis. The treatment being tested is a medication called Alendronate, which is commonly used to strengthen bones. The study will also involve a comparison with a placebo, which is a substance with no active medication.

The purpose of the study is to investigate how Alendronate affects markers related to bone health and blood sugar control in patients with diabetes. Participants will take the medication in the form of tablets, and the study will monitor changes in their bone and blood sugar markers over time. The study will last for a period of up to 24 months, during which participants will have regular check-ups to assess their health and the effects of the treatment.

Throughout the study, various health indicators will be measured, including HbA1c (a marker of blood sugar levels), bone density, and other substances in the blood that can provide information about bone and metabolic health. The study aims to provide insights into how Alendronate can benefit patients with diabetes who also have concerns about their bone health.

The research process

The trial runs in 5 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, eligibility is confirmed based on criteria such as having type 1 or type 2 diabetes, being 50 years or older, maintaining consistent diabetes treatment for the past six months, and having a specific range of HbA1c levels and body mass index (BMI).
Step 2
Initial assessment
An initial assessment is conducted to evaluate bone density and glycemic markers. This includes measuring HbA1c levels and bone mineral density (BMD) using a DXA scan.
Step 3
Medication administration
Participants receive either Alendronate Teva 70 mg tablets or a placebo. The medication is taken orally once a week. The duration of this treatment phase is not specified but is part of the ongoing study until its estimated end date.
Step 4
Ongoing monitoring
Throughout the study, regular monitoring of various health markers is conducted. This includes insulin levels, plasma glucose, and other biochemical markers related to bone and metabolic health. Lifestyle factors such as diet and physical activity are also assessed.
Step 5
Final assessment
At the conclusion of the study, a final assessment is performed to evaluate changes in bone and glycemic markers. This includes repeating tests such as the DXA scan and measuring HbA1c levels.

Who can join the trial?

8 criteria

Must have **Type 1** or **Type 2 diabetes**.
Must be **50 years old or older**.
Must have been on the **same diabetes treatment** for the last six months, although changes in dose are allowed.
Must have had **HbA1c** (a measure of blood sugar levels over time) changes of **± 1** in the last six months.
Must have an **HbA1c level of 6.7% or higher** in the last six months.
Must have a **Body Mass Index (BMI)** between **19 and 35**. BMI is a measure of body fat based on height and weight.
Must have a **DXA T-score** between **-3.5 and -0.5**. This score is used to measure bone density.
Both **men and women** can participate.

Who cannot join the trial?

7 criteria

Patients who are pregnant or breastfeeding cannot participate.
Individuals with severe kidney problems are not eligible.
People with a history of allergic reactions to the study medication cannot join.
Participants who have taken similar medications recently are excluded.
Those with certain other medical conditions that might interfere with the study are not allowed.
Individuals who are unable to follow the study procedures cannot participate.
Patients currently participating in another clinical trial are not eligible.

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Verified sites

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Aalborg University Hospital
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Aalborg, Denmark

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Investigated drugs

Alendronate is a medication used in this clinical trial to study its effects on bone health and blood sugar levels in patients with type 1 and type 2 diabetes. It is commonly used to treat and prevent bone loss by slowing down the process that breaks down bone tissue, which can help maintain or increase bone density. In this trial, researchers are examining how Alendronate might influence markers related to bone health and how it might affect blood sugar control in diabetic patients.

Alendronate Sodium Monohydrate

What is already known about the treatment

Alendronate – Alendronate is typically administered orally in the form of tablets. It is a well-established medication in the treatment of bone-related conditions and is widely referenced in medical literature. The main therapeutic indications for Alendronate include the treatment and prevention of osteoporosis and osteopenia, particularly in patients with diabetes mellitus. At the molecular level, Alendronate works by inhibiting osteoclast-mediated bone resorption, which helps to maintain or increase bone density. It is classified pharmacologically as a bisphosphonate, a group of drugs known for their ability to strengthen bones and reduce the risk of fractures.

Investigated diseases

Diabetes Mellitus
A chronic condition characterized by high levels of sugar in the blood due to the body's inability to produce or effectively use insulin. Over time, high blood sugar levels can lead to damage in various organs and systems, particularly the nerves and blood vessels. The disease is categorized mainly into Type 1, where the body fails to produce insulin, and Type 2, where the body becomes resistant to insulin. Symptoms often include increased thirst, frequent urination, and unexplained weight loss. Management focuses on maintaining normal blood sugar levels through diet, exercise, and medication.
Osteopenia
A condition where bone mineral density is lower than normal, which can be a precursor to osteoporosis. It indicates that bones are weaker than they should be, but not to the extent of osteoporosis. Osteopenia does not usually cause symptoms, but it can increase the risk of fractures. It is often detected through bone density tests. Lifestyle changes and monitoring are typically recommended to prevent progression to osteoporosis.
Osteoporosis
A disease characterized by decreased bone density and increased fragility, leading to a higher risk of fractures. It often progresses silently without symptoms until a fracture occurs, typically in the hip, spine, or wrist. The condition is more common in older adults, especially postmenopausal women, due to hormonal changes that affect bone density. Prevention and management focus on maintaining bone health through diet, exercise, and sometimes medication. Regular bone density tests are used to monitor the condition.