Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-24 @ 5:09 PM
NCT ID:
NCT01415050
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT01415050
Study Brief:
Protocol Section:
NCT01415050