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 @ 9:36 PM
Ignite Modification Date:
2025-12-24 @ 9:36 PM
NCT ID:
NCT04249232
Eligibility Criteria:
Inclusion Criteria:
* Postmenopausal women and men \>50 years of age with acute pelvic fractures, occurring with minimal trauma, presenting to Mount Sinai, New York University, New York Presbyterian-Queens, Hospital for Special Surgery, or New York Hospital (Cornell Medical) within one month of the onset of symptoms.
Exclusion Criteria:
1. Persons unable to complete the NRS and other surveys based on assessment by the study doctor.
2. Previously (prior to fracture) non-ambulatory subjects
3. Exclusion criteria related to contraindication or intolerance to ABALOPARATIDE:
1. Hypersensitivity to ABALOPARATIDE
2. Patients with increased risk of osteosarcoma: Paget's disease, history of radiation treatment
3. Patients with active hypercalcemia based on serum calcium above the upper limit of normal.
4. Serum creatinine cannot be elevated more than 1.5 times above upper normal limit for age
5. Current diagnosis of hyperparathyroidism and other metabolic bone disease including osteogenesis imperfecta
6. Multiple Kidney stones (calcium oxalate) within the last 10 years or single kidney stone (calcium oxalate) within the last year. If stone type is not known, a 24-hour urine calcium determination can be performed; if not elevated, the patient does not require exclusion.
7. Normal alkaline phosphatase levels will not be used as an entrance criterion because most fracture patients will have elevations due to the acute fracture. However, we will attempt to obtain lab tests from the period prior to fracture to determine if they were normal. If unexplained elevations in alkaline phosphatase (more than 1.5 times above the upper limit of normal) are found in labs prior to the fracture, we will exclude that subject.
8. Diagnosis of metastatic cancer within the past 10 years; primary bone cancer or multiple myeloma at any time. For other primary active non-skin cancers (diagnosed within the last 5 years), the patient's oncologist should be consulted to determine participant eligibility.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT04249232
Study Brief:
Protocol Section:
NCT04249232