Study on Dasatinib and Quercetin for Patients with Osteoporosis or Osteopenia

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What is this study about?

This clinical trial is focused on studying the effects of a treatment on individuals with osteopenia and osteoporosis, which are conditions characterized by low bone mass and increased risk of fractures. The treatment being tested includes a combination of dasatinib, a medication known as a protein kinase inhibitor, and either quercetin or nicotinamide riboside. These substances are being investigated for their potential to improve bone health by reducing bone resorption, which is the process where bone is broken down and its minerals are released into the bloodstream.

The purpose of the study is to evaluate the effectiveness and safety of this treatment in reducing bone resorption in patients with low bone mass. Participants in the study will receive either the treatment or a placebo. The study will last for a period of 21 weeks, during which time various markers of bone health will be monitored. These markers include CTX, a circulating marker of bone resorption, as well as other markers related to bone formation and resorption.

Throughout the study, participants will be monitored to assess changes in these markers, which will help determine the impact of the treatment on bone health. The study aims to provide valuable insights into whether this combination of medications can offer a new approach to managing conditions like osteopenia and osteoporosis, potentially leading to improved therapies for individuals affected by these conditions.

1 joining the trial

Upon joining the trial, eligibility is confirmed based on specific criteria such as age, bone health status, and ability to provide informed consent.

Participants are required to be between 60-90 years old and have a diagnosis of osteopenia or osteoporosis.

2 initial assessment

An initial assessment is conducted to evaluate bone health and risk of fractures. This may include bone density scans and blood tests.

The assessment helps in understanding the current state of bone resorption and formation markers.

3 medication administration

Participants receive the medication dasatinib orally. The dosage and frequency are determined by the study protocol.

The medication is taken for a specified duration as part of the trial to assess its effects on bone health.

4 ongoing monitoring

Regular monitoring is conducted throughout the trial to track changes in bone resorption and formation markers.

Participants may undergo periodic blood tests and other assessments to measure the impact of the medication.

5 final assessment

At the end of the trial period, a final assessment is conducted to evaluate the changes in bone health.

The primary focus is on the change in circulating markers of bone resorption at 21 weeks.

6 completion of trial

Upon completion of the trial, participants may receive information about the overall findings and any potential next steps.

The trial is estimated to conclude by May 31, 2025.

Who Can Join the Study?

Men and women aged 60-90 years. For women, they should be more than 5 years past menopause, which is confirmed by specific hormone levels (FSH and LH).
Have an increased risk of fractures as determined by the WHO’s 10-year Fracture Risk Assessment Tool (FRAX).
Have osteopenia or osteoporosis based on specific bone density scores (T-scores):
- Osteopenia with a T-score between -2 and -2.5 at the hip, femoral neck, or spine, with a FRAX score between 10-70.
- Osteopenia with a T-score between -1 and -2.5 and a history of a fragility fracture (except hip and vertebral fractures in the last 2 years), with a FRAX score between 11-68.
- Osteoporosis with a T-score between -3 and -2.5, suitable for conventional osteoporosis treatments but choosing to participate in the trial, or unable to use conventional treatments due to medical reasons.
Ability to understand the study and provide informed consent, which means agreeing to participate after being fully informed about the study.

Who Cannot Join the Study?

Patients with conditions other than osteopenia or osteoporosis cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are part of a vulnerable population cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Odense University Hospital	Odense	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.03.2023

Trial locations

Investigated drugs:

Dasatinib

Dasatinib is a medication that is typically used to treat certain types of cancer. In this trial, it is being studied for its potential to help improve bone health in people with low bone mass. Researchers are interested in seeing if dasatinib can help reduce the breakdown of bone, which is a common problem in conditions like osteoporosis.

Quercetin is a natural substance found in many fruits and vegetables. It is being tested in this trial to see if it can work together with dasatinib to help protect bones. Quercetin is thought to have properties that might help reduce inflammation and support bone health.

Nicotinamide Riboside is a form of vitamin B3 that is being studied for its potential benefits on bone health. In this trial, researchers are exploring whether nicotinamide riboside can help improve bone strength and reduce bone loss in people with low bone mass. It is believed to support the health of cells, which might be beneficial for maintaining strong bones.

Investigated diseases:

Osteopenia – Osteopenia is a condition characterized by lower than normal bone mineral density, which is not as severe as osteoporosis. It occurs when the creation of new bone doesn’t keep up with the removal of old bone. Over time, this imbalance leads to bones becoming weaker and more fragile. Individuals with osteopenia may not experience any symptoms, but the condition can be detected through bone density tests. As the condition progresses, it can increase the risk of fractures. Osteopenia serves as a warning sign for potential development into osteoporosis if bone loss continues.

Osteoporosis – Osteoporosis is a disease where decreased bone strength increases the risk of a broken bone. It is characterized by a reduction in bone mass and deterioration of bone tissue, leading to fragile and brittle bones. This condition often progresses silently over many years, with no symptoms until a fracture occurs. Common fracture sites include the hip, spine, and wrist. The disease is more common in older adults, particularly postmenopausal women, due to hormonal changes that affect bone density. As osteoporosis advances, even minor stresses like bending over or coughing can cause fractures.

Trial ID:

2022-502076-23-00

NCT ID:

NCT06018467

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Dasatinib and Quercetin for Patients with Osteoporosis or Osteopenia

What is this study about?

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