Bisphosphonate Therapy for HIV-Infected Adults With Decreased Bone Mineral Density
Bisphosphonate Therapy for HIV-Associated Osteopenia
Bisphosphonates are a type of drug used to prevent and treat bone loss. The purpose of this study is to determine if zoledronate, an investigational bisphosphonate, can improve bone mineral density (BMD) in HIV-infected adults.
Study hypothesis: Zoledronate will reduce bone resorption in HIV-infected persons with osteopenia.
연구 개요
상세 설명
Decreased BMD and bone loss is estimated to affect up to 67.5% of the HIV-infected population. HIV-associated bone loss may be a result of antiretroviral treatment (ART), but can also be caused by the infection itself. To date, treatment for this bone loss has not been established. Before prescribing drugs to treat bone loss, physicians must take into account patients' already demanding ART schedules and potential nonadherence. This study will evaluate the efficacy of a single IV dose of zoledronate, an investigational bisphosphonate, in treating HIV-associated bone loss.
This study will last 1 year. Participants will be randomly assigned to receive zoledronate or placebo at study entry; their assigned intervention will be given in a 20- to 30-minute infusion on an outpatient basis. There will be 7 study visits: at screening, study entry, Week 2, and Months 3, 6, 9, and 12. Blood collection will occur at all visits. Medical history, a physical exam, a dual-energy x-ray absorptiometry (DEXA) scan to measure bone density, and a nutrition evaluation will occur at selected visits.
연구 유형
등록 (예상)
단계
- 2 단계
연락처 및 위치
연구 장소
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California
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San Diego, California, 미국, 92103
- University of California, San Diego
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- HIV-infected
- On stable antiretroviral regimen for at least 3 months
- Able to walk
- Lumbar spine or total hip BMD T-score at least 1.5 SD and no more than 3.5 SD below the mean BMD
- No prevalent fractures at entry OR 1 prevalent vertebral fracture that has been asymptomatic during the last 2 years prior to study entry
- HIV viral load of less than 5000 copies/ml within the 2 months prior to study entry
- CD4 count of more than 100 cells/mm3 within the 2 months prior to study entry
- Willing to use acceptable forms of contraception during the study period and for 6 months after study completion. Participants who are female and postmenopausal will be required to take hormone replacement therapy during this study.
Exclusion Criteria:
- Prior treatment with bisphosphonates or fluoride
- Use of supraphysiologic systemic estrogen/androgen therapy or corticosteroid therapy within the 3 months prior to study entry. Participants who have taken hormone replacement therapy are not excluded.
- Significant liver or kidney disease
- Hemoglobin less than 8 g/dL
- Serum calcium less than 8 mg/dL
- Laboratory evidence of low levels of estrogens or androgens
- Laboratory evidence of overactive parathyroid glands
- History of thyroid, parathyroid, or other endocrinologic disorder known to affect bone
- Current use of any therapy known to affect bone
- Current or history of cancer or chemotherapy
- Current or history of radiotherapy to the jaw
- Current osteomyelitis of the jaw or ongoing dental infection
- Recent tooth extraction or major dental procedure within 3 weeks of study entry
- Pregnancy or breastfeeding
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 1
Participants will receive zoledronate at study entry; their assigned intervention will be given in a 20- to 30-minute infusion on an outpatient basis
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Zoledronate infusion
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위약 비교기: 2
Participants will receive zoledronate placebo at study entry; their assigned intervention will be given in a 20- to 30-minute infusion on an outpatient basis
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Zoledronate placebo infusion
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Bone metabolic markers
기간: Throughout study
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Throughout study
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2차 결과 측정
결과 측정 |
기간 |
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Safety outcomes
기간: Throughout study
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Throughout study
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jeannie S. Huang, MD, MPH, University of California, San Diego
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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. .
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