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:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-25 @ 2:31 AM
NCT ID:
NCT01889134
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of primary hyperparathyroidism
* Subjects able and willing to comply with the requirements of the protocol
Exclusion Criteria:
* Other diseases and medications known to interfere with bone or mineral metabolism, especially bisphosphonates used during the two-year period before this study
* Evidence of active malignancy
* Significant renal impairment as indicated by serum creatinine levels above the normalized range for age
* Significant hepatic dysfunction
* Malabsorption syndrome
* Active gastroduodenal ulcers
* Actual or planned pregnancy (in alendronate group females must not be planning to conceive during the two years following the study) or breast-feeding
* The lack of effective non-hormonal contraception in females with child-bearing capability (in alendronate group)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Study:
NCT01889134
Study Brief:
Protocol Section:
NCT01889134