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.
調査の概要
研究の種類
介入
入学 (実際)
1366
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35294
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California
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Concord、California、アメリカ、94520
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Fresno、California、アメリカ、93720
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Laguna Hills、California、アメリカ、92653
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Lancaster、California、アメリカ、93534
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Tustin、California、アメリカ、92780
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Colorado
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Lakewood、Colorado、アメリカ、80227
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Connecticut
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Danbury、Connecticut、アメリカ、06810
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Florida
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Orlando、Florida、アメリカ、32804
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Georgia
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Gainesville、Georgia、アメリカ、30501
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Indiana
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Evansville、Indiana、アメリカ、47714
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Indianapolis、Indiana、アメリカ、46202
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Kansas
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Topeka、Kansas、アメリカ、66606
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Maryland
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Bethesda、Maryland、アメリカ、20817
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Michigan
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Detroit、Michigan、アメリカ、48202
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Nebraska
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Omaha、Nebraska、アメリカ、68131
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New Jersey
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Clifton、New Jersey、アメリカ、07012
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Freehold、New Jersey、アメリカ、07728
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New Mexico
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Albuquerque、New Mexico、アメリカ、87106
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North Carolina
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Asheville、North Carolina、アメリカ、28803
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Greensboro、North Carolina、アメリカ、27408
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North Dakota
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Fargo、North Dakota、アメリカ、58103
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Oregon
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Bend、Oregon、アメリカ、97701
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Pennsylvania
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Duncansville、Pennsylvania、アメリカ、16635
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Pittsburgh、Pennsylvania、アメリカ、15213
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Wyomissing、Pennsylvania、アメリカ、19610
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Texas
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Dallas、Texas、アメリカ、75231
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Washington
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Seattle、Washington、アメリカ、98122
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Spokane、Washington、アメリカ、99204
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Wisconsin
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Madison、Wisconsin、アメリカ、53705
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Buenos Aires、アルゼンチン、C1128AAF
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Caba、アルゼンチン、C1425AGC
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Mar Del Plata、アルゼンチン、B7600DHK
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Firenze、イタリア、50134
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Genova-Nervi、イタリア、16167
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Orbassano、イタリア、10043
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Padova、イタリア、35128
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Rome、イタリア、00161
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Torino、イタリア、10126
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Valeggio Sul Mincio、イタリア、37067
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Graz、オーストリア、8036
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Hohenems、オーストリア、6845
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Linz、オーストリア、4020
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Vienna、オーストリア、A-1060
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British Columbia
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Kelowna、British Columbia、カナダ、V1Y3G5
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Vancouver、British Columbia、カナダ、V5Z 4E1
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Nova Scotia
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Halifax、Nova Scotia、カナダ、B3H 1V7
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Ontario
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Hamilton、Ontario、カナダ、L8N 1Y2
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Toronto、Ontario、カナダ、M5G 2C4
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Quebec
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Montreal、Quebec、カナダ、H3T 1E2
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Sainte-Foy、Quebec、カナダ、G1V 3M7
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Trois-Rivieres、Quebec、カナダ、G8Z 1Y2
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Saskatchewan
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Saskatoon、Saskatchewan、カナダ、S7K 0H6
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Athens、ギリシャ、10676
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Kifissia、ギリシャ、14561
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Patras、ギリシャ、26500
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Thessaloniki、ギリシャ、54642
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Alcira、スペイン、46600
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Barcelona、スペイン、08025
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Cadiz、スペイン、11009
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Madrid、スペイン、28046
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Sabadell、スペイン、08208
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Valencia、スペイン、46026
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Ceske Budejovice、チェコ、37005
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Klatovy、チェコ、33938
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Prague、チェコ、128 08
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Uherske Hradiste、チェコ、686 01
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Dresden、ドイツ、01067
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Frankfurt、ドイツ、60528
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Hamburg、ドイツ、22415
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Leipzig、ドイツ、04103
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Magdeburg、ドイツ、39110
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Marburg、ドイツ、35043
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Budapest、ハンガリー、1094
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Debrecen、ハンガリー、4043
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Eger、ハンガリー、3300
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Kaposvar、ハンガリー、7400
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Szeged、ハンガリー、6720
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Caen、フランス、14033
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La Crau、フランス、83260
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Lyon、フランス、69003
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Orleans、フランス、45032
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Saint-Etienne、フランス、42055
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Toulouse、フランス、31059
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Brasilia、ブラジル、71625-009
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Rio De Janeiro、ブラジル、22271-100
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São Paulo、ブラジル、05437-010
- 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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San Juan、プエルトリコ、00918
- 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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Brussels、ベルギー、1070
- 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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Genk、ベルギー、3600
- 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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Gent、ベルギー、9000
- 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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Gilly、ベルギー、6060
- 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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Laken、ベルギー、1020
- 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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Leuven、ベルギー、3000
- 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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Liège、ベルギー、4020
- 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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Merksem、ベルギー、2170
- 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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Mons、ベルギー、7000
- 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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Bialystok、ポーランド、15-351
- 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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Elblag、ポーランド、82-300
- 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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Lublin、ポーランド、20-582
- 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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Poznan、ポーランド、60-218
- 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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Swidnik、ポーランド、21-040
- 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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Warsaw、ポーランド、02-118
- 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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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
45年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
管理SC
他の名前：
経口投与
Teriparatide arm placebo administered orally. Risedronate arm placebo administered SC.
Administered orally
|
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アクティブコンパレータ：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. |
経口投与
経口投与
Teriparatide arm placebo administered orally. Risedronate arm placebo administered SC.
Administered orally
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of Participants With New Vertebral Fractures
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of Participants With Pooled New and Worsening Vertebral Fractures
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
|
Proportion of Participants With New Moderate and/or Severe Vertebral Fractures
時間枠：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
時間枠：Baseline through 24 Months
|
Baseline through 24 Months
|
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Proportion of Participants With Pooled Fragility and Traumatic Non-Vertebral Fractures
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
|
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Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (US)
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2012年10月1日
一次修了 (実際)
2016年7月1日
研究の完了 (実際)
2016年7月1日
試験登録日
最初に提出
2012年10月16日
QC基準を満たした最初の提出物
2012年10月16日
最初の投稿 (見積もり)
2012年10月17日
学習記録の更新
投稿された最後の更新 (実際)
2019年9月23日
QC基準を満たした最後の更新が送信されました
2019年9月9日
最終確認日
2019年9月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 14536
- B3D-EW-GHDW (その他の識別子：Eli Lilly and Company)
- 2012-000123-41 (EudraCT番号)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有時間枠
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 共有アクセス基準
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- CSR
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。