Mechanisms Underlying the Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Cancellous Bone Formation Rate at Month 3
研究概览
简要总结
The purpose of this study is to examine, via iliac crest bone biopsies, the mechanism of combined teriparatide and denosumab on the bone of postmenopausal osteoporotic women after 3 months of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women aged 45+
- •postmenopausal
- •osteoporotic with high risk of fracture
排除标准
- •significant previous use of bone health modifying treatments
- •known congenital or acquired bone disease other than osteoporosis
- •significant renal disease, liver disease, cardiopulmonary disease, or psychiatric disease
- •abnormal calcium or parathyroid hormone level
- •serum vitamin D <20 ng/mL or >60ng/mL
- •serum alkaline phosphatase above upper normal limit with no explanation
- •anemia (hematocrit <32%)
- •history of malignancy (except non-melanoma skin carcinoma), radiation therapy, or gouty arthritis
- •history of urolithiasis within the last one year
- •excessive alcohol use or substance abuse
- •use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months
- •extensive dental work involving extraction or dental implant within the past or upcoming 2 months
- •known sensitivity to mammalian cell-derived drug products
- •known contraindications to denosumab, teriparatide, or any of their excipients
- •known contraindications to tetracycline, demeclocycline, or other antibiotics in this drug class
- •continuous use of tetracycline for >1-month duration within the last 10 years
研究组 & 干预措施
Teriparatide only
daily subcutaneous injection teriparatide for 3 months
干预措施: Teriparatide (Drug)
Denosumab only
one dose of subcutaneous injection denosumab
干预措施: Denosumab (Drug)
Denosumab and teriparatide
daily subcutaneous injection teriparatide for 3 months plus one dose of subcutaneous injection denosumab
干预措施: Teriparatide (Drug)
Denosumab and teriparatide
daily subcutaneous injection teriparatide for 3 months plus one dose of subcutaneous injection denosumab
干预措施: Denosumab (Drug)
结局指标
主要结局
Cancellous Bone Formation Rate at Month 3
时间窗: 3 months after first dose of study drug
Cancellous bone formation rate at month 3 is calculated from the cancellous (trabecular) compartment of the iliac crest bone biopsy specimens. Bone formation rate (BFR/BS, mm3/mm2/day): amount of new bone formed in unit time per unit of bone surface. It is calculated by multiplying the mineralizing surface/bone surface (MS/BS) by the mineral apposition rate (MAR) - see below for how MS/BS and MAR are calculated. Mineralizing surface (MS/BS, %): is the percent of bone surface that displays a tetracycline label reflecting active mineralization. It is calculated as the double-labeled surface plus one half of the single-labeled surface and is expressed as a function of total bone surface. It is a measure of the proportion of bone surface upon which new mineralized bone was being deposited during the period of tetracycline labeling. Mineral apposition rate (MAR mm/day): is the mean distance between the double labels, divided by the time interval between them.
次要结局
未报告次要终点
研究者
Benjamin Leder, MD
Principal Investigator
Massachusetts General Hospital