DISKO: Effect of denosumab on pain and bone marrow lesions in knee osteoarthritis

Phase 2

Completed

• Conditions: Osteoarthritis of the knee; Musculoskeletal Diseases; Musculoskeletal disorders

• Registration Number: ISRCTN96920058
• Lead Sponsor: The University of Manchester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-01
• Study Completion: 2020-10-30
• Last Update Posted: 5 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Current participant inclusion criteria as of 02/10/2019:
1. Age 40 years and over.
2. Ambulatory (not wheel chair bound), and able and willing to comply with the intervention and follow up.
3. Significant knee pain (have at least a score of 3 out of 10 on the primary symptom outcome of the trial, knee pain on a numerical rating scale (NRS Last week =3)
4. Evidence of significant OA on, x-ray – Kellgren Lawrence grade 2 or 3. Participants can have Kellgren and Lawrence grade 2 or 3 in any knee compartment.
5. Evidence of BMLs in index knee on magnetic resonance scanning (MRI)
6. Written informed consent

Previous participant inclusion criteria:
1. Age 50 years and over
2. Ambulatory (not wheel chair bound), and able and willing to comply with the intervention and follow up
3. Significant knee pain (have at least a score of 4 out of 10 on the primary symptom outcome of the trial, knee pain on a numerical rating scale (NRS Last week =4)
4. Evidence of significant OA on, x-ray – Kellgren Lawrence grade 2 or 3. Participants can have Kellgren and Lawrence grade 2 or 3 in any knee compartment.
5. Evidence of BMLs in index knee on magnetic resonance scanning (MRI)
6. Written informed consent

Exclusion Criteria

Current participant exclusion criteria as of 02/10/2019:
1. History of septic arthritis affecting the index knee
2. History of inflammatory arthritis
3. Current treatment for gout and/or acute attack of gout within the previous 5 years
4. GFR < 35 ml/min
5. Vitamin D level of < 50 nmol/l
6. Abnormal liver function (ALT or AST > twice upper limit of normal) or elevated total bilirubin > 1.5 x ULN
7. Potential participants with a positive Hepatitis B surface antigen (HBsAg) or hepatitis C test result or a history of immune-deficiency diseases, including a positive HIV test result
8. History of malignancy in the past 5 years (other than basal cell carcinoma)
9. History of any solid organ or bone marrow transplant
10. History of alcohol abuse within previous 12 months
11. Known hypersensitivity to Latex
12. Hereditary problems of fructose intolerance
13. Non-healed dental / oral surgery
14. History of cellulitis of the lower limb within the last 5 years, osteonecrosis of the jaw, osteonecrosis of the external auditory meatus or atypical femoral fracture
15. Unhealed open soft tissue lesions in the mouth
16. History of invasive dental surgery in previous 6 months and/or invasive dental work planned in the next 6 months
17. Current anorexia nervosa, suspected bulimia (by history or physical examination) or obvious malnutrition
18. Active inflammatory bowel disease or current or recent malabsorption syndrome.
19. Hypo or hyperparathyroidism
20. Hypocalcemia (Calcium < LLN) / hypercalcemia (Ca > Upper Limit of Normal [ULN])
21. Osteoporosis on bone active therapy
22. Current or recent Osteomalacia (within the last 5 years) or other bone diseases which may affect bone metabolism (osteopetrosis / osteogenesis imperfecta)
23. Suspected knee fracture
24. Intra-articular therapy in the knee within the previous 3 months
25. Prior antiresorptive therapy with bisphosphonates in the last year (oral therapy) or 3 years (IV therapy)
26. Prior treatment in the last year with strontium ranelate / HRT / raloxifene / testosterone
27. Previous knee surgery (including cartilage surgery) or arthroscopy within 6 months on the affected knee
28. Planned knee or hip surgery in the next 6 months
29. Currently having physiotherapy for knee OA
30. Women of childbearing potential currently pregnant or planning pregnancy or breast feeding
31. Women of childbearing potential and refusal to use at least one highly effective form of contraception (methods that can achieve a failure rate of less than 1% per year when used consistently and correctly) and to continue until 5 months following intervention.
32. Concurrent life threatening illness or any other condition that in the opinion of the investigator would compromise participants safety or data integrity
33. Contraindication to MRI such as implants which prohibit safe use of MRI scan including cochlear implants / metal objects in the body including certain joint prosthesis, cardia

Study & Design

• Study Type: Interventional
• Study Design: Not specified