VERtebral Fracture Treatment Comparisons in Osteoporotic Women (VERO)
9 de septiembre de 2019 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
1366
Fase
- Fase 4
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Dresden, Alemania, 01067
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Frankfurt, Alemania, 60528
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Hamburg, Alemania, 22415
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Leipzig, Alemania, 04103
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Magdeburg, Alemania, 39110
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Marburg, Alemania, 35043
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Buenos Aires, Argentina, C1128AAF
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Caba, Argentina, C1425AGC
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Mar Del Plata, Argentina, B7600DHK
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Graz, Austria, 8036
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Hohenems, Austria, 6845
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Linz, Austria, 4020
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Vienna, Austria, A-1060
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Brasilia, Brasil, 71625-009
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Rio De Janeiro, Brasil, 22271-100
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São Paulo, Brasil, 05437-010
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Brussels, Bélgica, 1070
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Genk, Bélgica, 3600
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Gent, Bélgica, 9000
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Gilly, Bélgica, 6060
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Laken, Bélgica, 1020
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Leuven, Bélgica, 3000
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Liège, Bélgica, 4020
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Merksem, Bélgica, 2170
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Mons, Bélgica, 7000
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British Columbia
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Kelowna, British Columbia, Canadá, V1Y3G5
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Vancouver, British Columbia, Canadá, V5Z 4E1
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Nova Scotia
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Halifax, Nova Scotia, Canadá, B3H 1V7
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Ontario
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Hamilton, Ontario, Canadá, L8N 1Y2
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Toronto, Ontario, Canadá, M5G 2C4
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Quebec
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Montreal, Quebec, Canadá, H3T 1E2
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Sainte-Foy, Quebec, Canadá, G1V 3M7
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Trois-Rivieres, Quebec, Canadá, G8Z 1Y2
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Saskatchewan
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Saskatoon, Saskatchewan, Canadá, S7K 0H6
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Ceske Budejovice, Chequia, 37005
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Klatovy, Chequia, 33938
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Prague, Chequia, 128 08
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Uherske Hradiste, Chequia, 686 01
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Alcira, España, 46600
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Barcelona, España, 08025
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Cadiz, España, 11009
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Madrid, España, 28046
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Sabadell, España, 08208
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Valencia, España, 46026
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
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California
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Concord, California, Estados Unidos, 94520
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Fresno, California, Estados Unidos, 93720
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Laguna Hills, California, Estados Unidos, 92653
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Lancaster, California, Estados Unidos, 93534
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Tustin, California, Estados Unidos, 92780
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Colorado
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Lakewood, Colorado, Estados Unidos, 80227
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Connecticut
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Danbury, Connecticut, Estados Unidos, 06810
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Florida
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Orlando, Florida, Estados Unidos, 32804
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Georgia
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Gainesville, Georgia, Estados Unidos, 30501
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Indiana
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Evansville, Indiana, Estados Unidos, 47714
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Indianapolis, Indiana, Estados Unidos, 46202
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Kansas
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Topeka, Kansas, Estados Unidos, 66606
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Maryland
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Bethesda, Maryland, Estados Unidos, 20817
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Michigan
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Detroit, Michigan, Estados Unidos, 48202
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68131
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New Jersey
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Clifton, New Jersey, Estados Unidos, 07012
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Freehold, New Jersey, Estados Unidos, 07728
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87106
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North Carolina
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Asheville, North Carolina, Estados Unidos, 28803
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Greensboro, North Carolina, Estados Unidos, 27408
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North Dakota
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Fargo, North Dakota, Estados Unidos, 58103
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Oregon
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Bend, Oregon, Estados Unidos, 97701
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Pennsylvania
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Duncansville, Pennsylvania, Estados Unidos, 16635
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
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Wyomissing, Pennsylvania, Estados Unidos, 19610
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Texas
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Dallas, Texas, Estados Unidos, 75231
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Washington
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Seattle, Washington, Estados Unidos, 98122
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Spokane, Washington, Estados Unidos, 99204
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53705
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Caen, Francia, 14033
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La Crau, Francia, 83260
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Lyon, Francia, 69003
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Orleans, Francia, 45032
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Saint-Etienne, Francia, 42055
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Toulouse, Francia, 31059
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Athens, Grecia, 10676
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Kifissia, Grecia, 14561
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Patras, Grecia, 26500
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Thessaloniki, Grecia, 54642
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Budapest, Hungría, 1094
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Debrecen, Hungría, 4043
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Eger, Hungría, 3300
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Kaposvar, Hungría, 7400
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Szeged, Hungría, 6720
- 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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Firenze, Italia, 50134
- 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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Genova-Nervi, Italia, 16167
- 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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Orbassano, Italia, 10043
- 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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Padova, Italia, 35128
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Rome, Italia, 00161
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Torino, Italia, 10126
- 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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Valeggio Sul Mincio, Italia, 37067
- 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, Polonia, 15-351
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Elblag, Polonia, 82-300
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Lublin, Polonia, 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, Polonia, 60-218
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Swidnik, Polonia, 21-040
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Warsaw, Polonia, 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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San Juan, Puerto Rico, 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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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
45 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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. |
CS administrado
Otros nombres:
Administrado por vía oral
Teriparatide arm placebo administered orally. Risedronate arm placebo administered SC.
