VERtebral Fracture Treatment Comparisons in Osteoporotic Women (VERO)
2019年9月9日 更新者：Eli Lilly and Company
Teriparatide and Risedronate in the Treatment of Patients With Severe Postmenopausal Osteoporosis: Comparative Effects on Vertebral Fractures
The primary purpose of participation in this study is to answer whether teriparatide is superior to risedronate in reducing the occurrence of new vertebral fractures during 24 months of therapy.
研究概览
研究类型
介入性
注册 (实际的)
1366
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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British Columbia
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Kelowna、British Columbia、加拿大、V1Y3G5
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Vancouver、British Columbia、加拿大、V5Z 4E1
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Nova Scotia
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Halifax、Nova Scotia、加拿大、B3H 1V7
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Ontario
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Hamilton、Ontario、加拿大、L8N 1Y2
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Toronto、Ontario、加拿大、M5G 2C4
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Quebec
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Montreal、Quebec、加拿大、H3T 1E2
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Sainte-Foy、Quebec、加拿大、G1V 3M7
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Trois-Rivieres、Quebec、加拿大、G8Z 1Y2
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Saskatchewan
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Saskatoon、Saskatchewan、加拿大、S7K 0H6
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Budapest、匈牙利、1094
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Debrecen、匈牙利、4043
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Eger、匈牙利、3300
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Kaposvar、匈牙利、7400
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Szeged、匈牙利、6720
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Graz、奥地利、8036
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Hohenems、奥地利、6845
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Linz、奥地利、4020
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Vienna、奥地利、A-1060
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Brasilia、巴西、71625-009
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Rio De Janeiro、巴西、22271-100
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São Paulo、巴西、05437-010
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Athens、希腊、10676
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Kifissia、希腊、14561
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Patras、希腊、26500
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Thessaloniki、希腊、54642
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Dresden、德国、01067
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Frankfurt、德国、60528
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Hamburg、德国、22415
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Leipzig、德国、04103
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Magdeburg、德国、39110
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Marburg、德国、35043
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Firenze、意大利、50134
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Genova-Nervi、意大利、16167
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Orbassano、意大利、10043
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Padova、意大利、35128
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Rome、意大利、00161
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Torino、意大利、10126
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Valeggio Sul Mincio、意大利、37067
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Ceske Budejovice、捷克语、37005
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Klatovy、捷克语、33938
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Prague、捷克语、128 08
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Uherske Hradiste、捷克语、686 01
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Brussels、比利时、1070
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Genk、比利时、3600
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Gent、比利时、9000
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Gilly、比利时、6060
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Laken、比利时、1020
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Leuven、比利时、3000
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Liège、比利时、4020
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Merksem、比利时、2170
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Mons、比利时、7000
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Caen、法国、14033
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La Crau、法国、83260
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Lyon、法国、69003
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Orleans、法国、45032
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Saint-Etienne、法国、42055
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Toulouse、法国、31059
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Bialystok、波兰、15-351
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Elblag、波兰、82-300
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Lublin、波兰、20-582
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Poznan、波兰、60-218
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Swidnik、波兰、21-040
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Warsaw、波兰、02-118
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San Juan、波多黎各、00918
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Alabama
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Birmingham、Alabama、美国、35294
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California
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Concord、California、美国、94520
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Fresno、California、美国、93720
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Laguna Hills、California、美国、92653
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Lancaster、California、美国、93534
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Tustin、California、美国、92780
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Colorado
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Lakewood、Colorado、美国、80227
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Connecticut
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Danbury、Connecticut、美国、06810
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Florida
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Orlando、Florida、美国、32804
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Georgia
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Gainesville、Georgia、美国、30501
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Indiana
