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 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT01826656
Eligibility Criteria:
Inclusion Criteria:
* Caucasian women, \> 50 years old
* women referring to have reached a menopause status, defined as the permanent cessation of the ovulation, since at least 1 year and presenting a diagnosis of osteoporosis based on dual X-rays energy absorptiometry (DXA) measurement of the bone mineral density at the femur neck or lateral spine (t value 2.5 SD or more below the young female adult mean) (TEST GROUP)
* women in menopausal status since at least 1 year and with normal bone mineral density, as assessed by DXA scan (CONTROL GROUP)
* subjects needing a tooth extraction. The tooth to extract should present at least 30% of its attachment level preserved. Wisdom teeth are excluded from this study
* Subjects must have voluntarily signed the informed consent.
Exclusion Criteria:
* on hormone replacement therapy (HRT) or taking any other drugs (except Vit D and calcium) for the treatment of osteoporosis (e.g. biphosphonates)
* on chronic treatment (i.e., two weeks or more) with any medication known to affect oral status (e.g., phenytoin, cyclosporine, and non-steroidal anti-inflammatory drugs) within one month from baseline visit.
* affected by systemic diseases recognized to affect bone metabolism (e.g. Cushing's syndrome, Addison's disease, non-controlled diabetes mellitus, leukemia, pernicious anemia, malabsorption syndromes, chronic liver disease, rheumatoid arthritis..)
* on therapy with drugs that can affect bone metabolism (e.g. glucocorticoids, anticonvulsants, anticoagulants, benzodiazepines, cytotoxic drugs, immunosuppressants..)
* affected by any known diseases, infections or recent surgical procedures within 30 days of study initiation.
* knowingly have HIV or Hepatitis
* history of local radiation therapy
* affected by limited mental capacity or language skills such that study information cannot be understood, informed consent cannot be obtained, or simple instructions cannot be followed.
* presented an acute endodontic lesion in the test tooth or in the neighbouring areas to the experimental procedure
* smokers
* suffering from a known psychological disorder
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
50 Years
Study:
NCT01826656
Study Brief:
Protocol Section:
NCT01826656