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Adaptative, multicenter, randomized, double-blind, parallel-group, placebo controlled, clinical trial, on the efficacy and tolerability of different escalating doses of intra-articular clodronate in patients with painful knee osteoarthritis
EU CTIS ID: 2024-511961-12-00
What this study is testing
PHASE II - to assess the safety and tolerability of different escalating doses of IA clodronate in terms of serious adverse events (SAEs), adverse events (AEs), and abnormal laboratory or any clinical signs of intolerance. - to set the DTD to be used in Phase III, as the lowest clodronate dose leading to a ≥ 8.5 mm reduction in the VAS of knee pain at Week 7 vs. Placebo. PHASE III - to assess and confirm the therapeutic efficacy of DTD in patients with knee OA based on VAS score of knee pain at Week 7 vs. Placebo. - to assess the safety and tolerability of DTD in patients with knee OA in terms of SAEs, AEs, and abnormal laboratory or any clinical signs of intolerance.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Female and male patients aged 50 up to 75 years at the signature of informed consent form (ICF).
- Diagnosis of knee OA according to the American College of Rheumatology, confirmed by Rx during the screening (a Rx performed in the last three (3) months before Screening Visit is accepted).
- Kellgren-Lawrence radiographic score between 2 and 3 degrees in the tibiofemoral joint.
- Symptomatic knee OA (pain) since at least 6 months with a knee pain (VAS) ranging between 40 and 80 mm at Screening visit (the figure should be confirmed at Baseline).
- Female patients of childbearing potential must have a negative pregnancy test before each treatment and during the Visit 5 – Week 4 and they must use adequate methods of contraception throughout the course of the study.
- A signed ICF by the patient after exhaustive study discussion with the investigators.
You likely can't join if
- BMI > 35 kg/m2 (Class II obesity).
- Any treatment with denosumab in the 12 months before Baseline.
- Any treatment with paracetamol in the twelve (12) hours before Baseline.
- Any knee surgery in the past or knee arthroplasty.
- Any diagnostic or surgical arthroscopy of the knee in the six (6) months before Baseline.
- Any jaw osteonecrosis in the last twenty-four (24) months before Baseline or at a risk of jaw osteonecrosis.
See the full eligibility criteria
- Female and male patients aged 50 up to 75 years at the signature of informed consent form (ICF).
- Diagnosis of knee OA according to the American College of Rheumatology, confirmed by Rx during the screening (a Rx performed in the last three (3) months before Screening Visit is accepted).
- Kellgren-Lawrence radiographic score between 2 and 3 degrees in the tibiofemoral joint.
- Symptomatic knee OA (pain) since at least 6 months with a knee pain (VAS) ranging between 40 and 80 mm at Screening visit (the figure should be confirmed at Baseline).
- Female patients of childbearing potential must have a negative pregnancy test before each treatment and during the Visit 5 – Week 4 and they must use adequate methods of contraception throughout the course of the study.
- A signed ICF by the patient after exhaustive study discussion with the investigators.
- BMI > 35 kg/m2 (Class II obesity).
- Any treatment with denosumab in the 12 months before Baseline.
- Any treatment with paracetamol in the twelve (12) hours before Baseline.
- Any knee surgery in the past or knee arthroplasty.
- Any diagnostic or surgical arthroscopy of the knee in the six (6) months before Baseline.
- Any jaw osteonecrosis in the last twenty-four (24) months before Baseline or at a risk of jaw osteonecrosis.
- Any known hypersensitivity to the drug in the study and to its excipients or other bisphosphonates, and any hypersensitivity to paracetamol (rescue drug).
- Any participation in a clinical study in which the last administration of the investigational medicinal product was within two (2) weeks before consenting to study participation (i.e. signing ICF).
- Inadequate organ function defined by the following laboratory parameters: Absolute Neutrophil Count (ANC) < 1500/^l ; Haemoglobin (Hb) < 9 g/dl (< Hb 5.6 mmol/L) ; Platelet Count < 100.000/^l ; Serum Creatinine > 1.5 x ULN or eGFR < 60 mL/min (as per Cockroft-Gault formula) ; ALT or AST > 1.5 x ULN ; Serum Total Bilirubin > 1.5 x ULN
- Pregnant or breastfeeding women, or women planning to become pregnant during the study.
- Any positive or suspected history of alcoholism or drug use.
- Joint instability due to other reasons than knee OA, such as f.i. algo dystrophic syndrome, either partial or complete rupture of internal / externals ligaments, kneecap instability, etc.
- Clinically significant (i.e.) gastrointestinal, renal, hepatic, pulmonary, cardiovascular or neurological disease that could interfere with the outcome of the study or the patient’s ability to comply with study requirements.
- Patients unwilling or unable to comply with the protocol.
- Otherwise located lower limb pain, such as hip pain.
- Other musculoskeletal disorders related to the target knee.
- Any treatment with IA drugs in the last three (3) month before Day 0- Baseline (including any formulation of corticosteroids, or hyaluronic acid injections).
- Corticosteroid use by any systemic route, and hyaluronic acid injections or in-tra-articular corticosteroids for any other joint in the previous month will be not permitted.
- Any treatment with systemic non-steroidal anti-inflammatory drugs (NSAIDs) in the week before Baseline, or any steroid anti-inflammatory drugs and chon-droprotective drugs in the thirty (30) days before Baseline.
- Any treatment with systemic bisphosphonates in the last twelve (12) months before Baseline.
- Any treatment with glucosamine or chondroitin sulfate, diacerein and matrix metalloproteinase (MMP) inhibitors in the 4 weeks before Baseline.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.