Effect of Teriparatide on Femoral Neck Fracture Healing
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture
研究概览
简要总结
The purpose of this study is to see whether teriparatide, given for 6 months versus placebo, will improve the healing of hip (femoral neck) fractures that are repaired during surgery using certain types of orthopedic screws. The study will enroll men and postmenopausal women at least 50 years of age with a recent hip (femoral neck) fracture caused by low-trauma (for example, fall from standing height or less).
详细描述
This is a 12-month, Phase 3, prospective, randomized, parallel, double-blind, placebo-controlled, multicenter, multinational study to evaluate the effect of 6 months of treatment with teriparatide on fracture healing in participants who have sustained a recent low-trauma, unilateral, femoral neck fracture stabilized by internal fixation. The study has 3 periods:
- A screening period that must be completed in ≤ 14 days after operative treatment of the femoral neck fracture
- A 6-month double-blind treatment period [teriparatide 20 µg or placebo given once daily by SC injection]
- A 6-month observation period.
The primary objective is to assess the effect of 6 months of treatment with teriparatide 20 µg/day versus placebo on the proportion of men and postmenopausal women of at least 50 years of age with no revision surgery 12 months after internal fixation of a low-trauma femoral neck fracture.
All participants will receive supplements of calcium and vitamin D beginning at screening and continuing for 12 months.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Community dwelling men and postmenopausal women who were ambulatory before sustaining a low-trauma, unilateral femoral neck fracture (displaced or nondisplaced)
- •Other than femoral neck fracture, be free of incapacitating conditions and have a life expectancy of at least 2 years
- •Have received or are eligible for treatment with internal fixation (sliding hip screw or multiple cancellous screws) for the femoral neck fracture (the surgical procedure itself is not performed as part of this study)
- •Have given written informed consent (participant or proxy) after being informed of the risks, medications, and study procedures
排除标准
- •Increased baseline risk of osteosarcoma
- •History of unresolved skeletal diseases affecting bone metabolism other than primary osteoporosis
- •Abnormally elevated serum calcium at screening
- •Abnormally elevated serum intact parathyroid hormone (PTH) (1-84) at screening
- •Severe vitamin D deficiency at screening
- •Active liver disease or jaundice
- •Significantly impaired renal function
- •Abnormal thyroid function not corrected by therapy
- •History of malignant neoplasm in the 5 years prior to screening
- •History of bone marrow or solid organ transplantation
- •History of symptomatic nephrolithiasis or urolithiasis in the 1 year prior to screening
- •Previous treatment with the following bone active drugs is allowed but must be discontinued at screening: oral bisphosphonates, selective estrogen receptor modulators (SERMs), calcitonin, estrogen (oral, transdermal, or injectable), progestin, estrogen analog, estrogen agonist, estrogen antagonist or tibolone, and active vitamin D3 analogs. Androgen or other anabolic steroid use must be discontinued, except for use of physiologic replacement testosterone
- •Previous treatment with the following bone active drugs is exclusionary, if the stated treatment durations have been met: strontium ranelate for any duration, intravenous bisphosphonates in the 12 months preceding screening, and/or denosumab in the 6 months preceding screening
- •Prior treatment with PTH, teriparatide, or other PTH analogs, or prior participation in any other clinical trial studying PTH, teriparatide, or other PTH analogs
- •Local or systemic treatment with bone morphogenic proteins or any other growth factor
- •Previous fracture(s) or bone surgery in the currently fractured hip
- •Soft-tissue infection at the operation site
- •Treatment with bone grafting or osteotomies
- •Treatment with augmentation using any type of degradable cement, hydroxyapatite-coated implants, or with noninvasive interventions
- •Associated major injuries of a lower extremity including fractures of the foot, ankle, tibia, fibula, knee, femur, femoral head or pelvis; dislocations of the ankle, knee or hip
研究组 & 干预措施
Placebo
Administered once daily by subcutaneous (SC) injection for 6 months
干预措施: Placebo (Drug)
Placebo
Administered once daily by subcutaneous (SC) injection for 6 months
干预措施: Calcium supplementation (Dietary Supplement)
Placebo
Administered once daily by subcutaneous (SC) injection for 6 months
干预措施: Vitamin D supplementation (Dietary Supplement)
Teriparatide
20 microgram (µg) administered once daily by SC injection for 6 months
干预措施: Teriparatide (Drug)
Teriparatide
20 microgram (µg) administered once daily by SC injection for 6 months
干预措施: Calcium supplementation (Dietary Supplement)
Teriparatide
20 microgram (µg) administered once daily by SC injection for 6 months
干预措施: Vitamin D supplementation (Dietary Supplement)
结局指标
主要结局
Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture
时间窗: 12 months
Revision surgery (re-operation) was defined as any additional surgical intervention performed or recommended at the site of the index procedure, except those that were planned at the time of the index procedure.
次要结局
- Percentage of Participants With Radiographic Evidence of Healing(Randomization up to 12 months)
- Percentage of Participants With Pain Control During Ambulation(Up to 12 months)
- Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit(Up to 12 months)
- Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing(Up to 12 months)
- Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain(Baseline, 6 Months)
- Mean Change From Baseline to 6 Months in Gait Speed(Baseline, up to 6 Months)
- Percentage of Participants With Functional Evidence of Healing(12 Months)
- Percentage of Participants Able to Ambulate(Up to 12 months)
- Percentage of Participants Who Regain Their Prefracture Ambulatory Status(Up to 12 months)
- Time to Revision Surgery(Baseline to revision surgery (up to 14.14 Months))
- Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores(Baseline, up to 6 Months)
- Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC)(Baseline, up to 6 Months)
- Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Health State Score(Baseline, up to 6 Months)