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

NCT01415050 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2011-08-11

No results posted yet for this study

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.

Conditions

  • Osteoporosis in Post-menopausal Women

Interventions

DEVICE

Whole body vibration

15 times WBV

Sponsors & Collaborators

  • X-pert Med GmbH

    lead INDUSTRY

Principal Investigators

  • Egbert Seidel, Prof.Dr.med. · Zentrum für Physikalische und Rehabilitative Medizin des Sophien- und Hufeland-Klinikums Weimar

  • Matthias Rother, Dr.med.habil · X-pert Med GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2011-04-30
Completion
2011-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01415050 on ClinicalTrials.gov