Effect of Teriparatide on Hip Fracture Healing
2015年4月10日 更新者：Eli Lilly and Company
Effect of Teriparatide on Femoral Neck Fracture Healing
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).
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
122
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Aarhus、丹麦、8000
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Hillerod、丹麦、Dk-3400
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Kobenhavn、丹麦、2400
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Koege、丹麦、4600
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Haifa、以色列、31096
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Jerusalem、以色列、91240
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Ontario
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Newmarket、Ontario、加拿大、L3Y 2P9
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St. Catharines、Ontario、加拿大、L2R 5J7
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Quebec
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St-Jerome、Quebec、加拿大、J7Z 5T3
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Ahmedabad、印度、532004
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Attavar, Mangalore、印度、575001
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Bangalore、印度、560 054
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Hyderabaad、印度、500033
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Nagpur、印度、444001
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Vadodara、印度、390018
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Jhonghe City、台湾、235
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Kaohsiung、台湾、824
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Taichung、台湾、40705
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Taichung City、台湾、40201
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Taipei、台湾、220
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Seongnam-Si、大韩民国、463-707
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Seoul、大韩民国、135 720
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Riga、拉脱维亚、1005
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Toensberg、挪威、NO-3103
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Christchurch、新西兰、8022
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Takapuna、新西兰、0622
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Wellington South、新西兰、6021
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Aichi、日本、465-8620
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Chiba、日本、275-8580
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Fukuoka、日本、831-0016
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Fukushima、日本、961
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Gunma、日本、371-0014
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Hiroshima、日本、739-0696
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Ibaraki、日本、305-0854
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Japan、日本、399-8292
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Kagawa、日本、765-8507
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Nagano、日本、390-8510
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Niigata、日本、950-1197
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Ohita、日本、874-0011
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Osaka、日本、586-8521
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Saga、日本、840
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Shimane、日本、697-8511
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Shizuoka、日本、411-8611
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Toyama、日本、939-1395
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Toyko、日本、208-0011
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Yamaguchi、日本、754-0002
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Yamanashi、日本、400-8506
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San Juan、波多黎各、00936-5067
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New South Wales
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Penrith、New South Wales、澳大利亚、2751
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Victoria
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Heidelberg、Victoria、澳大利亚、3081
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St Albans、Victoria、澳大利亚、3021
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Western Australia
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Nedlands、Western Australia、澳大利亚、6009
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Tartu、爱沙尼亚、51014
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Malmo、瑞典、205 02
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Mölndal、瑞典、43180
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Stockholm、瑞典、SE-118 83
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Kaunas、立陶宛、44320
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Klaipeda、立陶宛、92228
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Vilnius、立陶宛、04130
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Arizona
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Phoenix、Arizona、美国、85027
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Tucson、Arizona、美国、85712
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California
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La Mesa、California、美国、91942
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Laguna Hills、California、美国、92653
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Lancaster、California、美国、93534
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Pasadena、California、美国、91101
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Connecticut
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Danbury、Connecticut、美国、06810
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Florida
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Boca Raton、Florida、美国、33486
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Bradenton、Florida、美国、34209
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Miami、Florida、美国、33136
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Orlando、Florida、美国、32804
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Idaho
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Idaho Falls、Idaho、美国、83404
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Michigan
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Royal Oak、Michigan、美国、48073
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Missouri
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Columbia、Missouri、美国、65212
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Springfield、Missouri、美国、65804
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Montana
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Billings、Montana、美国、59101
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Great Falls、Montana、美国、59405
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Nebraska
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Omaha、Nebraska、美国、68131
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North Carolina
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Asheville、North Carolina、美国、28801
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North Dakota
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Fargo、North Dakota、美国、58103
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Pennsylvania
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York、Pennsylvania、美国、17405
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Texas
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Houston、Texas、美国、77043
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San Antonio、Texas、美国、78229
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Utah
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Salt Lake City、Utah、美国、84108
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Oulu、芬兰、90229
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Turku、芬兰、SF-20520
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Alcira、西班牙、46600
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Barcelona、西班牙、08025
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Girona、西班牙、17007
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Guadalajara、西班牙、19002
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Marbella、西班牙、29600
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pozuelo De Alarcon、西班牙、28223
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hong Kong、香港
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
50年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：安慰剂
通过皮下 (SC) 注射每天一次，持续 6 个月
|
SC注射给药
口服给药
口服给药
|
|
实验性的：特立帕肽
20 微克 (µg) 每天一次通过 SC 注射给药，持续 6 个月
|
口服给药
口服给药
SC注射给药
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
低创伤性股骨颈骨折内固定后 12 个月未进行翻修手术的参与者百分比
大体时间：12个月
|
翻修手术（再手术）定义为在指标手术部位进行或推荐的任何额外手术干预，但在指标手术时计划进行的手术除外。
|
12个月
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of Participants With Radiographic Evidence of Healing
大体时间：Randomization up to 12 months
|
The signs of femoral neck fracture healing included disappearance of the fracture line on radiographs. If a participant had radiographic evidence of healing at the 12-month visit, that participant was considered to have radiographic evidence of healing. Percentage was calculated as: (number of participants with radiographic evidence of healing / total number of participants analyzed) * 100. |
Randomization up to 12 months
|
|
Percentage of Participants With Pain Control During Ambulation
大体时间：Up to 12 months
|
The worst pain numeric rating scale (NRS) was used to assess the impact of pain on a participant's life.
