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.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
New York
-
Buffalo、New York、アメリカ、14203
- University at Buffalo Neurosurgery
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Improvement in Bone Quality
時間枠：6 weeks post-op
|
Improvement in bone quality, using Vertebral Bone Quality
|
6 weeks post-op
|
|
Improvement in Bone Quality
時間枠：6 weeks post-op
|
Improvement in bone quality, using Hounsfield Units
|
6 weeks post-op
|
|
Improvement in Bone Quality
時間枠：6 weeks post-op
|
Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)
|
6 weeks post-op
|
|
Improvement in Bone Quality
時間枠：6 months post-op
|
Improvement in bone quality, using Vertebral Bone Quality
|
6 months post-op
|
|
Improvement in Bone Quality
時間枠：6 months post-op
|
Improvement in bone quality, using Hounsfield Units
|
6 months post-op
|
|
Improvement in Bone Quality
時間枠：6 months post-op
|
Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)
|
6 months post-op
|
|
Improvement in Bone Quality
時間枠：12 months post-op
|
Improvement in bone quality, using Vertebral Bone Quality
|
12 months post-op
|
|
Improvement in Bone Quality
時間枠：12 months post-op
|
Improvement in bone quality, using Hounsfield Units
|
12 months post-op
|
|
Improvement in Bone Quality
時間枠：12 months post-op
|
Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)
|
12 months post-op
|
|
Improvement in Bone Quality
時間枠：24 months post-op
|
Improvement in bone quality, using Vertebral Bone Quality
|
24 months post-op
|
|
Improvement in Bone Quality
時間枠：24 months post-op
|
Improvement in bone quality, using Hounsfield Units
|
24 months post-op
|
|
Improvement in Bone Quality
時間枠：24 months post-op
|
Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)
|
24 months post-op
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Surgical Complications
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 20254288
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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