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 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT04736693
Eligibility Criteria:
Criteria:
Please see https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.
Eligible cohort entry dates:
Zoledronic acid indication for treatment of postmenopausal women with osteoporosis was approved by FDA on Aug 20, 2007.
* For IBM MarketScan: Aug 21, 2007 - December 31, 2018 (end of available data)
* For Optum CDM: Aug 21, 2007 - Mar 31, 2020 (end of available data)
Inclusion Criteria:
* Postmenopausal women between the ages of 65 and 89 years
* Osteoporosis diagnosis
Exclusion Criteria:
* Bisphosphonate users
* Previous use of:
1. Any use of parathyroid hormone
2. Use of anabolic steroids or growth hormone within 6 months before cohort entry date OR
3. Use of oral or intravenous systemic corticosteroids within 12 months of cohort entry date
* Serious disease that may limit life expectancy to less than 6 months
* Malignant neoplasm diagnosis within 12 months prior to the cohort entry date
* Conditions that influence bone metabolism
* Treatment and Prevention of Glucocorticoid-Induced Osteoporosis
* Treatment of Paget's Disease of Bone
* Alcohol abuse/dependence OR Drug abuse/dependence OR Non-compliance
* Pregnancy
* Diagnosis and procedure for amputee of lower limb
* Use of Zoledronic acid within 450 days prior to the cohort entry date
* Use of Denosumab within 450 days prior to the cohort entry date
* Diagnosis of End-Stage Renal Disease OR Diagnosis and procedure for Kidney transplant
* Diagnosis of End-Stage Liver Disease: Cirrhosis, Hepatic decompensation
* Blindness or compromised vision
* Use of Abaloparatide within 450 days prior to the cohort entry date
* Use of Romosozumab within 450 days prior to the cohort entry date
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
65 Years
Study:
NCT04736693
Study Brief:
Protocol Section:
NCT04736693