NCT00887965已完成2 期
A Transiliac Crest Bone Histology and Histomorphometry Study in Postmenopausal Women With Low Bone Mass or Osteoporosis Previously Treated With Denosumab
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 15
- 主要终点
- Number of Participants With Normal/Abnormal Bone Histology
研究概览
简要总结
To characterize the effects of discontinuation of denosumab therapy on variables of bone histology in postmenopausal women with low bone mass or osteoporosis. Patients who have received denosumab and completed study 20050179 (NCT00293813), completed study 20050141 (NCT00330460), completed study 20060237 (NCT00515463), completed study 20030216 (NCT00089791) but did not enroll in study 20060289 (NCT00523341) will be included in this study. Patients who will participate in the off-treatment imaging study for 20080747 (NCT00890981) are also eligible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ambulatory postmenopausal women
- •Received denosumab and completed study 20050179 (NCT00293813), completed study 20050141 (NCT00330460), completed study 20060237 (NCT00515463), completed study 20030216 (NCT00089791) but did not enroll in study 20060289 (NCT00523341). Patients who will participate in the off-treatment imaging study for 20080747 (NCT00890981) also are eligible.
- •Completed participation in eligible studies ≥ 12 and ≤ 36 months prior to screening
- •Provide signed informed consent
排除标准
- •Did not receive denosumab in studies 20050141, 20060237, 20030216, or
- •Discontinued investigational product before end of study visit for studies 20050141, 20060237, 20030216, or
- •Received > 1 month osteoporosis treatment since having completed studies 20050141, 20060237, 20030216, or
- •Received zoledronic acid at any time after ending study participation in parent studies 20050141, 20050179, 20030216, or
- •Newly diagnosed with any of the following conditions during the intervening period since completing studies 20050141, 20060237, 20030216, or 20050179:
- •Hyperthyroidism (stable on anti-thyroid therapy or post-ablation is allowed, if the Thyroid Stimulating Hormone is within the normal range)
- •Hypothyroidism (stable on thyroid replacement therapy is allowed, if the Thyroid Stimulating Hormone is within the normal range)
- •Hyper- or hypoparathyroidism
- •Osteomalacia
- •Paget's disease of bone
- •Other bone diseases which affect bone metabolism (eg, osteopetrosis, osteogenesis imperfecta)
- •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.
- •Permanently non-ambulatory subjects (use of assistive device eg cane, walker is permitted).
- •Has known or suspected sensitivity or contraindication to tetracycline derivatives.
- •Received any investigational product other than denosumab.
- •Current use of the following osteoporosis agents: bisphosphonates, calcitonin, fluoride, parathyroid hormone analogue, selective estrogen receptor modulators, systemic oral or transdermal estrogen (except vaginal preparations and estrogen creams which are acceptable), strontium or tibolone.
- •Has undergone bilateral transiliac crest bone biopsy in the past.
- •Current use of medications that, in the opinion of the investigator, cannot be discontinued and may compromise the safety of the subject when undergoing the bone biopsy procedure (eg, aspirin, warfarin, high-dose heparin).
- •Current use of systemic glucocorticoid therapy (topical or nasal steroids are permitted).
- •Evidence of coagulopathy that in the opinion of the investigator, may compromise patient safety when subjected to the bone biopsy procedure.
- •Any disorder that, in the opinion of the investigator, may compromise the ability of the participant to give written informed consent and/or comply with study procedures.
研究组 & 干预措施
Previous denosumab
Other
Participants who had previously received denosumab received a transiliac crest bone biopsy performed following standard labeling procedures with tetracycline or tetracycline derivative.
干预措施: Previous denosumab (Drug)
结局指标
主要结局
Number of Participants With Normal/Abnormal Bone Histology
时间窗: 25-34 days post-Day 1
The number of participants with normal/abnormal bone histology as assessed by bone biopsy samples at the central histomorphometric facility. Normal bone histology is characterized by: - normal lamellar bone, - normal mineralization or - osteoid (the organic matrix of bone; young bone that has not undergone calcification). Biopsies with abnormal bone histology are characterized by: - osteomalacia, - marrow fibrosis, - clinically significant marrow abnormality or - woven bone.
次要结局
- Bone Histomorphometry: Surface Density(25-34 days post-Day 1)
- Bone Histomorphometry: Osteoblast - Osteoid Interface(25-34 days post-Day 1)
- Bone Histomorphometry: Osteoid Surface(25-34 days post-Day 1)
- Bone Histomorphometry: Trabecular Separation(25-34 days post-Day 1)
- Bone Histomorphometry: Cortical Width(25-34 days post-Day 1)
- Bone Histomorphometry: Osteoclast Number - Surface Based(25-34 days post-Day 1)
- Bone Histomorphometry: Double-label Surface(25-34 days post-Day 1)
- Bone Histomorphometry: Cancellous Bone Volume(25-34 days post-Day 1)
- Bone Histomorphometry: Osteoid Volume(25-34 days post-Day 1)
- Bone Histomorphometry: Mineralization Lag Time(25-34 days post-Day 1)
- Bone Histomorphometry: Trabecular Number(25-34 days post-Day 1)
- Bone Histomorphometry: Trabecular Thickness(25-34 days post-Day 1)
- Bone Histomorphometry: Osteoclast Number - Length Based(25-34 days post-Day 1)
- Bone Histomorphometry: Osteoid Width(25-34 days post-Day 1)
- Bone Histomorphometry: Wall Thickness(25-34 days post-Day 1)
- Bone Histomorphometry: Eroded Surface/Bone Surface(25-34 days post-Day 1)
- Bone Histomorphometry: Single-label Surface(25-34 days post-Day 1)
- Bone Histomorphometry: Total Mineralizing Surface(25-34 days post-Day 1)
- Bone Histomorphometry: Mineral Apposition Rate(25-34 days post-Day 1)
- Bone Histomorphometry: Adjusted Mineral Apposition Rate(25-34 days post-Day 1)
- Bone Histomorphometry: Bone Formation Rate - Surface Based(25-34 days post-Day 1)
- Bone Histomorphometry: Bone Formation Rate - Volume Based(25-34 days post-Day 1)
- Bone Histomorphometry: Formation Period(25-34 days post-Day 1)
- Bone Histomorphometry: Activation Frequency(25-34 days post-Day 1)
- C-Telopeptide (CTX-1)(Day 3 or Day 20)
- Procollagen Type 1 N-terminal Peptide (P1NP)(Day 3 or Day 20)
研究者
相似试验
招募中
不适用
Effects of denosumab for bone resorption in the femur after total hip arthroplastypatients treated with primary total hip arthroplastyJPRN-UMIN000028169Yokohama City University80
进行中（未招募）
4 期
Denosumab (DMAB) Discontinuation and Switching in Glucocorticoid-Induced Osteoporosis (GIOP): a Pilot StudyOsteoporosisNCT04177940University of Alabama at Birmingham45
已完成
2 期
Denosumab and Osteoporotic Vertebral Compression FractureOsteoporotic Vertebral Compression FractureNCT05058443Shenzhen People's Hospital90
Unknown
不适用
Clinical Results of Bisphosphonate and Denosumab Therapy Following Teriparatide Therapy for JapaneseOsteoporosisNCT02166437Tomidahama Hospital500
Unknown
不适用
Effects of Denosumab Therapy for JapaneseOsteoporosisNCT02491515Tomidahama Hospital500