Unstable Intertrochanteric Fracture Clinical Trial
Official title:
A Phase III, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Effect of Teriparatide on Bone Union in Unstable Intertrochanteric Fracture Patients Treated With Proximal Femoral Nail Antirotation (PFNA)
Phase III, prospective, randomized, parallel, double blind, placebo-controlled study to determine whether Teriparatide can accelerate bone healing in unstable intertrochanteric fracture patients treated with Proximal Femoral Nail Antirotation (PFNA) assessed by radiographic and clinical outcomes.
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | March 1, 2022 |
| Est. primary completion date | December 1, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 50 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Thailand | Faculty of Medicine Chulalongkorn University | Bangkok |
| Lead Sponsor | Collaborator |
|---|---|
| King Chulalongkorn Memorial Hospital |
Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to healing assessed by radiographic evidence | Fracture is judged to be healed radiographically if bridging callus was evident on 3 of 4 cortices as seen on two views (cortical bridging of three cortices) | from randomization, assessed up to 24 months | |
| Secondary | Clinical evidence of healing assessed by Harris Hip Score as one of functional outcomes | Harris Hip Score (90-100: Excellent, 80-89: Good, 70-79: Fair, <70 poor) | from randomization, assessed up to 24 months | |
| Secondary | Clinical evidence of healing assessed by weight bearing ability as one of functional outcomes | Weight bearing ability (Non weight bearing, Partial weight bearing, Full weight bearing) | from randomization, assessed up to 24 months | |
| Secondary | Clinical evidence of healing assessed by walking ability as one of functional outcomes | Walking ability (Independent walking, Assisted walking, Bedridden) | from randomization, assessed up to 24 months |