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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01415050
Recruitment Status : Completed
First Posted : August 11, 2011
Last Update Posted : August 11, 2011
Information provided by:
X-pert Med GmbH

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) in post-menopausal women.

After informed consent of the patients has been obtained, each patient's potential eligibility will be assessed during a "Screening Visit". Eligible subjects will be stratified into two groups: those that are on treatment with alendronate and those that are on treatment with raloxifene.

Subsequently, at baseline, the patients in each group are randomised to receive either WBV or no WBV during the first segment of the study. Baseline evaluation of biomarkers of bone remodelling, fall risk and back pain will be performed before starting the first segment. Patients will return for efficacy and safety evaluations at week 3 and week 6. At 6 weeks after baseline the second segment of the study starts: patients that were on WBV during segment I will be observed for another 6 weeks without WBV, whereas the patients that did not receive WBV during segment I will now be treated with WBV for 6 weeks in segment II. All patients will return for additional visits at week 9 and 12 for safety and efficacy evaluation.

Condition or disease Intervention/treatment Phase
Osteoporosis in Post-menopausal Women Device: Whole body vibration Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multicentered, Randomized Study of Safety and Efficacy of Whole-body Vibration as add-on to Standard Pharmacological Treatment of Osteoporosis in Post-menopausal Women
Study Start Date : January 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Alendronate Device: Whole body vibration
15 times WBV
Active Comparator: Raloxifane Device: Whole body vibration
15 times WBV

Primary Outcome Measures :
  1. Biomarkers of bone formation and resorption [ Time Frame: 6 weeks ]
    1. Changes in markers of bone formation (N-terminal propeptide of type-1 procollagen - P1NP) and bone resorption (cross links of N-terminal telopeptide of type 1 collagen - N-Tx) from baseline to week 6

Secondary Outcome Measures :
  1. Fall risk [ Time Frame: 6 weeks ]
    Changes in Fall Risk (Tinetti Mobility test) from baseline to week 6

  2. Low back pain [ Time Frame: 6 weeks ]
    Changes in low back pain (100 mm VAS) from baseline to week 6

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01415050

GP Office Dr. Baumann
Annaberg- Buchholz, Germany, 09456
X-pert Med GmbH, MUC
Gräfelfing, Germany, 82166
X-pert Med GmbH, Jena
Jena, Germany, 07745
Sportmedizin Stockach
Stockach, Germany, 78333
Sophien- und Hufeland- Klinikum GmbH
Weimar, Germany, 99425
Sponsors and Collaborators
X-pert Med GmbH
Principal Investigator: Egbert Seidel, Zentrum für Physikalische und Rehabilitative Medizin des Sophien- und Hufeland-Klinikums Weimar
Study Director: Matthias Rother, X-pert Med GmbH

Responsible Party: Dr. med. habil. Matthias Rother, X-pert Med GmbH Identifier: NCT01415050     History of Changes
Other Study ID Numbers: XPM-022
First Posted: August 11, 2011    Key Record Dates
Last Update Posted: August 11, 2011
Last Verified: August 2011

Keywords provided by X-pert Med GmbH:

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Bone Density Conservation Agents
Physiological Effects of Drugs