Randomized Trial of Risedronate to Prevent Bone Loss in Renal Transplant Recipients.
2019년 2월 5일 업데이트: Montefiore Medical Center
Randomized Trial of Risedronate to Prevent Bone Loss in Renal Transplant
Patients with kidney failure have underlying bone disease at the time of transplant. Fractures of various bones can be as high as 22%. Medication required for the transplant plays a role in bone loss.
Bisphosphonates are used in the general population to treat bone loss of osteoporosis and steroid-induced bone loss. While previous studies, using various bisphosphonates, have shown preservation of bone mineral density in renal transplant recipients, we have demonstrated that pamidronate, a second generation bisphosphonate, is associated with low bone turnover while still preserving bone mineral density. Improved bone mineral density is associated with decreased fracture risk in the general population, while low bone turnover may be associated with increased fracture in dialysis patients.
The purpose of this study is to determine whether risedronate, a third generation bisphosphonate, is effective in preserving bone density when given prophylactically following renal transplantation and whether it is associated with low bone turnover at one year following renal transplantation.
연구 개요
상세 설명
Participants who receive a living donor kidney transplant undergo a bone biopsy at the time of kidney transplant and after one year of protocol.
Once adequate kidney function is established, both groups take by mouth a weekly capsule (the control group has a placebo; the treatment group has risedronate 35 mg).
Both groups undergo baseline, 6 month and 12 month dual energy x-ray absorptiometry (DEXA) bone mineral density scans.
Both groups undergo bone hormonal studies at regular intervals.
연구 유형
중재적
등록 (실제)
60
단계
- 2 단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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New York
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Bronx, New York, 미국, 10467
- Montefiore Medical Center
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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
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Adults with end stage renal disease who are undergoing living donor kidney transplantation
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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실험적: Risedronate
subjects received Risedronate for one year
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risedronate 35 mg weekly
다른 이름들:
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위약 비교기: subjects received placebo
subjects received placebo for 1 year
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Risedronate Placebo 35 mg weekly
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Bone Mineral Density of Spine at 6 Months
기간: month 6 of the treatment
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Bone Mineral Density (BMD) measurements were of the vertebral spine (L1-L4) measured using the Hologic 4500 QDC scanner.
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month 6 of the treatment
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Bone Mineral Density of Spine at 12 Months
기간: month 12 of treatment
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Bone Mineral Density (BMD) measurements were of the vertebral spine (L1-L4) measured using same Hologic 4500 QDC scanner.
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month 12 of treatment
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Bone Mineral Density of the Hip at 6 Months
기간: month 6 of the treatment
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Bone mineral density (BMD) of the total hip were measured using the Hologic 4500 QDC scanner.
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month 6 of the treatment
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Bone Mineral Density of the Hip at 12 Months
기간: month 12 of the treatment
|
Bone mineral density (BMD) of the total hip were measured using the Hologic 4500 QDC scanner.
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month 12 of the treatment
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Bone Mineral Density of Forearm at 6 Months
기간: month 6 of the treatment
|
Bone mineral density (BMD) of the distal third of the nondialysis access forearm were measured using the Hologic 4500 QDC scanner.
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month 6 of the treatment
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Bone Mineral Density of Forearm at 12 Months
기간: month 12 of the treatment
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Bone mineral density (BMD) of the distal third of the nondialysis access forearm were measured using the Hologic 4500 QDC scanner.
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month 12 of the treatment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Bone Histomorphometry - Percent Bone Volume (BV/TV)
기간: Baseline and month 12 of the treatment
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Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy.
Percent Bone Volume is the percentage of total volume occupied by calcified bone.
Percent Bone volume is calculated as Bone Volume (BV) divided by Tissue Volume (TV), where TV is bone plus marrow.
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Baseline and month 12 of the treatment
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Bone Histomorphometry - Trabecular Thickness (TbTh)
기간: Baseline and month 12 of the treatment
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Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy.
The ends of certain bones, known as cancellous bones, are actually not solid but are full of holes that are connected to each other by thin rods and plates of bone tissue known as trabeculae.
Trabeculae of bone provide structural support to the spongy bone found at the ends of long bones.
Trabeculae Trabecular Thickness (TbTh), a structural parameter, is the distance across individual trabecula.
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Baseline and month 12 of the treatment
|
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Bone Histomorphometry - Percent Mineralized Bone Volume (MdV/BV)
기간: Baseline and month 12 of the treatment
|
Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy.
Percent Mineralized Bone Volume is the percentage of Bone Volume consisting of mineralized bone.
Percent Mineralized Bone Volume is calculated as Mineralized Bone Volume (MdV) divided by Bone Volume (BV).
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Baseline and month 12 of the treatment
|
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Bone Histomorphometry - Mineralized Bone Volume (MdV)
기간: Baseline and month 12 of the treatment
|
Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy.