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Evansville、Indiana、美国、47714
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Indianapolis、Indiana、美国、46202
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Kansas
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Topeka、Kansas、美国、66606
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Maryland
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Bethesda、Maryland、美国、20817
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Michigan
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Detroit、Michigan、美国、48202
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Nebraska
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Omaha、Nebraska、美国、68131
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New Jersey
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Clifton、New Jersey、美国、07012
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Freehold、New Jersey、美国、07728
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New Mexico
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Albuquerque、New Mexico、美国、87106
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North Carolina
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Asheville、North Carolina、美国、28803
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Greensboro、North Carolina、美国、27408
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North Dakota
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Fargo、North Dakota、美国、58103
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Oregon
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Bend、Oregon、美国、97701
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Pennsylvania
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Duncansville、Pennsylvania、美国、16635
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pittsburgh、Pennsylvania、美国、15213
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Wyomissing、Pennsylvania、美国、19610
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Texas
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Dallas、Texas、美国、75231
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Washington
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Seattle、Washington、美国、98122
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Spokane、Washington、美国、99204
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Wisconsin
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Madison、Wisconsin、美国、53705
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Alcira、西班牙、46600
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Barcelona、西班牙、08025
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Cadiz、西班牙、11009
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Madrid、西班牙、28046
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Sabadell、西班牙、08208
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Valencia、西班牙、46026
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Buenos Aires、阿根廷、C1128AAF
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Caba、阿根廷、C1425AGC
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Mar Del Plata、阿根廷、B7600DHK
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
45年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Postmenopausal women with osteoporosis, as defined by low bone mineral density (BMD), i.e. anterior-posterior lumbar spine, total hip or femoral neck BMD ≥1.5 standard deviations below the average BMD for young, healthy, non-Hispanic, Caucasian women
- A minimum of 2 moderate or 1 severe vertebral fragility fractures (confirmed by central reader) were required
Exclusion Criteria:
- Increased risk of osteosarcoma
- History of unresolved skeletal diseases that affect bone metabolism
- History of atypical subtrochanteric or diaphyseal femoral fractures
- Abnormally high or low calcium levels
- Abnormally high parathyroid hormone (PTH) levels
- Severe vitamin D deficiency
- Abnormal thyroid function not corrected by therapy
- History of malignant neoplasms in the last 5 years
- Active liver disease, clinical jaundice
- Significant impairment of hepatic or renal function
- History of nephro- or urolithiasis
- Previous or planned kypho- or vertebroplasty
- Active or risk for osteonecrosis of the jaw
- Active or recent history of upper gastrointestinal disorders
- Unable to stand or sit in the upright position for at least 30 minutes
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Teriparatide
Teriparatide 20 microgram (µg) administered by subcutaneous (SC) injection once daily for 24 months. Placebo given orally once weekly for 24 months. Elemental Calcium 500 to 1000 milligram per day and Vitamin D 400 to 800 International Units per day, both administered orally once daily while receiving treatment. |
施行SC
其他名称：
口服给药
Teriparatide arm placebo administered orally. Risedronate arm placebo administered SC.
Administered orally
|
|
有源比较器：Risedronate
Risedronate 35 milligram (mg) administered orally once weekly for 24 months. Placebo given by SC injection once daily for 24 months. Elemental Calcium 500 to 1000 milligram per day and Vitamin D 400 to 800 International Units per day, both administered orally once daily while receiving treatment. |
口服给药
口服给药
Teriparatide arm placebo administered orally. Risedronate arm placebo administered SC.
Administered orally
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of Participants With New Vertebral Fractures
大体时间：Baseline through 24 Months
|
The incidence of new vertebral fractures was assessed by quantitative vertebral morphometry measurements (QM) with qualitative visual semiquantitative grading (SQ) confirmation. A new vertebral fracture was diagnosed in a vertebra that was non-fractured at the baseline radiological examination. It was defined as a loss of vertebral body height of at least 20% and 4 mm from the baseline radiograph by vertebral QM, based upon placement of six points by a trained, central reader. Any fractures identified by QM were confirmed using SQ: if the vertebral body also had an increase of one or more severity grade, it was considered an incident vertebral fracture. |
Baseline through 24 Months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of Participants With Pooled New and Worsening Vertebral Fractures
大体时间：Baseline through 24 Months
|
Worsening of a pre-existing fracture was considered if the decrease in vertebral height was at least one severity grade in the semi-quantitative assessment, confirmed by a trained central reader, where vertebrae were graded as normal (SQ0) or as with mild (SQ1), moderate (SQ2), or severe (SQ3) fractures, defined as ~20 to 25% (mild), ~25 to 40% (moderate) or ~40% or more (severe) decrease in anterior, central, or posterior vertebral height (T4 to L4).
