Clinical trial: Safety and Efficacy of Whole-body Vibration as add-on Treatment of Osteoporosis in Post-menopausal Women (NCT01415050)

Eligibility criteria:
Inclusion Criteria:

          -  Ambulatory postmenopausal women, who had their last menstrual period at least 2 years
             before beginning the study

          -  Free of severe acute or chronically disabling conditions with a life expectancy of at
             least 5 years

          -  Expected to remain ambulatory throughout the entire study and expected to return for
             all study visits

          -  Expected to be compliant with study procedures, including procedures for WBV usage

          -  Women who have no language barrier, are cooperative, and who give informed consent
             before entering the study

          -  Women must be on standard therapy with alendronate or raloxifene for at least 3 months
             before the commencement of WBV, and their treatment must be expected to remain stable
             throughout the study

        Exclusion Criteria:

          -  Participation in another clinical study within the last 30 days and/or during the
             study

          -  Subjects who are inmates of psychiatric wards, prisons, or any other state
             institutions

          -  Investigators or any other team member involved directly or indirectly in the conduct
             of the clinical study

          -  Thrombophlebitis, deep venous thrombosis, any thromboembolic disorders (including
             pulmonary or retinal embolism) within the last year

          -  Any vascular disorders of the lower extremities with the exception of asymptomatic
             varicosis

          -  Current bone disorders other than primary osteoporosis, such as hyperparathyroidism,
             Paget's disease, renal osteodystrophy, osteomalacia, osteonecrosis, spondylolisthesis

          -  Vertebral fracture or fractures of the lower extremities within the last 6 months
             before start of WBV

          -  Frequent occurrence of muscle spasms limiting the use of WBV

          -  Spastic disorders

          -  Morbus Sudeck (CRPS I)

          -  Malignancy within the past 2 years with the exception of in situ removal of basal cell
             carcinoma

          -  Severe cardiovascular disorder, such as but not limited to: not controllable
             hypertension, clinically relevant cardiac arrhythmia and cardiac valve disorder, heart
             failure (NYHA III-IV)

          -  Cerebral vascular accident within the past 1 year

          -  Any neurologic/psychiatric disorder which might interfere with the conduct of the
             trial or the study results such as, but not limited to, the following: Depression,
             schizophrenia, dementia, Parkinson's disease, epilepsy

          -  Benign Paroxysmal Positional Vertigo

          -  Frequent occurrence of migraine attacks (more than once per month), limiting the use
             of WBV

          -  Active renal lithiasis or gall stones as defined by any colic within 6 months prior to
             start of WBV

          -  Acute inflammation, infection and/or fever

          -  Immune compromised conditions such as, but not limited to, rheumatoid arthritis, HIV

          -  severe diabetes, e.g. defined by the coexistence of an arterial occlusive disease

          -  Major surgical interventions within 3 months prior to WBV

          -  Metallic or plastic implants like joint implants, pace makers, cardiac valves, stents,
             eye lenses that limit the use of WBV

          -  Any acute joint inflammation of the lower extremities or other parts of the body which
             might interfere with the use of WBV within the last 6 months before start of WBV

          -  Start or change in regimen of physical therapy, or extreme sportive activity within 1
             month prior to study and during the study

          -  Treatment with doses of any of the following medications more recently than 6 months
             before beginning the study: Androgen, Calcitonin, Estrogen, Progestin, strontium
             ranelate, parathormone, proton pump inhibitors

          -  Long term treatment (more than 6 months) with Heparin within the last 2 years

          -  Patients in the alendronate group must be naïve to other bisphosphonates and raloxifen

          -  Patients in the raloxifen group must be naïve to all bisphosphonates

          -  Treatment with WBV within the last 6 months

          -  Treatment with therapeutic doses of systemic corticosteroids for more than 1 month
             during the 12 months before beginning the study

          -  Treatment with 50,000 IU or more of vitamin D once weekly more recently than 3 months
             before beginning the study
Female
No healthy subjects accepted to join the trial.



Patient description (medical language): A 55-year-old white woman comes for a routine checkup.  She has no significant medical history and does not use tobacco, alcohol, or illicit drugs.  The patient's only medication is an over-the-counter multivitamin.  Family history is notable for a hip fracture in her mother.  Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis.

Patient description (patient's own words): I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis.

Does the patient match the trial criteria? Contradiction