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 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
NCT ID:
NCT02554695
Eligibility Criteria:
* Inclusion Criteria:
* normal premenopausal women aged 25-40 years
* normal postmenopausal women aged 60-80 years
* at least 5 yrs since their last menses
* follicle stimulating hormone (FSH) \> 20 IU/L
* Exclusion Criteria:
* Abnormality in any of the screening laboratory studies
* Presence of significant liver or renal disease
* Malignancy (including myeloma)
* Malabsorption
* Diabetes
* Hypoparathyroidism
* Hyperparathyroidism
* Acromegaly
* Cushing's syndrome
* Hypopituitarism
* Severe chronic obstructive pulmonary disease
* Undergoing treatment with any medications that affect bone turnover, including the following:
* adrenocorticosteroids (\> 3 months at any time or \> 10 days within the previous yr)
* anticonvulsant therapy (within the previous year)
* pharmacological doses of thyroid hormone (causing decline of thyroid stimulating hormone below normal)
* calcium supplementation of \> 1200 mg/d (within the preceding 3 months)
* bisphosphonates (within the past 3 yrs)
* denosumab
* estrogen (E) therapy within the past year
* treatment with a selective E receptor modulator within the past year
* teriparatide within the past yr
* Clinical history of osteoporotic fracture (vertebral, hip, or distal forearm)
* Recent (within the past 6 months) fracture
* Serum 25-hydroxyvitamin D levels of \< 20 ng/ml
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
25 Years
Maximum Age:
80 Years
Study:
NCT02554695
Study Brief:
Protocol Section:
NCT02554695