VERtebral Fracture Treatment Comparisons in Osteoporotic Women (VERO)
9. september 2019 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
1366
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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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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Brussels, Belgia, 1070
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Genk, Belgia, 3600
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Gent, Belgia, 9000
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Gilly, Belgia, 6060
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Laken, Belgia, 1020
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Leuven, Belgia, 3000
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Liège, Belgia, 4020
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Merksem, Belgia, 2170
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Mons, Belgia, 7000
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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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British Columbia
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Kelowna, British Columbia, Canada, V1Y3G5
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Vancouver, British Columbia, Canada, V5Z 4E1
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
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Ontario
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Hamilton, Ontario, Canada, L8N 1Y2
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Toronto, Ontario, Canada, M5G 2C4
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Quebec
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Montreal, Quebec, Canada, H3T 1E2
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Sainte-Foy, Quebec, Canada, G1V 3M7
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Trois-Rivieres, Quebec, Canada, G8Z 1Y2
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7K 0H6
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Alabama
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Birmingham, Alabama, Forente stater, 35294
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California
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Concord, California, Forente stater, 94520
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Fresno, California, Forente stater, 93720
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Laguna Hills, California, Forente stater, 92653
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Lancaster, California, Forente stater, 93534
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Tustin, California, Forente stater, 92780
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Colorado
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Lakewood, Colorado, Forente stater, 80227
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Connecticut
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Danbury, Connecticut, Forente stater, 06810
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Florida
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Orlando, Florida, Forente stater, 32804
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Georgia
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Gainesville, Georgia, Forente stater, 30501
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Indiana
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Evansville, Indiana, Forente stater, 47714
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Indianapolis, Indiana, Forente stater, 46202
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Kansas
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Topeka, Kansas, Forente stater, 66606
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Maryland
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Bethesda, Maryland, Forente stater, 20817
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Michigan
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Detroit, Michigan, Forente stater, 48202
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Nebraska
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Omaha, Nebraska, Forente stater, 68131
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New Jersey
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Clifton, New Jersey, Forente stater, 07012
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Freehold, New Jersey, Forente stater, 07728
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New Mexico
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Albuquerque, New Mexico, Forente stater, 87106
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North Carolina
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Asheville, North Carolina, Forente stater, 28803
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Greensboro, North Carolina, Forente stater, 27408
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North Dakota
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Fargo, North Dakota, Forente stater, 58103
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Oregon
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Bend, Oregon, Forente stater, 97701
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Pennsylvania
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Duncansville, Pennsylvania, Forente stater, 16635
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Pittsburgh, Pennsylvania, Forente stater, 15213
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Wyomissing, Pennsylvania, Forente stater, 19610
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Texas
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Dallas, Texas, Forente stater, 75231
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Washington
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Seattle, Washington, Forente stater, 98122
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Spokane, Washington, Forente stater, 99204
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Wisconsin
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Madison, Wisconsin, Forente stater, 53705
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Caen, Frankrike, 14033
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La Crau, Frankrike, 83260
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Lyon, Frankrike, 69003
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Orleans, Frankrike, 45032
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Saint-Etienne, Frankrike, 42055
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Toulouse, Frankrike, 31059
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Athens, Hellas, 10676
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Kifissia, Hellas, 14561
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Patras, Hellas, 26500
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Thessaloniki, Hellas, 54642
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Firenze, Italia, 50134
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Genova-Nervi, Italia, 16167
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Orbassano, Italia, 10043
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Padova, Italia, 35128
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Rome, Italia, 00161
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Torino, Italia, 10126
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Valeggio Sul Mincio, Italia, 37067
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Bialystok, Polen, 15-351
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Elblag, Polen, 82-300
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Lublin, Polen, 20-582
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Poznan, Polen, 60-218
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Swidnik, Polen, 21-040
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Warsaw, Polen, 02-118
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San Juan, Puerto Rico, 00918
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Alcira, Spania, 46600
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Barcelona, Spania, 08025
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Cadiz, Spania, 11009
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Madrid, Spania, 28046
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Sabadell, Spania, 08208
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Valencia, Spania, 46026
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Ceske Budejovice, Tsjekkia, 37005
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Klatovy, Tsjekkia, 33938
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Prague, Tsjekkia, 128 08
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Uherske Hradiste, Tsjekkia, 686 01
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Dresden, Tyskland, 01067
- 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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Frankfurt, Tyskland, 60528
- 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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Hamburg, Tyskland, 22415
- 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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Leipzig, Tyskland, 04103
- 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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Magdeburg, Tyskland, 39110
- 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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Marburg, Tyskland, 35043
- 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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Budapest, Ungarn, 1094
- 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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Debrecen, Ungarn, 4043
- 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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Eger, Ungarn, 3300
- 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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Kaposvar, Ungarn, 7400
- 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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Szeged, Ungarn, 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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Graz, Østerrike, 8036
- 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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Hohenems, Østerrike, 6845
- 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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Linz, Østerrike, 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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Vienna, Østerrike, A-1060
- 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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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
45 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
Administrert SC
Andre navn:
Administrert oralt
Teriparatide arm placebo administered orally. Risedronate arm placebo administered SC.
Administered orally
|
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Aktiv komparator: 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. |
Administrert oralt
Administreres oralt
Teriparatide arm placebo administered orally. Risedronate arm placebo administered SC.
Administered orally
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Proportion of Participants With New Vertebral Fractures
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Proportion of Participants With Pooled New and Worsening Vertebral Fractures
Tidsramme: 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).
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Baseline through 24 Months
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Proportion of Participants With Pooled Clinical Vertebral and Non-Vertebral Fragility Fractures
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2012
Primær fullføring (Faktiske)
1. juli 2016
Studiet fullført (Faktiske)
1. juli 2016
Datoer for studieregistrering
Først innsendt
16. oktober 2012
Først innsendt som oppfylte QC-kriteriene
16. oktober 2012
Først lagt ut (Anslag)
17. oktober 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
23. september 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. september 2019
Sist bekreftet
1. september 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Metabolske sykdommer
- Brudd, bein
- Sår og skader
- Muskel- og skjelettsykdommer
- Beinsykdommer
- Bensykdommer, metabolske
- Spinalskader
- Ryggskader
- Osteoporose
- Osteoporose, postmenopausal
- Spinalfrakturer
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Mikronæringsstoffer
- Membrantransportmodulatorer
- Vitaminer
- Bone Density Conservation Agents
- Kalsiumregulerende hormoner og midler
- Kalsiumkanalblokkere
- Vitamin d
- Kalsium
- Teriparatid
- Risedronsyre
Andre studie-ID-numre
- 14536
- B3D-EW-GHDW (Annen identifikator: Eli Lilly and Company)
- 2012-000123-41 (EudraCT-nummer)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
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-delingstidsramme
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.
Tilgangskriterier for IPD-deling
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- CSR
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .