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 @ 2:15 PM
Ignite Modification Date:
2025-12-24 @ 2:15 PM
NCT ID:
NCT03133195
Eligibility Criteria:
Inclusion Criteria:
1. Male and female patient, age ≥ 50 years at the time of screening
2. Unstable intertrochanteric fracture (AO/OTA 31-A2 and 31-A3)
3. Treated by proximal femoral nail antirotation (PFNA)
Exclusion Criteria:
1. Known hypersentivity to teriparatide or any form of PTH or analogue
2. Metabolic bone disease other than primary osteoporosis (including Hyper Parathyroidism and Paget's disease of bone)
3. Increased baseline risk of osteosarcoma (Paget's disease of the bone, previous primary skeletal malignancy, or skeletal exposure to therapeutic irradiation)
4. History of malignant neoplasm in the 5 years prior to the study (with the exception of superficial basal cell carcinoma or squamous cell carcinoma) and carcinoma in situ of the uterine cervix treated less than 1 year prior to the study.
5. Pre-existing of hypercalcemia (total serum calcium \>10.5 mg/dL or 2.6 mmol/L)
6. Abnormally elevated serum intact parathyroid hormone at screening (serum PTH \> 70 pg/mL)
7. Severe vitamin D deficiency (25-hydroxyvitamin D \< 12 ng/mL)
8. Unexplained elevations of alkaline phosphatase (ALP \> 120 UL)
9. Severe renal impairment (CrCL \< 30 mL/min)
10. Current treatment with digoxin and necessary to continue use during the study
11. Concurrent treatment with oral bisphosphonates, selective estrogen receptor modulator (SERMs), calcitonin, estrogen (oral, transdermal, or injection), progestin, estrogen analog, estrogen agonist, estrogen antagonist or tibolone, and active vitamin D3 analogs. (Previous treatment is allowed but must be discontinued at screening)
12. Previous treatment with strontium ranelate for any duration, intravenous bisphophonates within 12 months prior to the screening date, and/or denosumab within 6 months prior to the screening.
13. Previous treatment with teriparatide, PTH or other PTH analogs, or prior participation in any other clinical trial studying teriparatide, PTH or other PTH analogs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT03133195
Study Brief:
Protocol Section:
NCT03133195