The Effect of Teriparatide on Bone Union in Unstable Intertrochanteric Fracture Patients Treated With PFNA

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: King Chulalongkorn Memorial Hospital
• Treatments: Calcium; Parathyroid Hormone; Teriparatide; Vitamin D; Vitamins

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