Administered orally
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Comparador activo: 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. |
Administrado por vía oral
Administrado por vía oral
Teriparatide arm placebo administered orally. Risedronate arm placebo administered SC.
Administered orally
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of Participants With New Vertebral Fractures
Periodo de tiempo: Baseline through 24 Months
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of Participants With Pooled New and Worsening Vertebral Fractures
Periodo de tiempo: Baseline through 24 Months
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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).
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Baseline through 24 Months
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Proportion of Participants With Pooled Clinical Vertebral and Non-Vertebral Fragility Fractures
Periodo de tiempo: Baseline through 24 Months
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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
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Proportion of Participants With Non-Vertebral Fragility Fractures
Periodo de tiempo: Baseline through 24 Months
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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.
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Baseline through 24 Months
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Proportion of Participants With Major Non-Vertebral Fragility Fractures
Periodo de tiempo: Baseline through 24 Months
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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.
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Baseline through 24 Months
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Proportion of Participants With New Moderate and/or Severe Vertebral Fractures
Periodo de tiempo: Baseline through 24 Months
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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).
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Baseline through 24 Months
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Proportion of Participants With New Multiple (2 or More) Vertebral Fractures
Periodo de tiempo: Baseline through 24 Months
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Baseline through 24 Months
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Proportion of Participants With Pooled Fragility and Traumatic Non-Vertebral Fractures
Periodo de tiempo: Baseline through 24 Months
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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.
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Baseline through 24 Months
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Change From Baseline to 24 Months Endpoint in Height
Periodo de tiempo: Baseline, 24 Months
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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
Periodo de tiempo: Baseline, 24 Months
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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.
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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)
Periodo de tiempo: Baseline, 24 Months
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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.
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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)
Periodo de tiempo: 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.
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Baseline, 24 Months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de octubre de 2012
Finalización primaria (Actual)
1 de julio de 2016
Finalización del estudio (Actual)
1 de julio de 2016
Fechas de registro del estudio
Enviado por primera vez
16 de octubre de 2012
Primero enviado que cumplió con los criterios de control de calidad
16 de octubre de 2012
Publicado por primera vez (Estimar)
17 de octubre de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
23 de septiembre de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
9 de septiembre de 2019
Última verificación
1 de septiembre de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades metabólicas
- Fracturas, Hueso
- Heridas y Lesiones
- Enfermedades musculoesqueléticas
- Enfermedades óseas
- Enfermedades Óseas Metabólicas
- Lesiones de la médula
- Lesiones de espalda
- Osteoporosis
- Osteoporosis Posmenopáusica
- Fracturas de columna
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Micronutrientes
- Moduladores de transporte de membrana
- Vitaminas
- Agentes de conservación de la densidad ósea
- Hormonas y agentes reguladores del calcio
- Bloqueadores de los canales de calcio
- Vitamina D
- Calcio
- Teriparatida
- Ácido risedrónico
Otros números de identificación del estudio
- 14536
- B3D-EW-GHDW (Otro identificador: Eli Lilly and Company)
- 2012-000123-41 (Número EudraCT)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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.
Marco de tiempo para compartir 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.
Criterios de acceso compartido de IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- RSC
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .