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)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Time to healing assessed by radiographic evidence
研究概览
简要总结
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.
详细描述
Patients will undergo screening assessment to determine the eligibility for study participation and will be randomized in 1:1 ratio to receive Teriparatide 20 μg or placebo subcutaneous once daily for 12 weeks.
All patients will receive supplements of 1000 mg/day of elemental calcium and 20,000 IU/week of vitamin D2.
Patients will be scheduled to clinic visit for radiographic and clinical assessment at 2, 6,12 and 24 weeks postoperatively. Each participant will be in the study for 6 months in total.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double blind, placebo-controlled
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
- •Severe renal impairment (CrCL < 30 mL/min)
- •Current treatment with digoxin and necessary to continue use during the study
- •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)
- •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.
- •Previous treatment with teriparatide, PTH or other PTH analogs, or prior participation in any other clinical trial studying teriparatide, PTH or other PTH analogs
研究组 & 干预措施
Placebo
Placebo subcutaneous once daily for 12 weeks
干预措施: Placebo (Drug)
Teriparatide
Teriparatide 20 μg subcutaneous once daily for 12 weeks
干预措施: Teriparatide (Drug)
Teriparatide
Teriparatide 20 μg subcutaneous once daily for 12 weeks
干预措施: Calcium supplement (Dietary Supplement)
Teriparatide
Teriparatide 20 μg subcutaneous once daily for 12 weeks
干预措施: Vitamin D (Dietary Supplement)
Placebo
Placebo subcutaneous once daily for 12 weeks
干预措施: Calcium supplement (Dietary Supplement)
Placebo
Placebo subcutaneous once daily for 12 weeks
干预措施: Vitamin D (Dietary Supplement)
结局指标
主要结局
Time to healing assessed by radiographic evidence
时间窗: from randomization, assessed up to 24 months
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)
次要结局
- Clinical evidence of healing assessed by weight bearing ability as one of functional outcomes(from randomization, assessed up to 24 months)
- Clinical evidence of healing assessed by Harris Hip Score as one of functional outcomes(from randomization, assessed up to 24 months)
- Clinical evidence of healing assessed by walking ability as one of functional outcomes(from randomization, assessed up to 24 months)
研究者
Prof.Dr.Aree Tanavalee, M.D.
Prof. Dr., M.D.
King Chulalongkorn Memorial Hospital