A PHASE 2, SINGLE-CENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, EFFICACY AND SAFETY STUDY OF ZOLEDRONATE IN SUBJECTS WITH EROSIVE HAND OSTEOARTHRITIS - ZOLEHO

• Conditions: Erosive hand osteoarthritis; MedDRA version: 12.1Level: LLTClassification code 10019115Term: Hand osteoarthritis

• Registration Number: EUCTR2010-019110-24-DE
• Lead Sponsor: niversitätsklinikum Erlangen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-04
• Last Update Posted: 24 March 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified