Clinical trial: Zurich Disability Prevention Trial (NCT01017354)

Eligibility criteria:
Inclusion criteria:

          -  Age 70+

          -  Fall in the last 12 months before screening (with or without a fracture)

          -  Living at home (community-dwelling)

          -  Men or women

          -  Mobile with or without walking aid - have to be able to use public transportation to
             attend the clinical visits at the trial centre

          -  Score of at least 27 at the screening Folstein Mini Mental test + normal clock test

          -  Patient understands the study procedures, alternative treatments available and risks
             involved with the study, and voluntarily agrees to participate by giving a written
             informed consents.

          -  Patient meets the entry minimal requirements based on routine clinical laboratory
             safety screening tests and the Folstein mini mental status (score 27+ required)
             performed at the Screening Visit.

          -  Patient is willing to perform all study tests, attend all required office visits, and
             provide blood and urine samples.

        Exclusion criteria:

          -  Serum calcium adjusted for albumin of > 2.6 nmol/l

          -  Pathologic fracture in the last year (except for fractures due to osteoporosis)

          -  Chemo therapy / Radiation due to cancer in the last year

          -  Treatment which has an effect on bone metabolism (e.g. bisphosphonate, PTH,
             calcitonin, chronic cortisone intake > XYmg/day for more than XY month/years (except
             for inhalation and sporadic infiltration))

          -  Oral vitamin D intake of more than 800 IU per day

          -  Unwilling to stop calcium supplementation and vitamin D supplementation during the
             trial (maximal calcium supplement intake 250mg/d; no additional vitamin D
             supplementation)

          -  Severe visual or hearing impairment

          -  Unwilling or unable to take study medication

          -  Diseases with a risk of recurrent falling (e.g. Parkinson's disease/syndrome,
             Hemiplegia after stroke, symptomatic stenosis of the spinal canal, polyneuropathy,
             epilepsy, recurring vertigo, recurring syncope)

          -  BMI >= 40

          -  Estimated creatinine clearance < 15 ml/min (estimated Creatinine Clearance Cockcroft
             and Gault)

          -  Malabsorption syndrome (celiac diseases, inflammatory bowl disease)

          -  Diseases that may enhance serum calcium: sarcoidosis, lymphoma, primary
             hyperparathyroidism

          -  kidney stone in the last 10 years

          -  Abnormal indices of calcium metabolism, uncontrolled hypocalcemia.

          -  Patient heavily consumes alcohol containing products defined as greater than (>) 3
             drinks (beer, wine, or distilled spirits) of alcoholic beverages per day.

          -  Patient is unlikely to adhere to the study procedures, to keep appointments, or is
             planning to relocate during the study.

          -  Patients who are planning a stay in a "sunny" location (e.g. winter sun resort) for
             more than two months per year

          -  Medication which has an effect on 25-hydroxyvitamin D level (e.g. certain
             anticonvulsants (e.g. Phenobarbital, Carbamazepin, Phenytoin))

          -  M. Paget (Ostitis deformans)

          -  inflammatory arthritis (e.g. rheumatoid arthritis, reiter syndrome, psoriasis
             arthritis)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 70 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? Contradiction