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 @ 4:39 PM
Ignite Modification Date:
2025-12-24 @ 4:39 PM
NCT ID:
NCT01329666
Eligibility Criteria:
Inclusion Criteria:
1. Females and males \>= 45 years of age
2. PHPT, defined as elevated PTH with elevated serum calcium
3. Screening 25-OHD \<= 20 ng/ml
Exclusion Criteria:
1. Pre-menopausal
2. Serum calcium is \>11.5mg/dl.
3. Urinary calcium is \>350 mg/dl.
4. Active nephrolithiasis
5. Nephocalcinosis
6. Known sensitivity to tetracycline (Sumycin)
7. Familial history of hyperparathyroid syndromes
8. Bisphosphonate use within past 2 years.
9. Current use of Prolia.
10. Current use of Cinacalcet.
11. Currently using Cimetidine.
12. Currently use Colestipol.
13. Currently using Orlistat.
14. Current or past malignancy, except cured basal or squamous cell skin carcinoma or other cancers that have not recurred for at least five years.
15. Current tuberculosis, or history of Sarcoidosis, HIV/AIDS, chronic kidney disease (serum creatinine \>= 1.5), liver disease, Crohn's Disease, Celiac Disease, or gastric bypass
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT01329666
Study Brief:
Protocol Section:
NCT01329666