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Study on the Effects of Clodronate Disodium for Patients with Painful Knee Osteoarthritis

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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 knee osteoarthritis, a condition that causes pain and stiffness in the knee joint. The treatment being tested is called disodium clodronate, which is given as a solution for injection directly into the knee joint. The study aims to evaluate how well different doses of this treatment can reduce knee pain and how well patients tolerate it.

Participants in the study will receive either the treatment or a placebo, which looks like the treatment but does not contain the active substance. The study is designed to be adaptive, meaning it can adjust based on the results as it progresses. It is also randomized and double-blind, meaning neither the participants nor the researchers know who is receiving the treatment or the placebo, to ensure unbiased results. The study will take place over several weeks, with regular assessments to monitor pain levels and any side effects.

The main goal is to find the lowest dose of disodium clodronate that effectively reduces knee pain by at least 10 millimeters on a pain scale by the seventh week of the study. The safety and tolerability of the treatment will also be closely monitored, looking for any serious adverse events or signs of intolerance. This research will help determine the best dose to use in future studies and potentially offer a new treatment option for those suffering from painful knee osteoarthritis.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis of knee osteoarthritis, and pain levels.

    A signed informed consent form is required after a detailed discussion with the investigators.

  2. Step 2

    Baseline assessment

    Initial assessments include confirming knee pain levels using a visual analog scale (VAS) and ensuring a recent radiographic score is available.

    Female patients of childbearing potential must undergo a pregnancy test.

  3. Step 3

    Treatment phase

    The treatment involves the administration of disodium clodronate or a placebo via intra-articular injection.

    The solution is injected directly into the knee joint.

  4. Step 4

    Weekly follow-up visits

    Follow-up visits occur weekly to monitor pain levels and any side effects.

    Pain is assessed using the VAS, and other indices such as the Lequesne Algo-functional Index and WOMAC Index are evaluated.

  5. Step 5

    Week 7 assessment

    At week 7, the primary endpoint is assessed, which involves measuring the reduction in knee pain compared to the placebo group.

    The effectiveness of the clodronate dose is determined based on a reduction of 10 mm or more in the VAS score.

  6. Step 6

    Safety and tolerability evaluation

    Throughout the trial, safety and tolerability are monitored by recording any adverse events or abnormal laboratory results.

    The goal is to ensure the treatment is safe and well-tolerated by participants.

  7. Step 7

    End of trial

    The trial is expected to conclude by October 2025.

    Final assessments are conducted to gather comprehensive data on the treatment's efficacy and safety.

Who can join the trial?

6 criteria

  • Both female and male patients aged between 50 and 75 years can participate.
  • Participants must have a diagnosis of knee osteoarthritis (OA), which is a type of arthritis that affects the knee joint. This diagnosis should be confirmed by an X-ray taken within the last three months.
  • The X-ray should show a Kellgren-Lawrence radiographic score of 2 or 3. This score is a way to measure the severity of knee osteoarthritis.
  • Participants should have had knee pain for at least six months, with pain levels between 40 and 80 on a scale called the Visual Analogue Scale (VAS) at the screening visit. This pain level should be confirmed at the start of the study.
  • Female participants who can have children must have a negative pregnancy test before each treatment and during the study. They must also use reliable birth control methods throughout the study.
  • Participants must sign an informed consent form (ICF) after discussing the study details with the researchers. This form shows that they understand the study and agree to take part.

Who cannot join the trial?

5 criteria

  • Patients who are not experiencing knee osteoarthritis cannot participate. Knee osteoarthritis is a condition where the knee joint becomes worn down, causing pain and stiffness.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for specific types of participants.
  • Both male and female patients can participate, but those who do not identify as either may not be eligible.
  • Patients who are considered part of a vulnerable population cannot participate. Vulnerable populations include groups who may have additional risks or need special protection in research.
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Investigated drugs

Clodronate is being tested in this clinical trial for its effectiveness and safety in treating knee osteoarthritis. It is administered directly into the joint to help reduce pain and improve joint function. The trial aims to find the most effective dose that provides pain relief while minimizing side effects.

What is already known about the treatment

Clodronate – Clodronate is administered as an intra-articular injection, meaning it is directly injected into the joint space. It is currently being studied in clinical trials for its effectiveness and safety in treating knee osteoarthritis, a condition characterized by joint pain and stiffness. The main therapeutic indication for clodronate in this context is to alleviate knee pain associated with osteoarthritis. At the molecular level, clodronate works by inhibiting bone resorption, which is the process of breaking down bone tissue, thereby potentially reducing inflammation and pain in the joint. It is classified pharmacologically as a bisphosphonate, a group of drugs that prevent the loss of bone density.

Investigated diseases

Knee Osteoarthritis – Knee osteoarthritis is a degenerative joint disease characterized by the breakdown of cartilage in the knee joint. This condition leads to pain, stiffness, and swelling, which can worsen over time. As the cartilage wears away, bones may rub against each other, causing increased discomfort and reduced mobility. The progression of knee osteoarthritis can vary, with some individuals experiencing gradual worsening of symptoms, while others may have periods of stability. Factors such as age, weight, and previous joint injuries can influence the development and progression of the disease. Regular physical activity and maintaining a healthy weight can help manage symptoms and slow progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-511961-12-00Protocol codeSPA-S-899-01-21Estimated enrolment278 patientsSponsorSpa Societa Prodotti Antibiotici S.p.A.

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