Status:
COMPLETED
Safety and Efficacy of Whole-body Vibration as add-on Treatment of Osteoporosis in Post-menopausal Women
Lead Sponsor:
X-pert Med GmbH
Conditions:
Osteoporosis in Post-menopausal Women
Eligibility:
FEMALE
Phase:
PHASE2
Brief Summary
Multicentered, randomized study of safety and efficacy of whole-body vibration (WBV) as add on to standard pharmacological treatment of osteoporosis (alendronate 70 mg/ week or raloxifene 60 mg/day) i...
Detailed Description
Objectives Primary 1. To establish the effect of whole-body vibration (WBV) on biomarkers of bone remodelling in postmenopausal women with osteoporosis. 2. To establish the effect of whole-body vibra...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2011
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01415050
Start Date
January 1 2009
End Date
July 1 2011
Last Update
August 11 2011
Active Locations (5)
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1
GP Office Dr. Baumann
Annaberg-Buchholz, Germany, 09456
2
X-pert Med GmbH, MUC
Gräfelfing, Germany, 82166
3
X-pert Med GmbH, Jena
Jena, Germany, 07745
4
Sportmedizin Stockach
Stockach, Germany, 78333