Erosive hand osteoarthritis MedDRA version: 12.1 Level: LLT Classification code 10019115 Term: Hand osteoarthritis
Conditions
Interventions
Trade Name: Aclasta
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: ZOLEDRONIC ACID
CAS Number: 118072-93-8
Current Sponsor code: zol446
Concentration unit: mg milligram(s)
Concentra
Sponsors
Universitätsklinikum Erlangen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 1. Must understand and voluntarily sign an informed consent form 2. Male or female, must be aged = 18 years at time of consent 3. Must have a diagnosis of erosive hand osteoarthritis according to ACR criteria for at least six months 4. Must have at least two bone erosions detectable in conventional radiographs of the hands at the first carpo-metacarpal joint (CMC) and/or proximal and/or distal interphalangeal joints (radiographs must not be older than one year). 5. Must have active disease at screening with at least two swollen and tender proximal interphalangeal (PIP) and/or distal interphalangeal (DIP) joints 6. Must have a value of at least 40 on the VAS in the patient self-assessment of pain at screening 7. Must have negative serum rheumatoid factor (RF) and cyclic ciytrulinated peptide antibody (CCP) 8. Must be able to adhere to the study visit schedule and other protocol requirements 9. Females must be postmenopausal for at least 24 consecutive months or must have undergone a hysterectomy or bilateral oophorectomy 10. Must meet the following laboratory criteria: ? Haemoglobin = 9 g/dL ? Haematocrit = 27% ? White blood cell (WBC) count = 3,000/µL (= 3.0 X 109/L) and = 14,000/µL (= 14 X 109/L) ? Neutrophils = 1,500/µL (= 1.5 X 109/L) ? Platelets = 100,000/µL (= 100 X 109/L) ? Serum creatinine = 1.5 mg/dL (= 132.6 µmol/L) ? Creatinine clearance = 35 ml/min ? Total billirubin = 2.0 mg/dL ? Aspartate transaminase (AST [serum glutamic oxaloacetic transaminase, SGOT]) and alanine transaminase (ALT [serum glutamate pyruvic transaminase, SGPT]) = 1.5x upper limit of normal (ULN) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. 1. History of malignancy within the previous 5 years 2. History of any clinically significant cardiac, endocrine, pulmonary, neurological, psychiatric, hepatic, renal, haematological, immunologic, or other major disease 3. Any clinically significant abnormality on 12-lead ECG at screening 4. History of parathyroid surgery or malabsorption of any kind including previous resection of the small intestine 5. History of or treatment for aspirin-sensitive bronchial asthma 6. Planned dental surgery within the following 12 months from Day 1 of the study 7. Human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus infection 8. History of serious infections (e.g. pneumonia, pyelonephritis) in the previous 3 months 9. History of alcohol or substance abuse within the preceding 6 months that, in the opinion of the investigator, may increase the risks associated with study participation or study medication administration, or may interfere with interpretation of results 10. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study 11. Laboratory finding of hypocalcaemia at screening or current treatment for hypocalcaemia 12. History of any clinically significant inflammatory disease other than EHOA, especially, but not limited to, rheumatoid arthritis or spondylarthropathies 13. History or diagnosis of fibromyalgia 14. Evidence of gout, pseudogout or haemochromatosis 15. Evidence of calcium pyrophosphate deposition disease ( CPPD) 16. Significant injury to the affected joint within six months prior to screening 17. History of infected joint or joint prosthesis within the previous 5 years 18. Any anti-inflammatory or immunosuppressive therapy for any condition including, but not limited to glucocorticoids, methotrexate, sulfasalazine, leflunomide, chloroquine, hydroxychloroquine, gold compounds, penicillamine, cyclosporine, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, tacrolimus, and azathioprine within 35 days prior to randomization 19. Use of aminoglycoside antibiotics, loop diuretics and any other nephrotoxic drugs within 35 days prior to randomization 20. Use of NSAIDs within seven days prior to screening 21. Intra-articular injection of corticosteroids three months prior to randomization 22. Intra-articular injection of hyaluronate within six month prior to randomization 23. Use of any investigational medication within six months prior to randomization 24. Use of “nutriceuticals” and alternative medicine products, if not taken in a stable dose for a minimum of three month prior to randomization 25. Patients not able to take daily calcium and vitamin D supplements 26. Patients who participated in this study before 27. Patients who possibly are dependent on the sponsor or investigator 28. Patients who have not given consent to the sharing of their pseudonymized data according to §§7(2)15, 12 and 3 GCP-V
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the 90-day symptomatic efficacy of a single dose zoledronate (Aclasta ®) 5 mg IV, compared with placebo, for the treatment of erosive hand osteoarthritis;Secondary Objective: • To determine the effect of a single dose zoledronate (Aclasta ®) 5 mg IV, compared with placebo, on pain and function in patients with erosive hand osteoarthritis • To determine the effect of a single dose zoledronate (Aclasta ®) 5 mg IV, compared with placebo, on disease activity in patients with erosive hand osteoarthritis • To determine the effect of a single dose zoledronate (Aclasta ®) 5 mg IV, compared with placebo, on quality of life in patients with erosive hand osteoarthritis • To evaluate the safety and tolerability of a single dose zoledronate (Aclasta ®) 5 mg IV, compared with placebo, in patients with erosive hand osteoarthritis ;Primary end point(s): Proportion of subjects in each treatment group who achieve a 50% improvement in Australian/Canadian hand arthrosis pain scale (AUSCAN) Index at Day 90 compared with baseline. | — |
Countries
Germany
Outcome results
None listed