VERtebral Fracture Treatment Comparisons in Osteoporotic Women (VERO)
9 сентября 2019 г. обновлено: 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.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Действительный)
1366
Фаза
- Фаза 4
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Graz, Австрия, 8036
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Hohenems, Австрия, 6845
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Linz, Австрия, 4020
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Vienna, Австрия, A-1060
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Buenos Aires, Аргентина, C1128AAF
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Caba, Аргентина, C1425AGC
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Mar Del Plata, Аргентина, B7600DHK
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Brussels, Бельгия, 1070
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Genk, Бельгия, 3600
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Gent, Бельгия, 9000
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Gilly, Бельгия, 6060
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Laken, Бельгия, 1020
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Leuven, Бельгия, 3000
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Liège, Бельгия, 4020
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Merksem, Бельгия, 2170
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Mons, Бельгия, 7000
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Brasilia, Бразилия, 71625-009
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Rio De Janeiro, Бразилия, 22271-100
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São Paulo, Бразилия, 05437-010
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Budapest, Венгрия, 1094
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Debrecen, Венгрия, 4043
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Eger, Венгрия, 3300
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Kaposvar, Венгрия, 7400
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Szeged, Венгрия, 6720
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Dresden, Германия, 01067
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Frankfurt, Германия, 60528
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Hamburg, Германия, 22415
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Leipzig, Германия, 04103
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Magdeburg, Германия, 39110
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Marburg, Германия, 35043
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Athens, Греция, 10676
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Kifissia, Греция, 14561
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Patras, Греция, 26500
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Thessaloniki, Греция, 54642
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Alcira, Испания, 46600
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Barcelona, Испания, 08025
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Cadiz, Испания, 11009
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Madrid, Испания, 28046
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Sabadell, Испания, 08208
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Valencia, Испания, 46026
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Firenze, Италия, 50134
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Genova-Nervi, Италия, 16167
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Orbassano, Италия, 10043
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Padova, Италия, 35128
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Rome, Италия, 00161
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Torino, Италия, 10126
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Valeggio Sul Mincio, Италия, 37067
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British Columbia
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Kelowna, British Columbia, Канада, V1Y3G5
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Vancouver, British Columbia, Канада, V5Z 4E1
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Nova Scotia
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Halifax, Nova Scotia, Канада, B3H 1V7
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Ontario
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Hamilton, Ontario, Канада, L8N 1Y2
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Toronto, Ontario, Канада, M5G 2C4
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Quebec
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Montreal, Quebec, Канада, H3T 1E2
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Sainte-Foy, Quebec, Канада, G1V 3M7
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Trois-Rivieres, Quebec, Канада, G8Z 1Y2
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Saskatchewan
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Saskatoon, Saskatchewan, Канада, S7K 0H6
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Bialystok, Польша, 15-351
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Elblag, Польша, 82-300
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Lublin, Польша, 20-582
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Poznan, Польша, 60-218
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Swidnik, Польша, 21-040
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Warsaw, Польша, 02-118
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San Juan, Пуэрто-Рико, 00918
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Alabama
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Birmingham, Alabama, Соединенные Штаты, 35294
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California
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Concord, California, Соединенные Штаты, 94520
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Fresno, California, Соединенные Штаты, 93720
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Laguna Hills, California, Соединенные Штаты, 92653
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Lancaster, California, Соединенные Штаты, 93534
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Tustin, California, Соединенные Штаты, 92780
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Colorado
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Lakewood, Colorado, Соединенные Штаты, 80227
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Connecticut
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Danbury, Connecticut, Соединенные Штаты, 06810
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Florida
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Orlando, Florida, Соединенные Штаты, 32804
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Georgia
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Gainesville, Georgia, Соединенные Штаты, 30501
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Indiana
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Evansville, Indiana, Соединенные Штаты, 47714
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Indianapolis, Indiana, Соединенные Штаты, 46202
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Kansas
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Topeka, Kansas, Соединенные Штаты, 66606
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Maryland
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Bethesda, Maryland, Соединенные Штаты, 20817
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Michigan
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Detroit, Michigan, Соединенные Штаты, 48202
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Nebraska
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Omaha, Nebraska, Соединенные Штаты, 68131
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New Jersey
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Clifton, New Jersey, Соединенные Штаты, 07012
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Freehold, New Jersey, Соединенные Штаты, 07728
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New Mexico
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Albuquerque, New Mexico, Соединенные Штаты, 87106
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North Carolina
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Asheville, North Carolina, Соединенные Штаты, 28803
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Greensboro, North Carolina, Соединенные Штаты, 27408
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North Dakota
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Fargo, North Dakota, Соединенные Штаты, 58103
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Oregon
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Bend, Oregon, Соединенные Штаты, 97701
- 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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Pennsylvania
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Duncansville, Pennsylvania, Соединенные Штаты, 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, Соединенные Штаты, 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, Соединенные Штаты, 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, Соединенные Штаты, 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, Соединенные Штаты, 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, Соединенные Штаты, 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, Соединенные Штаты, 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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Caen, Франция, 14033
- 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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La Crau, Франция, 83260
- 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.
