Safety and Efficacy of Whole-body Vibration as add-on Treatment of Osteoporosis in Post-menopausal Women

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