Study on Zoledronic Acid Following Denosumab for Osteoporosis Patients

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What is this study about?

This clinical trial is focused on studying osteoporosis, a condition where bones become weak and are more likely to break. The study is examining the effects of a treatment called zoledronic acid, also known as zoledronate. This medication is given as a solution through an intravenous (IV) infusion, which means it is delivered directly into the bloodstream through a vein. The trial will also use a 100 mL isotonic saline solution, which is a standard fluid used in medical treatments.

The purpose of the study is to explore whether multiple infusions of zoledronic acid can help prevent bone loss in patients who have previously been treated with another medication called denosumab. The study will look at how effective zoledronic acid is when given at different times after stopping denosumab. It will also investigate if yearly infusions of zoledronic acid can prevent bone loss after the initial treatment period. Additionally, the study will examine how stopping denosumab affects muscle mass, muscle strength, and insulin sensitivity, which is how the body processes sugar.

Participants in the study will receive treatments over a period of time, and their bone health will be monitored through various tests. These tests will include measuring bone density, which is the strength of the bones, and looking at specific markers in the blood that indicate bone activity. The study aims to provide a better understanding of how to manage bone health in patients with osteoporosis who have been treated with denosumab.

1 initial visit

Upon joining the clinical trial, you will attend an initial visit. During this visit, your medical history will be reviewed, and you will undergo a physical examination. This is to ensure that you meet the eligibility criteria for the study.

2 baseline assessments

You will undergo a series of baseline assessments. These include a bone density scan, known as a DXA scan, to evaluate your bone health. Blood samples will be collected to measure various biochemical markers related to bone turnover and muscle health.

3 first infusion

You will receive your first infusion of zoledronate. This medication is administered through an intravenous (IV) infusion, which means it is given directly into your vein. The infusion contains 5 mg of zoledronate in 100 mL of isotonic saline. This process will take place at a healthcare facility.

4 follow-up visits

You will have follow-up visits at regular intervals. These visits will include additional bone density scans and blood tests to monitor your response to the treatment. The primary focus is to assess changes in your bone mineral density (BMD) at the lumbar spine, total hip, and femoral neck after 12 and 36 months.

5 yearly infusions

You will receive yearly infusions of zoledronate to help maintain bone health. These infusions will be similar to the first one and will be scheduled at specific intervals based on your treatment plan.

6 additional assessments

Throughout the trial, additional assessments will be conducted to evaluate changes in muscle mass and strength, as well as insulin sensitivity. These assessments will help understand the broader effects of the treatment on your overall health.

7 end of trial

At the end of the trial, a final evaluation will be conducted. This will include a comprehensive review of your bone health and any changes observed during the study. The results will contribute to understanding the effectiveness of the treatment.

Who Can Join the Study?

Must be a postmenopausal woman (a woman who has not had a menstrual period for at least two years).
Must be 40 years old or older.
Must have been treated with denosumab (a medication used to treat osteoporosis) for at least two years.
The last injection of denosumab must have been received less than five months ago.
Must have at least two lumbar vertebrae (bones in the lower spine) that can be evaluated by DXA (a type of scan that measures bone density).

Who Cannot Join the Study?

Patients who are male cannot participate. This study is only for females.
Patients who are part of a vulnerable population cannot participate. This means groups of people who might need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Aalborg University Hospital	Aalborg	Denmark
Region Midtjylland	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.02.2023

Trial locations

Investigated drugs:

Zoledronic Acid

Zoledronate is a medication used in this clinical trial to help manage bone health in patients who have previously been treated with another medication called denosumab. Zoledronate is given through an infusion, which means it is delivered directly into the bloodstream. The main goal of using zoledronate in this study is to prevent a rapid increase in bone turnover, which can lead to bone loss, after stopping denosumab treatment. The study is exploring whether giving zoledronate at specific times or when bone turnover increases can help maintain bone strength. Additionally, the trial is looking at whether yearly infusions of zoledronate can continue to protect against bone loss after the initial treatment period.

Denosumab is a medication that was used by patients before they entered this clinical trial. It is typically used to treat osteoporosis by slowing down the process that breaks down bone, helping to maintain bone density and strength. In this study, researchers are interested in understanding what happens to bone health after patients stop taking denosumab. They are also looking at how stopping denosumab affects muscle mass, muscle strength, and how the body processes insulin, which is important for managing blood sugar levels.

Investigated diseases:

Osteoporosis

Osteoporosis – Osteoporosis is a condition characterized by weakened bones, making them more prone to fractures. It occurs when the creation of new bone doesn’t keep up with the removal of old bone. As the disease progresses, bones become porous and fragile, often without any symptoms until a fracture occurs. Common fracture sites include the hip, spine, and wrist. The disease can lead to a decrease in height over time and a stooped posture. Bone density tests are often used to assess the progression of bone weakening.

Trial ID:

2022-502621-17-00

Protocol code:

01.12.2022

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Zoledronic Acid Following Denosumab for Osteoporosis Patients

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