Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis
2009년 2월 13일 업데이트: Eli Lilly and Company
Comparison of the Effects of Teriparatide With Those of Alendronate Sodium on Lumbar Spine Bone Mineral Density in Glucocorticoid-Induced Osteoporosis
Osteoporosis is a condition in which the amount of bone is reduced, the bones are weak, and there is an increased risk for fractures.
Glucocorticoids (such as prednisone) are prescribed to treat a large number of conditions such as arthritis and asthma.
When taken for several months or longer, glucocorticoids can cause bone loss and lead to a form of osteoporosis called "glucocorticoid-induced osteoporosis."
This study compared the effects of teriparatide, the study drug, with alendronate, an approved drug for treating glucocorticoid-induced osteoporosis.
연구 개요
연구 유형
중재적
등록 (실제)
428
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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Oslo, 노르웨이
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Aarhus, 덴마크
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California
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Loma Linda, California, 미국
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Palo Alto, California, 미국
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Colorado
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Aurora, Colorado, 미국
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North Dakota
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Fargo, North Dakota, 미국
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Jamestown, North Dakota, 미국
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Wisconsin
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Milwaukee, Wisconsin, 미국
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Brussels, 벨기에
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Gent, 벨기에
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Leuven, 벨기에
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Graz, 오스트리아
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Vienna, 오스트리아
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Carolina, 푸에르토 리코
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Ponce, 푸에르토 리코
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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
21년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Men or women age 21 years or older
- Taking on average 5.0 mg/day prednisone or equivalent for at least 3 months prior to screening
Exclusion Criteria:
- Taking bisphosphonates within past 6 months
- More than 30 micrograms/day of estradiol or equivalent in past 3 months
- History of alcoholism or drug abuse in past year
- Pregnant women or nursing mothers
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: A
Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
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20 micrograms/day, injection, 36 months
다른 이름들:
Oral placebo, daily, 36 months
Injection placebo, daily, 36 months
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활성 비교기: B
Alendronate 10 mg/day oral plus injection placebo, 36 months
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Oral placebo, daily, 36 months
Injection placebo, daily, 36 months
10 mg/day, oral, 36 months
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD)
기간: 18 month endpoint
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change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
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18 month endpoint
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset
기간: 18 month endpoint
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change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
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18 month endpoint
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Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined
기간: 3, 6, 12, 18, 24, 36 months
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change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
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3, 6, 12, 18, 24, 36 months
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Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset
기간: 3, 6, 12, and 18 months
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change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
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3, 6, 12, and 18 months
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Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined
기간: 24 and 36 months and Endpoint at 36 months
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change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
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24 and 36 months and Endpoint at 36 months
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Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined
기간: 18, 24, 36 months, and 18 and 36 month endpoints
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change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)
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18, 24, 36 months, and 18 and 36 month endpoints
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Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined
기간: 18, 24, 36 months, and 18 and 36 month endpoints
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change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)
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18, 24, 36 months, and 18 and 36 month endpoints
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Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined
기간: 12, 18, 24, and 36 months
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change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)
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12, 18, 24, and 36 months
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Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined
기간: 12, 18, 24, and 36 months
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change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)
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12, 18, 24, and 36 months
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Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen
기간: 1, 6, 18, and 36 months
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1, 6, 18, and 36 months
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Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen
기간: 1, 6, 18, and 36 months
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1, 6, 18, and 36 months
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Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase
기간: 1, 6, 18, and 36 months
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1, 6, 18, and 36 months
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Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments
기간: 1, 6, 18, and 36 months
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1, 6, 18, and 36 months
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Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin
기간: 1, 6, 18, and 36 months
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1, 6, 18, and 36 months
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Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures
기간: 36 months
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Clinical vertebral fracture was defined as a radiographically confirmed fracture that was associated with symptoms such as back pain.
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36 months
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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
- Saag KG, Agnusdei D, Hans D, Kohlmeier LA, Krohn KD, Leib ES, MacLaughlin EJ, Alam J, Simonelli C, Taylor KA, Marcus R. Trabecular Bone Score in Patients With Chronic Glucocorticoid Therapy-Induced Osteoporosis Treated With Alendronate or Teriparatide. Arthritis Rheumatol. 2016 Sep;68(9):2122-8. doi: 10.1002/art.39726.
- Devogelaer JP, Adler RA, Recknor C, See K, Warner MR, Wong M, Krohn K. Baseline glucocorticoid dose and bone mineral density response with teriparatide or alendronate therapy in patients with glucocorticoid-induced osteoporosis. J Rheumatol. 2010 Jan;37(1):141-8. doi: 10.3899/jrheum.090411. Epub 2009 Nov 16.
- Saag KG, Shane E, Boonen S, Marin F, Donley DW, Taylor KA, Dalsky GP, Marcus R. Teriparatide or alendronate in glucocorticoid-induced osteoporosis. N Engl J Med. 2007 Nov 15;357(20):2028-39. doi: 10.1056/NEJMoa071408.
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
2002년 11월 1일
기본 완료 (실제)
2006년 7월 1일
연구 완료 (실제)
2008년 1월 1일
연구 등록 날짜
최초 제출
2003년 1월 13일
QC 기준을 충족하는 최초 제출
2003년 1월 13일
처음 게시됨 (추정)
2003년 1월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2009년 3월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2009년 2월 13일
마지막으로 확인됨
2009년 2월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 6484
- B3D-US-GHBZ
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. .