Effect of Teriparatide on Hip Fracture Healing
2015년 4월 10일 업데이트: 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).
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
122
단계
- 3단계
연락처 및 위치
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Toensberg, 노르웨이, NO-3103
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Arizona
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Connecticut
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Idaho
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Idaho Falls, Idaho, 미국, 83404
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Michigan
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Royal Oak, Michigan, 미국, 48073
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Montana
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Nebraska
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Omaha, Nebraska, 미국, 68131
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North Carolina
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North Dakota
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Pennsylvania
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Texas
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Ahmedabad, 인도, 532004
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Aichi, 일본, 465-8620
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Chiba, 일본, 275-8580
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Fukushima, 일본, 961
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Gunma, 일본, 371-0014
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Hiroshima, 일본, 739-0696
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Ibaraki, 일본, 305-0854
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Japan, 일본, 399-8292
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Kagawa, 일본, 765-8507
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Nagano, 일본, 390-8510
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Niigata, 일본, 950-1197
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Ohita, 일본, 874-0011
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Osaka, 일본, 586-8521
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Saga, 일본, 840
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Shimane, 일본, 697-8511
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Shizuoka, 일본, 411-8611
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Toyama, 일본, 939-1395
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Toyko, 일본, 208-0011
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Yamaguchi, 일본, 754-0002
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Yamanashi, 일본, 400-8506
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Ontario
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Newmarket, Ontario, 캐나다, L3Y 2P9
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St. Catharines, Ontario, 캐나다, L2R 5J7
- 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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Quebec
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St-Jerome, Quebec, 캐나다, J7Z 5T3
- 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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San Juan, 푸에르토 리코, 00936-5067
- 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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Oulu, 핀란드, 90229
- 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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Turku, 핀란드, SF-20520
- 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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New South Wales
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Penrith, New South Wales, 호주, 2751
- 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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Victoria
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Heidelberg, Victoria, 호주, 3081
- 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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St Albans, Victoria, 호주, 3021
- 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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Western Australia
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Nedlands, Western Australia, 호주, 6009
- 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, 홍콩
- 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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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
50년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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위약 비교기: 위약
6개월 동안 1일 1회 피하(SC) 주사로 투여
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SC 주입으로 관리
구두로 관리
구두로 관리
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실험적: 테리파라타이드
6개월 동안 1일 1회 SC 주사로 20마이크로그램(µg) 투여
|
구두로 관리
구두로 관리
SC 주입으로 관리
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
저외상 대퇴골 경부 골절의 내부 고정 후 12개월에 재수술을 받지 않은 참가자 비율
기간: 12 개월
|
재수술(재수술)은 인덱스 시술 시 계획된 수술을 제외하고 인덱스 시술 부위에서 수행되거나 권장되는 추가 수술 개입으로 정의되었습니다.
|
12 개월
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of Participants With Radiographic Evidence of Healing
기간: 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
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Percentage of Participants With Pain Control During Ambulation
기간: Up to 12 months
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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
기간: 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
기간: 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
기간: 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
|
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Percentage of Participants Able to Ambulate
기간: 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.
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Up to 12 months
|
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Percentage of Participants Who Regain Their Prefracture Ambulatory Status
기간: 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
|
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Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain
기간: 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
|
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Mean Change From Baseline to 6 Months in Gait Speed
기간: 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
|
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Time to Revision Surgery
기간: 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
기간: 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)
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2012년 2월 1일
기본 완료 (실제)
2013년 12월 1일
연구 완료 (실제)
2013년 12월 1일
연구 등록 날짜
최초 제출
2011년 11월 14일
QC 기준을 충족하는 최초 제출
2011년 11월 14일
처음 게시됨 (추정)
2011년 11월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 4월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 4월 10일
마지막으로 확인됨
2015년 4월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
위약에 대한 임상 시험
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Newish Biotech (Wuxi) Co., Ltd.아직 모집하지 않음
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Chiesi Farmaceutici S.p.A.아직 모집하지 않음
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Nature's Sunshine Products, Inc.아직 모집하지 않음
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University of Texas Southwestern Medical Center아직 모집하지 않음
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Universidad Autonoma de Zacatecas모집하지 않고 적극적으로
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Vertex Pharmaceuticals Incorporated모병
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Enanta Pharmaceuticals, Inc아직 모집하지 않음호흡기 세포융합 바이러스(RSV) | RSV 감염 | RSV
-
Universidad Autonoma de Nuevo Leon완전한