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

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What is this study about?

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.

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 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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliero Universitaria Careggi	Florence	Italy

Other Sites

Site Name	City	Country
Fondazione Poliambulanza	Brescia	Italy
Azienda Sanitaria Locale Della Provincia Di Barletta Andria Trani	Andria	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Universita’ Degli Studi Di Verona	Verona	Italy
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione	Pavia	Italy
Ospedale Villa Scassi – Sampierdarena-ASL3-Azienda sociosanitaria ligure	Genoa	Italy
Ocspumfu Ieyipkjzrgg	Rome	Italy
Hudxfxof Oy Suz Pxtkks Fhtguwkpvtqyafzr	Rome	Italy
Upmuncooknqpxjlwh Dlknf Stvxt Dd Gnufpz	Genoa	Italy
Ogtchuzs Scc Pixhnvbazh	Castiglione delle Stiviere (MN)	Italy
Aqrnlsv Oudfhhrpcak Uyuwnxccpunoz Soexty	Siena	Italy
Afxpjaq Oildjkwdoll Nlkfcozya Sw Anloeps E Budxve E C Arqmqt Arrotqdgahw	Alexandria	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	01.03.2023

Trial locations

Investigated drugs:

Clodronate Disodium

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.

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 ID:

2024-511961-12-00

Protocol code:

SPA-S-899-01-21

NCT ID:

NCT06263517

Trial Phase:

Therapeutic use (Phase IV)

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

What is this study about?

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