VERtebral Fracture Treatment Comparisons in Osteoporotic Women (VERO)
9 września 2019 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
1366
Faza
- Faza 4
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Buenos Aires, Argentyna, C1128AAF
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Caba, Argentyna, C1425AGC
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Mar Del Plata, Argentyna, 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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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, Brazylia, 71625-009
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Rio De Janeiro, Brazylia, 22271-100
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São Paulo, Brazylia, 05437-010
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Ceske Budejovice, Czechy, 37005
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Klatovy, Czechy, 33938
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Prague, Czechy, 128 08
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Uherske Hradiste, Czechy, 686 01
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Caen, Francja, 14033
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La Crau, Francja, 83260
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Lyon, Francja, 69003
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Orleans, Francja, 45032
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Saint-Etienne, Francja, 42055
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Toulouse, Francja, 31059
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Athens, Grecja, 10676
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Kifissia, Grecja, 14561
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Patras, Grecja, 26500
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Thessaloniki, Grecja, 54642
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Alcira, Hiszpania, 46600
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Barcelona, Hiszpania, 08025
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Cadiz, Hiszpania, 11009
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Madrid, Hiszpania, 28046
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Sabadell, Hiszpania, 08208
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Valencia, Hiszpania, 46026
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British Columbia
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Kelowna, British Columbia, Kanada, V1Y3G5
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Vancouver, British Columbia, Kanada, V5Z 4E1
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Nova Scotia
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Halifax, Nova Scotia, Kanada, B3H 1V7
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Ontario
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Hamilton, Ontario, Kanada, L8N 1Y2
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Toronto, Ontario, Kanada, M5G 2C4
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Quebec
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Montreal, Quebec, Kanada, H3T 1E2
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Sainte-Foy, Quebec, Kanada, G1V 3M7
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Trois-Rivieres, Quebec, Kanada, G8Z 1Y2
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Saskatchewan
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Saskatoon, Saskatchewan, Kanada, S7K 0H6
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Dresden, Niemcy, 01067
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Frankfurt, Niemcy, 60528
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Hamburg, Niemcy, 22415
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Leipzig, Niemcy, 04103
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Magdeburg, Niemcy, 39110
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Marburg, Niemcy, 35043
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Bialystok, Polska, 15-351
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Elblag, Polska, 82-300
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Lublin, Polska, 20-582
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Poznan, Polska, 60-218
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Swidnik, Polska, 21-040
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Warsaw, Polska, 02-118
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San Juan, Portoryko, 00918
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Alabama
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Birmingham, Alabama, Stany Zjednoczone, 35294
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California
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Concord, California, Stany Zjednoczone, 94520
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Fresno, California, Stany Zjednoczone, 93720
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Laguna Hills, California, Stany Zjednoczone, 92653
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Lancaster, California, Stany Zjednoczone, 93534
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Tustin, California, Stany Zjednoczone, 92780
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Colorado
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Lakewood, Colorado, Stany Zjednoczone, 80227
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Connecticut
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Danbury, Connecticut, Stany Zjednoczone, 06810
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Florida
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Orlando, Florida, Stany Zjednoczone, 32804
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Georgia
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Gainesville, