Bone Histomorphometry of the Proximal Femur in Denosumab-treated Subjects Undergoing Total Hip Replacement
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 6
- 试验地点
- 4
- 主要终点
- Percentage of Participants With Modeling Based Bone Formation in the Femoral Neck
研究概览
简要总结
The primary objective of this study is to determine the incidence of modeling-based bone formation in the femoral neck in participants who have received denosumab and are undergoing total hip replacement (THR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has provided informed consent/assent prior to initiation of any study-specific activities/procedures
- •Ambulatory postmenopausal women and men with osteoporosis
- •Scheduled to undergo elective THR due to osteoarthritis of the hip
- •Received at least 2 doses of denosumab 60 mg subcutaneously over 18 months
- •Last dose of denosumab within 6 months of scheduled THR
排除标准
- •Received treatment for osteoporosis other than denosumab in one year prior to THR
- •Subjects with current diagnosis of any of the following conditions are excluded
- •Current, uncontrolled hypo- or hyperthyroidism (subjects who have controlled hypo- or hyperthyroidism may be eligible, provided that they have been on a stable therapy for at least 3 months [per subject report])
- •Current, hypo- or hyperparathyroidism
- •Osteomalacia
- •Paget's disease of bone
- •Other bone diseases which affect bone metabolism (eg, osteopetrosis, osteogenesis imperfecta)
- •Severe chronic kidney disease (CKD), defined as CKD stage 4 or greater
- •Malignancy within the last 5 years (except cervical carcinoma in situ or basal cell carcinoma)
- •Self-reported alcohol or drug abuse within the previous 12 months
- •Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s)
- •Other investigational procedures while participating in this study are excluded
- •Subject has known sensitivity to any of the products to be administered (eg, tetracycline, demeclocycline) during study
- •Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge
- •History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
研究组 & 干预措施
Osteoarthritis Participants
Participants previously treated with denosumab and planning to undergo total hip replacement (THR) received one cycle of tetracycline administered at either 250 mg four times a day or 500 mg twice a day for 3 days and one cycle of demeclocycline administered at either 150 mg four times a day or 300 mg twice a day for 3 days, ten days after last dose of tetracycline in cycle 1. THR surgery was performed 5 to 42 days after the last dose of demeclocycline.
干预措施: Tetracycline (Other)
Osteoarthritis Participants
Participants previously treated with denosumab and planning to undergo total hip replacement (THR) received one cycle of tetracycline administered at either 250 mg four times a day or 500 mg twice a day for 3 days and one cycle of demeclocycline administered at either 150 mg four times a day or 300 mg twice a day for 3 days, ten days after last dose of tetracycline in cycle 1. THR surgery was performed 5 to 42 days after the last dose of demeclocycline.
干预措施: Total Hip Replacement (Procedure)
Osteoarthritis Participants
Participants previously treated with denosumab and planning to undergo total hip replacement (THR) received one cycle of tetracycline administered at either 250 mg four times a day or 500 mg twice a day for 3 days and one cycle of demeclocycline administered at either 150 mg four times a day or 300 mg twice a day for 3 days, ten days after last dose of tetracycline in cycle 1. THR surgery was performed 5 to 42 days after the last dose of demeclocycline.
干预措施: Demeclocycline (Other)
结局指标
主要结局
Percentage of Participants With Modeling Based Bone Formation in the Femoral Neck
时间窗: Days 22-58 (at the time of hip replacement surgery)
Femoral neck bone samples were prepared according to standard procedures for bone histology and bone histomorphometry at a central bone histomorphometry facility. Modeling based formation units in active bone-forming, tetracycline-labeled surfaces were identified by a smooth cement line. The percentage of participants with fluorochrome labeling present in the cancellous or periosteal, or endocortical surfaces of the femoral neck indicative of modeling-based bone formation is reported.
次要结局
- Modeling Based Formation Units in the Femoral Neck(Days 22-58 (at the time of hip replacement surgery))
- Overfilled Remodeling-based Formation Units in the Femoral Neck(Days 22-58 (at the time of hip replacement surgery))
- Remodeling-based Formation Units Including Overfilled Units in the Femoral Neck(Days 22-58 (at the time of hip replacement surgery))