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Effect of Anabolic and Antiresorptive Therapy on Bone Quality in Osteoporosis

合成代谢和抗吸收治疗对骨质疏松症骨质量的影响

基本信息

批准号：
9763446
负责人：
Joy Tsai
金额：
$ 17.01万
依托单位：
MASSACHUSETTS GENERAL HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-09-01 至 2020-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9763446
关键词：
Acute Advisory Committees Affect Age Anabolic Agents Biomechanics Biometry Bone Density Bone Resorption Bone Tissue Clinical Investigator Clinical Research Clinical Trials Combined Modality Therapy Committee Members Complement Computer software Country Development Plans Distal Dose Educational workshop Endocrine Exposure to Finite Element Analysis Forteo Fracture Functional disorder Funding General Hospitals Generations Goals Grant Health Healthcare Systems Hip region structure Human Research Ethics Image Imaging Techniques Incidence Individual Institution Investigation Ligands Massachusetts Measures Medicine Mentored Patient-Oriented Research Career Development Award Mentors Mentorship Metabolic Bone Diseases Metabolism Methods Minerals Monoclonal Antibodies Nuclear Osteoblasts Osteoclasts Osteogenesis Osteoporosis Osteoporotic Patients Peripheral Physicians Physiological Physiology Population Porosity Postmenopause Procedures Property Public Health Radial Research Research Activity Research Personnel Resolution Resources Scientist Site Structure Techniques Technology Time Training United States Vertebral column Vocational Guidance Woman advanced disease aging population base bisphosphonate bone bone imaging bone quality bone strength bone turnover career development catalyst clinical investigation comparative cortical bone cost design effective therapy evidence base experience fracture risk improved in vivo inhibiting antibody innovation instructor medical schools minimally invasive musculoskeletal imaging non-invasive imaging novel novel strategies public health relevance receptor receptor binding skeletal standard of care symposium tibia treatment strategy

项目摘要

DESCRIPTION (provided by applicant): This proposal details a comprehensive five-year mentored career development plan for the candidate, Dr. Joy Tsai, to transition to an independently-funded investigator in patient-based research with a focus on metabolic bone disease. Dr. Joy Tsai is an Instructor in Medicine at Harvard Medical School and Assistant in Medicine at Massachusetts General Hospital. She is well supported by the institution and will devote the majority of her time to clinical investigation. She will have full access to the rich resources of the Endocrine Unit, the Bone Density Center, Clinical Research Center, and Harvard Catalyst CTSC. She has chosen mentors with complementary expertise: Dr. Benjamin Leder is a leading clinical investigator in the field of bone and mineral metabolism. Dr. Mary Bouxsein is a leader in the field of biomechanics and cutting-edge imaging techniques. Both investigators have a strong record of mentorship with trainees progressing to academic independence. Both mentors are well-funded and are invested in this candidate's career development. The Scientific Advisory committee members (Dr. Henry Kronenberg, Dr. Joel Finkelstein, and Dr. Miriam Bredella) have expertise in skeletal physiology, clinical trials, and advanced musculoskeletal imaging and will provide scientific advice and career guidance during the transition to independent investigation. The research proposed in this grant aims to mechanistically define the effects of anabolic and antiresorptive therapy on bone quality. Current agents are unable to completely restore skeletal integrity in most patients with severe osteoporosis and are inadequate to match the anticipated rise in fracture incidence in our country's aging population. Thus, continued efforts to develop innovative evidence-based osteoporosis treatment strategies are crucial. This research plan proposes to utilize advanced high-resolution non-invasive imaging of bone and direct in vivo assessments of bone strength to assess changes in skeletal integrity. These techniques will allow for 1) the characterization of the changes in microarchitecture and estimated strength in women assigned a novel combination treatment strategy; 2) the characterization of the changes in bone material properties in women receiving the above combination therapy; and 3) the direct comparison of microarchitecture and estimated bone strength in women who have been previously exposed to bisphosphonates as compared with bisphosphonate-naïve women. In so doing, this proposal will help define the effects of diverse therapies on bone quality, an understanding of which is crucial in the design of rational therapies for osteoporosis. The candidate's research activities will be complemented by structured career development activities. She will be trained in skeletal physiology concepts, principles of conduct of clinical research, biostatistics, and ethics of human research through formal coursework, national conferences, workshops, and daily interactions with her mentors and colleagues. In summary, this proposed K23 award will allow the candidate to gain the experience and training necessary to achieve her goal of becoming an independent clinical investigator.