Bone mineralization is the process of laying down minerals on the matrix of the bone, with calcium and phosphorus as the most abundant minerals.
Mineralized Bone Volume (MdV) is the percentage of mineralized bone tissue.
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Baseline and month 12 of the treatment
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Bone Histomorphometry - Percent Osteoid Volume Relative to Bone Volume(OV/BV)
기간: Baseline and month 12 of the treatment
|
Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy.
Osteoid is the unmineralized, organic portion of the bone matrix that forms prior to the maturation of bone tissue.
The reported values indicates the percent of a given volume of bone that consists of unmineralized bone.
It is equal to Osteoid Volume (OV) divided by Bone Volume (BV).
|
Baseline and month 12 of the treatment
|
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Bone Histomorphometry - Percent Osteoid Volume Relative to Tissue Volume (OV/TV)
기간: Baseline and month 12 of the treatment
|
Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy.
Osteoid is the unmineralized, organic portion of the bone matrix that forms prior to the maturation of bone tissue.
The reported values indicates the percent of a given volume of tissue (bone + marrow) that consists of unmineralized bone.
It is equal to Osteoid Volume (OV) divided by Tissue Volume (TV).
|
Baseline and month 12 of the treatment
|
|
Bone Histomorphometry - Percent Osteoid Surface Relative to Bone Surface (OS/BS)
기간: Baseline and month 12 of the treatment
|
Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy.
Osteoid is the unmineralized, organic portion of the bone matrix that forms prior to the maturation of bone tissue.
The reported values indicates the percent of bone surface that consists of unmineralized bone.
It is equal to Osteoid Surface (OS) divided by Bone Surface (BS).
|
Baseline and month 12 of the treatment
|
|
Bone Histomorphometry - Percent Osteoblasts Relative to Bone Surface (OB/BS)
기간: Baseline and month 12 of the treatment
|
Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy.
Osteoblasts (OB) are cells that make bones by producing a matrix that becomes mineralized.
Bone mass is a balance between the osteoblasts (OB) that form the bone and cells called osteoclasts (OC) that break down the bone.
The reported values indicate the percent of bone surface (BS) that is made up of osteoblasts (OB).
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Baseline and month 12 of the treatment
|
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Bone Histomorphometry - Percent Osteoclasts Relative to Bone Surface (OC/BS)
기간: Baseline and month 12 of the treatment
|
Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy.
Osteoclasts (OC) are cells responsible for bone resorption, which is the breaking down of bones.
Osteoclasts make and secrete digestive enzymes that break up or dissolve the bone tissue.
Bone mass is a balance between the osteoblasts (OB) cells that form the bone and the osteoclasts (OC) cells that break down the bone.
The reported values indicate the percent of bone surface (BS) that consists of osteoclasts (OC).
|
Baseline and month 12 of the treatment
|
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Bone Histomorphometry - Percent Eroded Surface Relative to Bone Surface (ES/BS)
기간: Baseline and month 12 of the treatment
|
Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy.
Osteoclasts (OC) are cells responsible for bone resorption, which is the breaking down of bones.
Osteoclasts make and secret digestive enzymes tha break up or dissolve the bone tissue.
An eroded surface (ES) is the surface of the lacuna ( a cavity or depression in the bone) generated by an active OC.
The reported values indicate the percent of eroded surface relative to bone surface (BS).
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Baseline and month 12 of the treatment
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Bone Histomorphometry - Bone Formation Rate
기간: Baseline and month 12 of the treatment
|
Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy.
Osteoblasts (OB) are cells that make bones by producing a matrix that becomes mineralized.
Bone formation rate (BFR) indicates how much of the bone is actively mineralizing; it is determined by the number of active OB and the average work of each OB.
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Baseline and month 12 of the treatment
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Bone Histomorphometry - Osteoid Volume (OV)
기간: Baseline and month 12 of the treatment
|
Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy.
Osteoid is the unmineralized, organic portion of the bone matrix that forms prior to the maturation of bone tissue.
The reported values indicates the Osteoid Volume (OV), the volume of bone that consists of unmineralized bone.
|
Baseline and month 12 of the treatment
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Maria Coco, MD, MS, Montefiore Medical Center
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 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
2002년 10월 1일
기본 완료 (실제)
2008년 7월 1일
연구 완료 (실제)
2008년 7월 1일
연구 등록 날짜
최초 제출
2005년 12월 15일
QC 기준을 충족하는 최초 제출
2005년 12월 15일
처음 게시됨 (추정)
2005년 12월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 3월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 2월 5일
마지막으로 확인됨
2019년 2월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 02-08-224
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예
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Baylor College of MedicinePatient-Centered Outcomes Research Institute; M.D. Anderson Cancer Center; The University... 그리고 다른 협력자들완전한말기 심부전 | BTT(Bridge-to-Transplant LVAD 배치) | 목적지 치료 LVAD 배치(DT) | LVAD 배치 거부(거절자) | LVAD 간병인미국
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