NRS Item 3 assessed the worst musculoskeletal pain severity during the walking test.
Pain was measured by an 11-point Likert scale.
The following cut-points were used to categorize the NRS responses: 0 = no pain, 1 to 4 = mild pain, 5 to 6 = moderate pain, and 7 to 10 = severe pain.
Participants with an NRS score of <7 were categorized as having no severe fracture-site pain with ambulation and no worsening of NRS scores >2 from baseline.
Percentage was calculated as: (Number of participants with pain control during ambulation / total number of participants) * 100.
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Up to 12 months
|
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Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit
大体时间：Up to 12 months
|
The worst pain NRS was used to assess the impact of pain on a participant's life.
Fracture-site pain severity was assessed for pain in the 24 hours preceding a visit.
Pain was measured by an 11-point Likert scale.
Participants with an NRS score of <7 in the 24 hours preceding a visit and no worsening of NRS >2 from baseline were categorized as having no severe fracture-site pain.
Percentage was calculated as: (number of participants with pain control during 24 hours preceding a visit / total number of participants) * 100.
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Up to 12 months
|
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Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing
大体时间：Up to 12 months
|
The worst pain NRS was used to assess the impact of pain on a participant's life.
Fracture-site pain severity was assessed for pain on weight bearing.
Pain was measured by an 11-point Likert scale.
Participants with an NRS score of <7 during weight bearing and no worsening of NRS >2 from baseline were categorized as having no severe fracture-site pain.
Percentage was calculated as: (number of participants with pain control during weight bearing / total number of participants) * 100.
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Up to 12 months
|
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Percentage of Participants With Functional Evidence of Healing
大体时间：12 Months
|
Functional healing was defined as ability to walk with a gait speed ≥ 0.05 meters/second (m/s) with a change from baseline ≥ -0.1 m/s. The walking test involved having the participant walk a distance of 7 meters (m) at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant's gait speed in m/s. Percentage was calculated as: (number of participants with functional evidence of healing / total number of participants analyzed) * 100. |
12 Months
|
|
Percentage of Participants Able to Ambulate
大体时间：Up to 12 months
|
Ability to ambulate was defined as ambulatory with convalescent aid or without convalescent aid.
Percentage was calculated as: (number of participants able to ambulate / number of total participants analyzed) * 100.
|
Up to 12 months
|
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Percentage of Participants Who Regain Their Prefracture Ambulatory Status
大体时间：Up to 12 months
|
Prefracture ambulatory status was defined as either ambulatory with or without a walking aid.
A participant was considered to have regained their prefracture ambulatory status if the participant's postsurgery ambulatory status was returned to or was improved from their pre-surgery ambulatory status.
Percentage was calculated as = (number of participants who regained their ambulatory status / total number analyzed) * 100.
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Up to 12 months
|
|
Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain
大体时间：Baseline, 6 Months
|
The worst pain NRS was used to assess the impact of pain on a participant's life.
Participants with an NRS score of <7 were categorized as having no severe fracture-site pain.
Least Squares (LS) means was calculated using analysis of covariance (ANCOVA) and adjusted for baseline, treatment group, region, fracture type, and fixation type.
|
Baseline, 6 Months
|
|
Mean Change From Baseline to 6 Months in Gait Speed
大体时间：Baseline, up to 6 Months
|
The walking test involved having the participant walk a distance of 7 m at a self-selected, comfortable pace.
A 4-m portion of the test was timed to determine the participant's gait speed in m/s.
LS means was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, and fixation type.
|
Baseline, up to 6 Months
|
|
Time to Revision Surgery
大体时间：Baseline to revision surgery (up to 14.14 Months)
|
Time to revision surgery was defined as the time from initial hip fracture surgery to revision surgery, or recommendation for revision surgery if recommended but not performed.
Time to revision surgery was censored at the date of the last contact.
|
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
大体时间：Baseline, up to 6 Months
|
SF-12 is a self-reported questionnaire covering a mental component score (MCS) and a physical component score (PCS), each scoring from a 0 to 100 (worst to best) scale.
LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.
|
Baseline, up to 6 Months
|
|
Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC)
大体时间：Baseline, up to 6 Months
|
WOMAC is: a self-reported questionnaire that consisted of 24 questions covering 3 health domains: Pain (5 items: during walking, using stairs, in bed, sitting or lying, and standing), Stiffness (2 items: after first waking and later in the day), and Physical Function.
Each domain was scored by summing the individual items and transforming the scores into a 0 to 100 (best to worst) scale.
LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.
|
Baseline, up to 6 Months
|
|
Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Health State Score
大体时间：Baseline, up to 6 Months
|
The EQ-5D is a 5-item, self-reported, generic, multidimensional, health-related, quality-of-life instrument with 5 items.
Overall health state score was also self-reported using a visual analogue scale (VAS) marked on a scale scored from 0 (worse imaginable health state) to 100 (best imaginable health state).
LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, and region.
|
Baseline, up to 6 Months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年2月1日
初级完成 (实际的)
2013年12月1日
研究完成 (实际的)
2013年12月1日
研究注册日期
首次提交
2011年11月14日
首先提交符合 QC 标准的
2011年11月14日
首次发布 (估计)
2011年11月17日
研究记录更新
最后更新发布 (估计)
2015年4月16日
上次提交的符合 QC 标准的更新
2015年4月10日
最后验证
2015年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.