Osteoporosis in Post-menopausal Women Clinical Trial
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
| Verified date | August 2011 |
| Source | X-pert Med GmbH |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Federal Institute for Drugs and Medical Devices |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | July 2011 |
| Est. primary completion date | April 2011 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | N/A and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | GP Office Dr. Baumann | Annaberg- Buchholz | |
| Germany | X-pert Med GmbH, MUC | Gräfelfing | |
| Germany | X-pert Med GmbH, Jena | Jena | |
| Germany | Sportmedizin Stockach | Stockach | |
| Germany | Sophien- und Hufeland- Klinikum GmbH | Weimar |
| Lead Sponsor | Collaborator |
|---|---|
| X-pert Med GmbH |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | Fall risk | Changes in Fall Risk (Tinetti Mobility test) from baseline to week 6 | 6 weeks | Yes |
| Secondary | Low back pain | Changes in low back pain (100 mm VAS) from baseline to week 6 | 6 weeks | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03162068 -
Cushing's Osteoporosis Specificities
|
N/A |