-
Lyon, Франция, 69003
- 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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Orleans, Франция, 45032
- 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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Saint-Etienne, Франция, 42055
- 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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Toulouse, Франция, 31059
- 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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Ceske Budejovice, Чехия, 37005
- 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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Klatovy, Чехия, 33938
- 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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Prague, Чехия, 128 08
- 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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Uherske Hradiste, Чехия, 686 01
- 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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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
45 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Женский
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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. |
Администрируемый SC
Другие имена:
Вводится перорально
Teriparatide arm placebo administered orally. Risedronate arm placebo administered SC.
Administered orally
|
|
Активный компаратор: 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. |
Вводится перорально
Вводится перорально
Teriparatide arm placebo administered orally. Risedronate arm placebo administered SC.
Administered orally
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Proportion of Participants With New Vertebral Fractures
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Proportion of Participants With Pooled New and Worsening Vertebral Fractures
Временное ограничение: 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
|
|
Proportion of Participants With Pooled Clinical Vertebral and Non-Vertebral Fragility Fractures
Временное ограничение: 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
Временное ограничение: 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
|
|
Proportion of Participants With Major Non-Vertebral Fragility Fractures
Временное ограничение: 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
Временное ограничение: 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
|
|
Proportion of Participants With New Multiple (2 or More) Vertebral Fractures
Временное ограничение: Baseline through 24 Months
|
Baseline through 24 Months
|
|
|
Proportion of Participants With Pooled Fragility and Traumatic Non-Vertebral Fractures
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
|
Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (UK)
Временное ограничение: 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)
Временное ограничение: 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
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- 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.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 октября 2012 г.
Первичное завершение (Действительный)
1 июля 2016 г.
Завершение исследования (Действительный)
1 июля 2016 г.
Даты регистрации исследования
Первый отправленный
16 октября 2012 г.
Впервые представлено, что соответствует критериям контроля качества
16 октября 2012 г.
Первый опубликованный (Оценивать)
17 октября 2012 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
23 сентября 2019 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
9 сентября 2019 г.
Последняя проверка
1 сентября 2019 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Метаболические заболевания
- Переломы, Кость
- Раны и травмы
- Заболевания опорно-двигательного аппарата
- Заболевания костей
- Болезни костей, метаболические
- Травмы позвоночника
- Травмы спины
- Остеопороз
- Остеопороз, постменопауза
- Переломы позвоночника
- Физиологические эффекты лекарств
- Молекулярные механизмы фармакологического действия
- Микроэлементы
- Модуляторы мембранного транспорта
- Витамины
- Агенты сохранения плотности костей
- Кальций-регулирующие гормоны и агенты
- Блокаторы кальциевых каналов
- Витамин Д
- Кальций
- Терипаратид
- Ризедроновая кислота
Другие идентификационные номера исследования
- 14536
- B3D-EW-GHDW (Другой идентификатор: Eli Lilly and Company)
- 2012-000123-41 (Номер EudraCT)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
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.
Сроки обмена IPD
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.
Критерии совместного доступа к IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- КСО
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .