Clinical trial: Denosumab In Addition To Intense Urate-Lowering Therapy for Bone Erosions (NCT02903446)

Eligibility criteria:
Inclusion Criteria:

          -  Age 30 years or older and able to provide informed consent

          -  Diagnosis of gout according to the American College of Rheumatology (ACR) / European
             League Against Rheumatism (EULAR) classification criteria

          -  Radiographic foot bone erosion attributable to gout and confirmed by a radiologist

          -  Serum urate of ≤ 5 mg/dL (300 µmol/L) or less*

        Exclusion Criteria:

          -  Treatment with bisphosphonates in the preceding 2 years

          -  Any prior treatment with denosumab

          -  Women of childbearing potential, who are not currently using birth control, are
             pregnant, planning to become pregnant, or are breast-feeding

          -  Men planning to conceive in the next 12 months

          -  Unstable systemic medical condition

          -  Uncontrolled hyperthyroidism

          -  Uncontrolled hypothyroidism

          -  History of Addison disease

          -  History of osteomalacia

          -  History of osteonecrosis of the jaw (ONJ)

          -  History of atypical femur fracture

          -  History of tooth extraction, jaw surgery, dental implants, or other dental surgery
             within the prior 6 months

          -  History of anorexia nervosa, bulimia (by history or physical) or obvious malnutrition.

          -  Invasive dental work planned in the next 2 years

          -  History of Paget's disease of bone

          -  Other bone diseases which affect bone metabolism

          -  Vitamin D deficiency [25(OH) vitamin D level < 20 ng/mL (<49.9 nmol/L)]†

          -  Hypercalcemia

          -  Elevated transaminases ≥ 2.0 x upper limit of normal (ULN)

          -  Elevated total bilirubin > 1.5x ULN

          -  History of any solid organ or bone marrow transplant

          -  Malignancy within the last 5 years (except cervical carcinoma in situ or basal cell
             carcinoma)

          -  Hypocalcemia

          -  Poorly tolerant of ULT including allopurinol, febuxostat, or probenecid

          -  Estimated glomerular filtration rate < 30 mL/minute/1.73 m^2

          -  Current use of any biological therapy (eg. infliximab, etanercept, adalimumab, etc.)

          -  Treatment history with pegloticase or another recombinant uricase

          -  Recipient of an investigational drug within 4 weeks prior to study drug administration
             or plans to take an investigational agent during the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.


Patient description (medical language): A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain.  The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint.  Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis.

Patient description (patient's own words): I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis.

Does the patient match the trial criteria? Contradiction