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 @ 1:39 PM
Ignite Modification Date:
2025-12-24 @ 1:39 PM
NCT ID:
NCT03959995
Eligibility Criteria:
Inclusion Criteria:
* (early)postmenopausal women, ( normal menopause, 1-5 years post)
* Osteopenia and osteoporosis at the lumbar spine or femoral neck Bone Mineral Density (BMD) \<-1.0 standard deviation (SD) T-Score, WHO)
Exclusion Criteria:
* BMD \<-4.0 SD T-Score (BMD threshold for pharmaceutical therapy according to Dachverband Osteologie (DVO) guideline (mandatory for Germany, Austria, Suisse) for woman 50-60 years).
* Prevalent clinical, low-trauma fractures
* Diseases and drugs with relevant effects on bone and muscle metabolism (e.g. glucocorticoids \>7.5 mg/d or bisphosphonate therapy); individual case assessment
* Diseases and drugs with relevant effects on cardiometabolic risk factors (e.g. severe hypertension with corresponding medical therapy); individual case assessment
* Severe cardiovascular events (e.g. stroke, coronary infarction) in the past.
* Other conditions, diseases that exclude exercise training in a group (≤10 persons).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
48 Years
Maximum Age:
58 Years
Study:
NCT03959995
Study Brief:
Protocol Section:
NCT03959995