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Study on Dasatinib and Quercetin or Nicotinamide Riboside for Patients with Osteoporosis or Osteopenia

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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 for people with osteoporosis and osteopenia, which are conditions that cause bones to become weak and more likely to break. The treatment being tested includes a medication called dasatinib, which is taken as a film-coated tablet. Dasatinib is known as a protein kinase inhibitor, which means it works by blocking certain proteins that can affect cell growth. In this study, dasatinib is combined with either quercetin or nicotinamide riboside, which are substances that may help improve bone health.

The purpose of this study is to investigate how effective and safe this combination treatment is in reducing bone loss in patients with low bone mass. Participants in the study will be randomly assigned to receive either the treatment or a placebo. The study will last for a period of 20 weeks, during which time participants will take the medication orally. Throughout the study, researchers will monitor changes in markers that indicate bone resorption, which is the process where bone is broken down and its minerals are released into the bloodstream.

By the end of the study, researchers aim to understand how the treatment affects bone health, specifically looking at markers like CTX, which is a circulating marker of bone resorption, and other markers related to bone formation. This information will help determine if the combination of dasatinib with quercetin or nicotinamide riboside can be a beneficial treatment for individuals with osteoporosis or osteopenia.

The research process

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

  1. Step 1

    Enrollment

    Upon joining the study, you will be asked to provide informed consent. This means you agree to participate after understanding the trial's purpose and procedures.

    Eligibility is based on specific criteria, including age between 60-90 years and certain bone density measurements.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate your current health status and bone density. This may involve blood tests and bone scans.

  3. Step 3

    Medication administration

    You will be given the medication dasatinib to take orally. The dosage and frequency will be explained to you by the study team.

    The medication will be taken for a specified duration as part of the trial protocol.

  4. Step 4

    Follow-up visits

    Regular follow-up visits will be scheduled to monitor your health and the effects of the medication. These visits may include additional blood tests and bone scans.

  5. Step 5

    Final assessment

    At the end of the 20-week period, a final assessment will be conducted to measure changes in bone resorption markers and other health indicators.

  6. Step 6

    Completion

    Upon completion of the trial, you will receive information about the study's findings and any further steps if necessary.

Who can join the trial?

5 criteria

  • Men and women aged 60-90 years.
  • Women must be more than 5 years past menopause, which is the time in a woman's life when her menstrual periods stop permanently.
  • Women must have hormone levels (FSH and LH) in the postmenopausal range, which means their hormone levels are consistent with being postmenopausal.
  • Have a T-score less than -1 at the total hip, femoral neck, or lumbar spine. A T-score is a measure used to assess bone density. A score less than -1 indicates low bone mass, which can increase the risk of osteoporosis.
  • Ability to provide informed consent, meaning you understand the study and agree to participate.

Who cannot join the trial?

7 criteria

  • Patients who have a history of severe allergic reactions to the study medications.
  • Patients who are currently taking medications that could interfere with the study drugs.
  • Patients with serious heart conditions, such as uncontrolled high blood pressure or heart failure.
  • Patients with severe liver or kidney disease.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial within the last 30 days.
  • Patients with any other medical condition that the study doctors believe would make it unsafe for them to participate.
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Investigated drugs

  • 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 improve bone health. Quercetin is thought to have properties that might help protect bones from damage and support their strength.

  • 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 reduce bone loss in people with low bone mass. It is believed to support the health of cells, which might contribute to stronger bones.

What is already known about the treatment

  • Dasatinib plus Quercetin

    This combination is taken orally and is being studied for its potential to help treat conditions like osteoporosis and osteopenia, which involve weakened bones. Currently, this combination is under investigation in clinical trials to determine its effectiveness and safety in reducing bone loss. Dasatinib and quercetin work together by targeting and removing damaged cells that contribute to bone deterioration, potentially improving bone health. They belong to a class of drugs known as senolytics, which aim to eliminate harmful cells that accumulate with age.

  • Nicotinamide Riboside

    Administered orally, nicotinamide riboside is being explored in clinical trials for its potential benefits in treating osteoporosis and osteopenia. This substance is still under investigation to assess its role in reducing bone loss and improving bone strength. At the molecular level, nicotinamide riboside is thought to enhance cellular energy production and repair, which may help maintain healthier bones. It is classified as a form of vitamin B3 and is being studied for its potential to support bone health by boosting cellular function.

Investigated diseases

  • Osteoporosis

    Osteoporosis is a condition characterized by weakened bones, which increases the risk of fractures. It occurs when the creation of new bone doesn't keep up with the removal of old bone. Over time, bones become porous and fragile. This disease often progresses silently without symptoms until a fracture occurs. Common fracture sites include the hip, spine, and wrist. As the disease advances, even minor stresses like bending over or coughing can cause fractures.

  • Osteopenia

    Osteopenia is a condition where bone mineral density is lower than normal but not low enough to be classified as osteoporosis. It is considered a precursor to osteoporosis and indicates a risk of developing the more severe condition. The progression involves a gradual decrease in bone density, which can lead to increased fragility. Unlike osteoporosis, osteopenia may not always result in fractures. However, it serves as a warning sign for potential future bone health issues. Regular monitoring of bone density is important to track its progression.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-500669-28-00Estimated enrolment120 patientsSponsorOdense University Hospital

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).