|
Baseline through 24 Months
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Proportion of Participants With Pooled Clinical Vertebral and Non-Vertebral Fragility Fractures
大体时间：Baseline through 24 Months
|
A clinical vertebral fracture was defined as a new or worsening vertebral fracture, confirmed by radiography, that was associated with signs and symptoms highly suggestive of a vertebral fracture. All non-vertebral fractures that occurred and were diagnosed between visits required the confirmation by the site investigators after evaluating the original x-ray film(s), the radiology or surgical report. For clinical vertebral fractures, the final confirmation of the diagnosis required the centralized evaluation by a trained, independent reader. |
Baseline through 24 Months
|
|
Proportion of Participants With Non-Vertebral Fragility Fractures
大体时间：Baseline through 24 Months
|
A non-vertebral fracture is a fracture at any of the following non-vertebral sites: clavicle, scapula, ribs, sternum, sacrum, coccyx, humerus, radius, ulna, carpus, pelvis, hip, femur, patella, tibia, fibula, ankle, calcaneus, tarsus, and metatarsal.
Non-vertebral fractures were determined by direct questioning at each visit, and confirmed by the site investigators by x-ray, radiology or surgical report.
Fractures resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving object were not considered fragility fractures but traumatic fractures.
|
Baseline through 24 Months
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Proportion of Participants With Major Non-Vertebral Fragility Fractures
大体时间：Baseline through 24 Months
|
A major non-vertebral fracture is a fracture at any of the following non-vertebral sites hip, radius, humerus, ribs, pelvis, tibia and femur.
Non-vertebral fractures were determined by direct questioning at each visit, and confirmed by the site investigators by x-ray, radiology or surgical report.
Fractures resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving.
|
Baseline through 24 Months
|
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Proportion of Participants With New Moderate and/or Severe Vertebral Fractures
大体时间：Baseline through 24 Months
|
Vertebrae were graded as moderate (SQ2), or severe (SQ3) fractures, based on ~25 to 40% (moderate) or ~40% or more (severe) decrease in anterior, central, or posterior vertebral height (T4 through L4).
|
Baseline through 24 Months
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Proportion of Participants With New Multiple (2 or More) Vertebral Fractures
大体时间：Baseline through 24 Months
|
Baseline through 24 Months
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Proportion of Participants With Pooled Fragility and Traumatic Non-Vertebral Fractures
大体时间：Baseline through 24 Months
|
Traumatic fractures were considered if resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving object.
|
Baseline through 24 Months
|
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Change From Baseline to 24 Months Endpoint in Height
大体时间：Baseline, 24 Months
|
Baseline, 24 Months
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Change From Baseline to 24 Months Endpoint in Back Pain Using an 11-point Numerical Pain Rating Scale
大体时间：Baseline, 24 Months
|
Participants rated the worst back pain during the 24 hours preceding the visit at baseline and each post-baseline visit.
An 11-point numerical back pain rating scale (rated from 0 = no back pain to 10 = worst possible back pain) was used.
|
Baseline, 24 Months
|
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Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (UK)
大体时间：Baseline, 24 Months
|
The EQ-5D-5L is a generic, multidimensional, health-related, quality-of-life instrument completed on five dimensions to measure health-related quality of life.
The profile allowed participants to rate their health state in five health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a five level scale (no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems).
The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.59 to 1.0.
