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

NCT01415050 | Completed Phase 2 DMC

• 1 other identifier: XPM-022
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 5

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.

Conditions

Osteoporosis in Post-menopausal Women

Keywords

Osteoporosis; Menopause; Raloxifane; Alendronate

Outcome Measures

Primary Outcomes (1)

• Biomarkers of bone formation and resorption

  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

  6 weeks

Secondary Outcomes (2)

• Fall risk

  6 weeks

• Low back pain

  6 weeks

Study Arms (2)

Alendronate

ACTIVE COMPARATOR

Device: Whole body vibration

Raloxifane

ACTIVE COMPARATOR

Device: Whole body vibration

Interventions

Whole body vibration DEVICE

15 times WBV

Alendronate; Raloxifane

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• X-pert Med GmbH: lead

Study Sites (5)

GP Office Dr. Baumann

Annaberg-Buchholz, 09456, Germany

Location

X-pert Med GmbH, MUC

Gräfelfing, 82166, Germany

Location

X-pert Med GmbH, Jena

Jena, 07745, Germany

Location

Sportmedizin Stockach

Stockach, 78333, Germany

Location

Sophien- und Hufeland- Klinikum GmbH

Weimar, 99425, Germany

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Egbert Seidel, Prof.Dr.med.

  Zentrum für Physikalische und Rehabilitative Medizin des Sophien- und Hufeland-Klinikums Weimar

  PRINCIPAL INVESTIGATOR

• Matthias Rother, Dr.med.habil

  X-pert Med GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 1, 2011
• First Posted: August 11, 2011
• Study Start: January 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: July 1, 2011
• Last Updated: August 11, 2011

Record last verified: 2011-08

Locations

DE (5)