Clinical trial: RANKL-blockade for the Treatment of Erosive Osteoarthritis (OA) of Interphalangeal Finger Joints (NCT02771860)

Eligibility criteria:
Inclusion Criteria:

          -  • Subjects with hand OA having suffered from transient inflammatory attacks of the
             interphalangeal finger joints characteristic for what has been termed 'inflammatory'
             or 'erosive' hand OA.

               -  Subjects with hand OA showing inflammatory signs, either clinically or
                  ultrasonographically, of the interphalangeal finger joints.

               -  Subjects with hand OA in which at least 1 interphalangeal finger joint has the
                  typical appearance on the X-rays of a 'J' or 'E' phase joint as defined by the
                  criteria mentioned above.

               -  Subjects with hand OA where at least 1 interphalangeal finger joint in the 'J' or
                  'E' phase presents a palpable swelling.

        Exclusion Criteria:

          -  • Patients with known hypersensitivities to mammalian-derived drug preparations.

               -  Patients with clinically significant hypersensitivity to any of the components of
                  Prolia.

               -  Current and/or Prior treatment with any investigational agent within 90 days, or
                  five half-lives of the product, whichever is longer.

               -  Previous administration of denosumab from clinical trials or others (e.g.
                  commercial use).

               -  Vitamin D deficiency [25(OH) vitamin D level < 20 ng/mL (< 49.9 nmol/L)].
                  Possibility of replenishment and re-screening.

               -  Subjects with current hypo- or hypercalcemia (normal serum calcium levels:
                  8.5-10.5 mg/dl or 2.12-2.62 mmol/L).

               -  Patients currently under bisphosphonate (BP) treatment or any use of oral BPs
                  within 12 months of study enrollment or intravenous BPs or strontium ranelate
                  within 5 years of study enrollment

               -  Prior use of any chondroprotective drug within 90 days e.g. chondroitin sulfate,
                  glucosamine, avocado-soybean unsaponifiables, tetracyclins, corticosteroids.

               -  Prior use of any immunomodulating drug with possible effects on proinflammatory
                  cytokine metabolism within 90 days a.o. corticosteroids, methotrexate,
                  sulfasalazine, leflunomide, D-Penicillin, anti-malarials, cytotoxic drugs, TNF
                  (tumor necrosis factor) blocking agents.

               -  History of drug or alcohol abuse in the last year.

               -  Patients suffering from chronic inflammatory rheumatic disease (e.g. rheumatoid
                  arthritis, spondylarthropathy, psoriatic arthritis, gout, chondrocalcinosis or
                  other auto-immune diseases, e.g. systemic lupus erythematosus).

               -  History of cancer or lymphoproliferative disease other than a successfully and
                  completely treated squamous cell or basal cell carcinoma of the skin or cervical
                  dysplasia, with no recurrence within the last two years.

               -  History of any Solid Organ or Bone Marrow Transplant.

               -  Comorbidities: significant renal function impairment (glomerular filtration < 30
                  ml/min/1.73m2 or <50% of normal value), uncontrolled diabetes, unstable ischemic
                  heart disease, congestive heart failure (NYHA III, IV), uncontrolled hypo or
                  hyperparathyroidism, active inflammatory bowel disease, malabsorption, liver
                  failure or chronic hepatic disease (serum AST (aspartate aminotransferase )/ ALT
                  (alanine aminotransferase) levels 3 times above normal), recent stroke (within
                  three months), chronic leg ulcer and any other condition (e.g,. indwelling
                  urinary catheter) which, in the opinion of the investigator, would put the
                  subject at risk by participation in the protocol.

               -  Subject has any kind of disorder that compromises the ability of the subject to
                  give written informed consent and/or to comply with study procedures .

               -  Patient who is pregnant or planning pregnancy; if the female subject is of
                  child-bearing age, she must use a valid mean of contraception during the study
                  and for 9 months after last dose of study medication. For males with a partner of
                  childbearing potential: subject refuses to use 1 effective methods of
                  contraception for the duration of the study and for 10 months after the last dose
                  of study medication.

               -  Female subjects who are breast-feeding.

               -  History of osteonecrosis of the jaw, and/or recent (within 3 months) tooth
                  extraction or other unhealed dental surgery; or planned invasive dental work
                  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 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? Entailment