Phase 3 Clinical Trial of Teriparatide in Japan
2010년 9월 14일 업데이트: Eli Lilly and Company
Efficacy and Safety of LY333334 in Japanese Patients With Osteoporosis
To evaluate the efficacy of teriparatide based on measurements of bone mineral density at lumbar spine
연구 개요
연구 유형
중재적
등록 (실제)
207
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Aichi, 일본, 454-0933
- 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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Fukuoka, 일본, 811-2101
- 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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Hokkaido, 일본, 070-0034
- 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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Hyogo, 일본, 655-0853
- 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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Iwate, 일본, 020-8505
- 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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Kagoshima, 일본, 890-0014
- 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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Kanagawa, 일본, 231-0023
- 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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Nagano, 일본, 386-0493
- 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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Nagasaki, 일본, 854-0083
- 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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Oita, 일본, 879-7125
- 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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Osaka, 일본, 555-0032
- 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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Saitama, 일본, 358-0007
- 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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Shimane, 일본, 693-0021
- 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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Tokushima, 일본, 770-8503
- 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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Tokyo, 일본, 163-0202
- 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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Tottori, 일본, 683-0853
- 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
55년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Japanese patients diagnosed with osteoporosis
- Aged 55 or older
- Patients who are at high risk for fracture
Exclusion Criteria:
- History of metabolic bone disorders other than primary osteoporosis
- History of malignant neoplasm in the 5 years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated.
- Severe or chronically disabling conditions other than osteoporosis
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: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Teriparatide
20 micrograms for 104 weeks
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daily, subcutaneous
다른 이름들:
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위약 비교기: Placebo
Placebo for 52 weeks.
After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
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daily, subcutaneous
다른 이름들:
daily, subcutaneous
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4)
기간: Baseline to 52 weeks
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Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.
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Baseline to 52 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4)
기간: Baseline to 52 Weeks
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Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.
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Baseline to 52 Weeks
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Percent Change in Bone Mineral Density (BMD) at Total Hip
기간: Baseline to 52 Weeks
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Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.
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Baseline to 52 Weeks
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Percent Change in Bone Mineral Density (BMD) at Femoral Neck
기간: Baseline to 52 Weeks
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Percent change in bone mineral density at femoral neck from baseline to the last measurement point.
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Baseline to 52 Weeks
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Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP)
기간: Baseline to Weeks 4, 12, 24, and 52
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Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.
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Baseline to Weeks 4, 12, 24, and 52
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Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP)
기간: Baseline to Weeks 4, 12, 24, 52
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Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.
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Baseline to Weeks 4, 12, 24, 52
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Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX)
기간: Baseline to Weeks 4, 12, 24, 52
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Percent change in serum type I collagen crosslinked C-telopeptide (CTX) from baseline to the individual visits and last measurement point.
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Baseline to Weeks 4, 12, 24, 52
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Vertebral Fractures by Central X-ray Assessment
기간: Baseline through 52 weeks
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Number of vertebral fractures observed from Visit 1 (study entry) through Visit 19 (Week 52).
All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment.
Number of subjects with fractures and number of fractured vertebra(e) were counted.
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Baseline through 52 weeks
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Fractures by Investigators Assessment
기간: Baseline through 52 Weeks
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Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment.
Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident.
Fractures were assessed to be "fragility" if they occurred without trauma.
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Baseline through 52 Weeks
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Back Pain Severity
기간: Baseline, Weeks 12, 24, 36, 52
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Severity of back pain at baseline, individual visits and the last measurement point.
Back pain was measured on a scale of 1 (none) to 4 (severe).
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Baseline, Weeks 12, 24, 36, 52
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Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) During Open Label Phases at 76 Weeks and 104 Weeks
기간: Baseline, 76 Weeks, 104 Weeks
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Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.
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Baseline, 76 Weeks, 104 Weeks
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Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) During Open Label Phases at 76 Weeks and 104 Weeks
기간: Baseline, 76 Weeks, 104 Weeks
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Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.
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Baseline, 76 Weeks, 104 Weeks
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Percent Change in Bone Mineral Density (BMD) at Total Hip During Open Label Phases at 76 Weeks and 104 Weeks
기간: Baseline, 76 Weeks, 104 Weeks
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Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.
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Baseline, 76 Weeks, 104 Weeks
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Percent Change in Bone Mineral Density (BMD) at Femoral Neck During Open Label Phases at 76 Weeks and 104 Weeks
기간: Baseline, 76 Weeks, 104 Weeks
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Percent change in bone mineral density at femoral neck from baseline to the last measurement point.
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Baseline, 76 Weeks, 104 Weeks
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Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) During Open Label Phases at 76 Weeks and 104 Weeks
기간: Baseline, 76 Weeks, 104 Weeks
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Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.
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Baseline, 76 Weeks, 104 Weeks
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Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) During Open Label Phases at 76 Weeks and 104 Weeks
기간: Baseline, 76 Weeks, 104 Weeks
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Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.
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Baseline, 76 Weeks, 104 Weeks
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Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) During Open Label Phases at 76 Weeks and 104 Weeks
기간: Baseline, 76 Weeks, 104 Weeks
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Percent change in serum type I collagen crosslinked C-telepeptide (CTX) from baseline to the individual visits and last measurement point.
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Baseline, 76 Weeks, 104 Weeks
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Vertebral Fractures by Central X-ray Assessment During Entire Study Period of 104 Weeks
기간: Baseline through 104 Weeks
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Number of vertebral fractures observed from Visit 1 (study entry) through 104 weeks.
All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment.
Number of subjects with fractures and number of fractured vertebra(e) were counted.
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Baseline through 104 Weeks
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Fractures by Investigators Assessment During Entire Study Period of 104 Weeks
기간: Baseline Through 104 Weeks
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Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment.
Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident.
Fractures were assessed to be "fragility" if they occurred without trauma.
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Baseline Through 104 Weeks
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Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks
기간: Baseline, 76 Weeks, 104 Weeks
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Severity of back pain at 76 weeks and 104 weeks.
Back pain was measured on a scale of 1 (none) to 4 (severe).
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Baseline, 76 Weeks, 104 Weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Miyauchi A, Matsumoto T, Sugimoto T, Tsujimoto M, Warner MR, Nakamura T. Effects of teriparatide on bone mineral density and bone turnover markers in Japanese subjects with osteoporosis at high risk of fracture in a 24-month clinical study: 12-month, randomized, placebo-controlled, double-blind and 12-month open-label phases. Bone. 2010 Sep;47(3):493-502. doi: 10.1016/j.bone.2010.05.022. Epub 2010 May 24.
- Yamamoto T, Tsujimoto M, Sowa H. Safety of daily teriparatide treatment: a post hoc analysis of a Phase III study to investigate the possible association of teriparatide treatment with calcium homeostasis in patients with serum procollagen type I N-terminal propeptide elevation. Clin Interv Aging. 2015 Jul 6;10:1101-9. doi: 10.2147/CIA.S83549. eCollection 2015.
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
2007년 1월 1일
기본 완료 (실제)
2008년 9월 1일
연구 완료 (실제)
2009년 9월 1일
연구 등록 날짜
최초 제출
2007년 2월 7일
QC 기준을 충족하는 최초 제출
2007년 2월 7일
처음 게시됨 (추정)
2007년 2월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2010년 9월 21일
QC 기준을 충족하는 마지막 업데이트 제출
2010년 9월 14일
마지막으로 확인됨
2010년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 10494
- B3D-JE-GHDB (기타 식별자: Eli Lilly and Company)
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. .