CompletedPhase 3

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

Thailand50 participantsStarted 2017-05-17

Plain-language 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.

Who can participate

Age range50 Years

SexALL

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Inclusion criteria

✓. Male and female patient, age ≥ 50 years at the time of screening
✓. Unstable intertrochanteric fracture (AO/OTA 31-A2 and 31-A3)
✓. Treated by proximal femoral nail antirotation (PFNA)

Exclusion criteria

✕. Known hypersentivity to teriparatide or any form of PTH or analogue
✕. Metabolic bone disease other than primary osteoporosis (including Hyper Parathyroidism and Paget's disease of bone)
✕. Increased baseline risk of osteosarcoma (Paget's disease of the bone, previous primary skeletal malignancy, or skeletal exposure to therapeutic irradiation)
✕. 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.
✕. Pre-existing of hypercalcemia (total serum calcium \>10.5 mg/dL or 2.6 mmol/L)
✕. Abnormally elevated serum intact parathyroid hormone at screening (serum PTH \> 70 pg/mL)
✕. Severe vitamin D deficiency (25-hydroxyvitamin D \< 12 ng/mL)
✕. Unexplained elevations of alkaline phosphatase (ALP \> 120 UL)

What they're measuring

Time to healing assessed by radiographic evidence

Timeframe: from randomization, assessed up to 24 months

Trial details

NCT IDNCT03133195

SponsorKing Chulalongkorn Memorial Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-01

View on ClinicalTrials.gov More Unstable Intertrochanteric Fracture trials