NCT04167163已完成4 期
An Open-Label Phase 2 Study of Abaloparatide to Mitigate Distal Femoral Bone Loss Following Total Knee Arthroplasty
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Change in Distal femoral Bone mineral density (BMD) at the 25% regions of interest (ROIs)
研究概览
简要总结
The investigator hypothesizes that treating osteoporotic patients with abaloparatide prior to and after total knee arthroplasty will significantly reduce the amount of bone loss.
详细描述
In primary unilateral total knee arthroplasty patients, The investigator will examine the effect of daily abaloparatide therapy in clinical osteoporotic patients beginning 3 months pre-op and continued for a total of 15 months. This will be compared to osteopenic patients receiving no therapy as well as previously published values in untreated osteoporotic patients 12 months following Total Knee Arthroplasty (TKA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Post-menopausal women and men age ge ≥ 55 years and scheduled to undergo primary TKA at the University of Wisconsin Total Joint Program.
- •Osteoporosis, i.e., BMD T-score (using female reference data) ≤ -2.5 at the lumbar spine, femoral neck OR total hip or ≤ -1.1 with Vertebral Fracture Assessment confirmed vertebral fracture or history of low-trauma nonvertebral fracture in the past 5 years OR osteopenia, BMD T-score (using female reference data) -1.1 to -2.4 at the lumbar spine, femoral neck or total hip and no prior low-trauma fracture.
- •Serum calcium (albumin-corrected), serum creatinine and Parathyroid(PTH) values all within the normal range and 25(OH)D > 10 ng/mL.
- •Willing to supplement with daily calcium and/or vitamin D3 at protocol specified doses.
- •Able to provide written informed consent.
排除标准
- •Unevaluable distal femur BMD due to hardware or other artifacts.
- •History of bone disorders (e.g., Paget's disease) other than osteoporosis.
- •History of prior external beam or implant radiation therapy involving the skeleton other than radioiodine.
- •History of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic or metabolic diseases, or immunologic, emotional and/or psychiatric disturbances that, in opinion of the principal investigator, would compromise study data validity.
- •History of Cushing's disease, growth hormone deficiency or excess, hyperthyroidism, hypo- or hyperparathyroidism or malabsorptive syndromes within the past year.
- •History of significantly impaired renal function (serum creatinine >2.0 mg/dL. If the serum creatinine is > 1.5 and ≤ 2.0 mg/dL, the calculated creatinine clearance (Cockcroft-Gault) must be ≥ 37 mL/min.
- •History of nephrolithiasis or urolithiasis within the past five years.
- •History of cancer in prior 5 years (basal cell or squamous skin cancer is permissible).
- •History of osteosarcoma at any time.
- •Patients known to be positive for Hepatitis B, Hepatitis C, HIV-1 or HIV-
- •Known hypersensitivity to any of the test materials or related compounds.
- •Prior treatment with PTH- or PTHrP-derived drugs, (ABL, teriparatide or PTH (1-84)).
- •Prior treatment with intravenous bisphosphonates at any time or oral bisphosphonates within the past three years. Patients who had received a short course of oral bisphosphonate therapy (3 months or less) may be enrolled as long as the treatment occurred 6 or more months prior to enrollment.
- •Treatment with fluoride or strontium in the past five years or prior treatment with bone-acting investigational agents at any time.
- •Treatment with calcitonin the past 6 months or denosumab in the past 18 months.
- •Treatment with anticonvulsants affecting vitamin D metabolism (phenobarbital, phenytoin, carbamazepine or primidone) or chronic heparin within the prior 6 months.
- •Treatment with anabolic steroids or calcineurin inhibitors (cyclosporin, tacrolimus)
- •Daily treatment with oral, intranasal or inhaled glucocorticoids in the prior 12 months.
- •Exposure to any investigational drug within 12 months.
- •Consumption of > 2 alcoholic drinks per day or use of illegal drugs within 12 months of screening.
- •Not suitable for study participation due to other reasons at the investigators discretion.
研究组 & 干预措施
Treatment group
Active Comparator
Those with clinical osteoporosis who elect ABL treatment.
ABL therapy will begin 3 months pre-TKA and continue for a total of 18 months. ABL will be administered by injection pen with dose of 80 mcg SC qDay.
干预措施: Abaloparatide (Drug)
结局指标
主要结局
Change in Distal femoral Bone mineral density (BMD) at the 25% regions of interest (ROIs)
时间窗: Baseline and 18 months
Bone mineral density change at the 25% ROI of the surgical leg
次要结局
- Change in Veterans RAND 12 (VR-12) Question Health Survey score(Baseline and 18 months)
- Forgotten Joint Survey(FJS) score(18 months)
- Change in body composition using bioelectrical impedance analysis of lean mass(Baseline and 18 months)
- Change in Distal femoral BMD at the 15% and 60 %ROI(Baseline and 18 months)
- Change in Femur cortical thickness at the 15%, 25% and 60% femur ROIs(Baseline and 18 months)
- Knee injury & Osteoarthritis Outcome Score (KOOS) JR(18 months)
- TKA complications: Number of participants needed revision surgery(18 months)
- TBS assessment by TRIP at the 15%, 25% and 60% femur ROIs(18 months)
- Change in body composition using bioelectrical impedance analysis of fat mass.(Baseline and 18 months)
- Change in body composition using bioelectrical impedance analysis of skeletal mass.(Baseline and 18 months)
- TKA complications: Number of participants had fracture(18 months)
- Precision Error on Knee Bone Density Measurement(up to 15 months)
研究者
研究点 (2)
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