描述（由申请人提供）：该提案详细说明了候选人Joy Tsai博士的全面五年职业发展计划，以过渡到以患者为基础的研究中的独立资助研究者，重点是代谢性骨病。蔡博士是哈佛医学院的医学讲师和马萨诸塞州总医院的医学助理。她得到了该机构的大力支持，并将把大部分时间用于临床研究。她将有充分的机会获得丰富的资源，内分泌单位，骨密度中心，临床研究中心，和哈佛催化剂CTSC。她选择了具有互补专业知识的导师：Benjamin Leder博士是骨和矿物质代谢领域的领先临床研究者。玛丽Bouxsein博士是生物力学和尖端成像技术领域的领导者。两位调查员都有很好的指导记录，学员逐渐走向学术独立。两位导师都有充足的资金，并投资于这位候选人的职业发展。科学顾问委员会成员（亨利·克罗嫩伯格博士、乔尔·芬克尔斯坦博士和米里亚姆·布雷德拉博士）在骨骼生理学、临床试验和先进的肌肉骨骼成像方面具有专业知识，并将在过渡到独立调查期间提供科学建议和职业指导。这项研究的目的是从机制上确定合成代谢和抗骨吸收治疗对骨质的影响。目前的药物不能完全恢复大多数严重骨质疏松症患者的骨骼完整性，也不足以满足我国老龄人口骨折发病率的预期上升。因此，继续努力开发创新的循证骨质疏松症治疗策略至关重要。该研究计划建议利用先进的高分辨率非侵入性骨成像和直接体内骨强度评估来评估骨骼完整性的变化。这些技术将允许：1）表征分配了新的组合治疗策略的女性的微结构和估计强度的变化; 2）表征接受上述组合治疗的女性的骨材料性质的变化;和3）直接比较微结构和估计骨强度的妇女谁曾接触过双膦酸盐相比，双膦酸盐-天真的女人在这样做的过程中，这一建议将有助于确定不同的治疗方法对骨质量的影响，理解这一点对于设计合理的骨质疏松症治疗方法至关重要。候选人的研究活动将得到结构化职业发展活动的补充。她将接受骨骼生理学概念、临床研究行为原则、生物统计学和人类伦理学方面的培训。通过正式课程作业、全国会议、研讨会以及与导师和同事的日常互动进行研究。总而言之，这个拟议的K23奖项将使候选人获得必要的经验和培训，以实现她成为一名独立的临床研究者的目标。

项目成果

期刊论文数量（8）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Bone mineral density response with denosumab in combination with standard or high-dose teriparatide: the DATA-HD RCT.

DOI：
10.1210/clinem/dgz163
发表时间：
2020-03
期刊：
The Journal of clinical endocrinology and metabolism
影响因子：
0
作者：
S. Ramchand;Natalie L David;B. Leder;J. Tsai
通讯作者：
S. Ramchand;Natalie L David;B. Leder;J. Tsai

Effects of Teriparatide, Denosumab, or Both on Spine Trabecular Microarchitecture in DATA-Switch: a Randomized Controlled Trial.

DOI：
10.1016/j.jocd.2017.05.007
发表时间：
2017-10
期刊：
Journal of clinical densitometry : the official journal of the International Society for Clinical Densitometry
影响因子：
0
作者：
Tsai JN;Jiang LA;Lee H;Hans D;Leder BZ
通讯作者：
Leder BZ

The Effect of Zoledronic Acid on Bone Microarchitecture and Strength after Denosumab and Teriparatide Administration: DATA-HD Study Extension.

DOI：
10.1002/jbmr.4737
发表时间：
2023-01
期刊：
JOURNAL OF BONE AND MINERAL RESEARCH
影响因子：
6.2
作者：
Ramchand, Sabashini K.;David, Natalie L.;Lee, Hang;Bruce, Michael;Bouxsein, Mary L.;Tsai, Joy N.;Leder, Benjamin Z.
通讯作者：
Leder, Benjamin Z.

Relationship between bone turnover and density with teriparatide, denosumab or both in women in the DATA study.

数据研究中女性特立帕肽、狄诺塞麦或两者的骨转换和密度之间的关系。