A higher score indicates better health state.
|
Baseline, 24 Months
|
|
Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (US)
大体时间：Baseline, 24 Months
|
The EQ-5D-5L is a generic, multidimensional, health-related, quality-of-life instrument completed on five dimensions to measure health-related quality of life.
The profile allowed participants to rate their health state in five health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a five level scale (no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems).
The responses are used to derive the health state index scores using the United States (US) cross walk algorithm, with scores ranging from -0.11 to 1.0.
A higher score indicates better health state.
|
Baseline, 24 Months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Body JJ, Marin F, Kendler DL, Zerbini CAF, Lopez-Romero P, Moricke R, Casado E, Fahrleitner-Pammer A, Stepan JJ, Lespessailles E, Minisola S, Geusens P. Efficacy of teriparatide compared with risedronate on FRAX(R)-defined major osteoporotic fractures: results of the VERO clinical trial. Osteoporos Int. 2020 Oct;31(10):1935-1942. doi: 10.1007/s00198-020-05463-4. Epub 2020 May 30.
- Geusens P, Kendler DL, Fahrleitner-Pammer A, Lopez-Romero P, Marin F. Distribution of Prevalent and Incident Vertebral Fractures and Their Association with Bone Mineral Density in Postmenopausal Women in the Teriparatide Versus Risedronate VERO Clinical Trial. Calcif Tissue Int. 2020 Jun;106(6):646-654. doi: 10.1007/s00223-020-00683-6. Epub 2020 Mar 10.
- Minisola S, Marin F, Kendler DL, Geusens P, Zerbini CAF, Russo LA, Casado E, Fahrleitner-Pammer A, Stepan JJ, Lespessailles E, Moericke R, Bagur A, Lakatos P, Lopez-Romero P, Body JJ. Serum 25-hydroxy-vitamin D and the risk of fractures in the teriparatide versus risedronate VERO clinical trial. Arch Osteoporos. 2019 Jan 18;14(1):10. doi: 10.1007/s11657-019-0561-x.
- Geusens P, Marin F, Kendler DL, Russo LA, Zerbini CA, Minisola S, Body JJ, Lespessailles E, Greenspan SL, Bagur A, Stepan JJ, Lakatos P, Casado E, Moericke R, Lopez-Romero P, Fahrleitner-Pammer A. Effects of Teriparatide Compared with Risedronate on the Risk of Fractures in Subgroups of Postmenopausal Women with Severe Osteoporosis: The VERO Trial. J Bone Miner Res. 2018 May;33(5):783-794. doi: 10.1002/jbmr.3384. Epub 2018 Feb 9.
- Kendler DL, Marin F, Zerbini CAF, Russo LA, Greenspan SL, Zikan V, Bagur A, Malouf-Sierra J, Lakatos P, Fahrleitner-Pammer A, Lespessailles E, Minisola S, Body JJ, Geusens P, Moricke R, Lopez-Romero P. Effects of teriparatide and risedronate on new fractures in post-menopausal women with severe osteoporosis (VERO): a multicentre, double-blind, double-dummy, randomised controlled trial. Lancet. 2018 Jan 20;391(10117):230-240. doi: 10.1016/S0140-6736(17)32137-2. Epub 2017 Nov 9. Erratum In: Lancet. 2017 Nov 30;: Lancet. 2018 Dec 1;392(10162):2352.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年10月1日
初级完成 (实际的)
2016年7月1日
研究完成 (实际的)
2016年7月1日
研究注册日期
首次提交
2012年10月16日
首先提交符合 QC 标准的
2012年10月16日
首次发布 (估计)
2012年10月17日
研究记录更新
最后更新发布 (实际的)
2019年9月23日
上次提交的符合 QC 标准的更新
2019年9月9日
最后验证
2019年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 14536
- B3D-EW-GHDW (其他标识符：Eli Lilly and Company)
- 2012-000123-41 (EudraCT编号)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD 共享时间框架
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later.
Data will be indefinitely available for requesting.
IPD 共享访问标准
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD 共享支持信息类型
- 研究方案
- 树液
- 企业社会责任
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.