Study on Treating Adynamic Bone Disorder with Teriparatide in Patients with Chronic Kidney Disease

1 1 1 1

What is this study about?

This clinical trial is focused on studying the treatment of adynamic bone disorder in patients who have chronic kidney disease. The treatment being tested is a medication called teriparatide, which is given as a solution for injection under the skin. The main goal of the study is to see if 18 months of treatment with teriparatide can improve bone health better than no treatment at all in these patients.

Participants in the study will receive either the teriparatide treatment or no treatment, which is sometimes referred to as a placebo. The study will last for 18 months, during which time various aspects of bone health will be monitored. This includes looking at changes in bone density, which is a measure of how strong the bones are, and checking for any fractures that might occur. The study will also examine other factors related to bone health, such as bone structure and the levels of certain substances in the blood that are important for bone health.

Throughout the study, researchers will collect information to understand how teriparatide affects bone metabolism, which is the process by which bones are formed and broken down. The study aims to provide valuable insights into whether teriparatide can be an effective treatment for improving bone health in patients with chronic kidney disease and adynamic bone disorder. Participants will be closely monitored to ensure their safety and to gather comprehensive data on the effects of the treatment.

1 initial assessment

Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes reviewing medical history and conducting necessary tests to ensure the criteria for participation are met.

2 baseline measurements

Baseline measurements will be taken to establish a starting point for the study. This includes bone density scans and blood tests to measure various markers related to bone health.

3 treatment phase

During the treatment phase, the medication teriparatide will be administered. This involves a subcutaneous injection, which means the medication is injected under the skin. The dosage and frequency will be determined by the study protocol and communicated to you by the study team.

The treatment will last for 18 months, during which regular monitoring and follow-up visits will be scheduled to assess progress and any side effects.

4 follow-up assessments

Throughout the study, follow-up assessments will be conducted at specified intervals. These assessments will include bone density scans, blood tests, and other evaluations to monitor changes in bone health and overall well-being.

The study team will provide detailed instructions on when and where these assessments will take place.

5 final evaluation

At the end of the 18-month treatment period, a final evaluation will be conducted. This will involve comprehensive testing to compare the initial and final results, assessing the impact of the treatment on bone health.

The study team will discuss the findings with you and provide any necessary follow-up care or recommendations.

Who Can Join the Study?

Must be 18 years or older.
Must have chronic kidney disease at stage 4 or 5D. This means the kidneys are not working well, with an estimated glomerular filtration rate (eGFR) of 29 ml/min or less.
Must have a DEXA scan showing a T-score or Z-score of -2 or less at the hip, femoral neck, or lumbar spine. A DEXA scan is a test that measures bone density. If taking prednisolone (a type of steroid medication) at 5 mg/day or more for at least 3 months, the score should be less than -1. Alternatively, must have had a previous bone fracture from a minor injury, confirmed by a special x-ray or scan.
Must have signs of adynamic bone disorder, which can be shown by a blood test with a BSAP level of 21 µg/l or less or a biopsy showing low bone activity.

Who Cannot Join the Study?

Patients with a condition called adynamic bone disorder cannot participate. This is a bone condition where the bones do not form or break down properly.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Both male and female patients are eligible, but if you do not identify as either, you may not be able to participate.
Patients who are considered part of a vulnerable population, which means they might need special protection or care, are not included in this study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Aalborg University Hospital	Aalborg	Denmark
Odense University Hospital	Odense	Denmark
Hignqj Huyerbuc	Herlev	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.03.2021

Trial locations

Investigated drugs:

Teriparatide

Teriparatide is a medication used in this clinical trial to help improve bone health. It is a form of parathyroid hormone, which is naturally found in the body and plays a crucial role in regulating calcium levels and bone metabolism. In this trial, teriparatide is being tested to see if it can help patients with chronic kidney disease and a specific bone condition called adynamic bone disorder. The goal is to determine if using teriparatide for 18 months can improve bone metabolism better than not using any treatment at all. This medication is given to help stimulate bone growth and increase bone strength, which may be beneficial for patients with weakened bones due to their condition.

Adynamic bone disorder – Adynamic bone disorder is a condition characterized by a significant reduction in bone turnover, which means that the normal process of bone renewal and repair is slowed down. This disorder often occurs in individuals with chronic kidney disease, where the bones become less responsive to the hormones that regulate bone metabolism. As a result, the bones may become weaker and more prone to fractures. The condition is marked by low levels of bone formation and resorption, leading to a decrease in bone density. Over time, this can affect the structural integrity of the bones, making them more susceptible to damage. The progression of adynamic bone disorder can vary, but it generally involves a gradual decline in bone health.

Trial ID:

2023-506853-39-00

Protocol code:

20192022

NCT ID:

NCT04522622

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Treating Adynamic Bone Disorder with Teriparatide in Patients with Chronic Kidney Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?