The Effect of Osteoporotic Medications on Vertebral Bone Quality Score
The goal of this clinical trial is to determine the change in VBQ score, T score, TBS, and Hounsfield Units (HU) after 3-6 months of treatment with abaloparatide in osteoporotic patients who will undergo spinal fusion and decompression for lumbar degenerative disease. The main question[s] it aims to answer is:
Does abaloparatide improve bone density in these patients, as defined by VBQ score compared to traditional methods such as DEXA and Hounsfield Units Does abaloparatide reduce the incidence of postoperative mechanical complications, including adjacent segment disease, subsidence, and proximal junctional kyphosis (PKJ)?
Participants will undergo a presurgical assessments and trained in clinic on the subcutaneous application of abaloparatide. Prior to treatment, patients will have baseline assessments, including a lumbar MRI, DEXA scan, and lumbar CT. Post-surgically, participants will administer abaloparatide and return to clinic after 3-6 months for follow-up assessments including a new MRI, lumbar CT, and DEXA scan. Patients will be followed for up to 2 years postoperatively to identify complications such as adjacent segment disease, pseudarthrosis, failure of instrumentation, and PJK.
연구 개요
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 장소
-
-
New York
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Buffalo, New York, 미국, 14203
- University at Buffalo Neurosurgery
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-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
Diagnosis of Osteoporosis based on the following criteria:
- Fragility fracture (low trauma fracture similar to a fall from a standing position except for fracture to the skull, face, fingers, and toes)
- T score <-2.5
- T-score -1 to -2.5 with a high FRAX or high TBS adjusted FRAX (with a 10-year probability of major osteoporotic fracture ≥20% or a 10-year probability of hip fracture ≥3%)
- Fulfill criteria for treatment with anabolic therapy, as outlined in the American Association of Clinical Endocrinologist guidelines for the diagnosis and treatment of postmenopausal osteoporosis in women and Evidence-Based Guideline for the management of osteoporosis in men.
- Lumbar Degenerative Disease as evidenced by a diagnosis of spondylosis, spondylolisthesis, degenerative disc disease with spinal stenosis, and degenerative scoliosis
- Have or be willing to have a DEXA scan, lumbar MRI, and lumbar CT within 3 months of the start of Abaloparatide
- If on thyroid hormone replacement, having been on it for at least 6 months
Exclusion Criteria:
- Previous lumbar surgery
- Past medical history of: sarcoma, including osteosarcoma, paget disease or other skeletal malignancies, unexplained elevations of alkaline phosphatase, prior external beam radiation, and pre-existing hypercalcemia
- Diagnosis of secondary osteoporosis
- Vitamin D deficit
- History of prior treatment with TPTD and ABL
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Abaloparatide
3-6 months of self-administered abaloparatide in osteoporotic patients will undergo spinal fusion and decompression for lumbar degenerative disease
|
3-6 months of treatment with abaloparatide in osteoporotic patients who will undergo spinal fusion and decompression for lumbar degenerative disease
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Improvement in Bone Quality
기간: 6 weeks post-op
|
Improvement in bone quality, using Vertebral Bone Quality
|
6 weeks post-op
|
|
Improvement in Bone Quality
기간: 6 weeks post-op
|
Improvement in bone quality, using Hounsfield Units
|
6 weeks post-op
|
|
Improvement in Bone Quality
기간: 6 weeks post-op
|
Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)
|
6 weeks post-op
|
|
Improvement in Bone Quality
기간: 6 months post-op
|
Improvement in bone quality, using Vertebral Bone Quality
|
6 months post-op
|
|
Improvement in Bone Quality
기간: 6 months post-op
|
Improvement in bone quality, using Hounsfield Units
|
6 months post-op
|
|
Improvement in Bone Quality
기간: 6 months post-op
|
Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)
|
6 months post-op
|
|
Improvement in Bone Quality
기간: 12 months post-op
|
Improvement in bone quality, using Vertebral Bone Quality
|
12 months post-op
|
|
Improvement in Bone Quality
기간: 12 months post-op
|
Improvement in bone quality, using Hounsfield Units
|
12 months post-op
|
|
Improvement in Bone Quality
기간: 12 months post-op
|
Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)
|
12 months post-op
|
|
Improvement in Bone Quality
기간: 24 months post-op
|
Improvement in bone quality, using Vertebral Bone Quality
|
24 months post-op
|
|
Improvement in Bone Quality
기간: 24 months post-op
|
Improvement in bone quality, using Hounsfield Units
|
24 months post-op
|
|
Improvement in Bone Quality
기간: 24 months post-op
|
Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)
|
24 months post-op
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Surgical Complications
기간: 6 weeks post-operatively
|
Presence of complications associated with fusion, such as Proximal Junctional Kyphosis (PJK), proximal junctional failure (PJF), pseudoarthrosis, subsidence, adjacent segment disease, mechanical failure, reoperation, and patient-reported outcomes.
|
6 weeks post-operatively
|
|
Surgical Complications
기간: 6 months post-operatively
|
Presence of complications associated with fusion, such as PJK, PJF, pseudoarthrosis, subsidence, adjacent segment disease, mechanical failure, reoperation, and patient-reported outcomes.
|
6 months post-operatively
|
|
Surgical Complications
기간: 12 months post-operatively
|
Presence of complications associated with fusion, such as PJK, PJF, pseudoarthrosis, subsidence, adjacent segment disease, mechanical failure, reoperation, and patient-reported outcomes.
|
12 months post-operatively
|
|
Surgical Complications
기간: 24 months post-operatively
|
Presence of complications associated with fusion, such as PJK, PJF, pseudoarthrosis, subsidence, adjacent segment disease, mechanical failure, reoperation, and patient-reported outcomes.
|
24 months post-operatively
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 20254288
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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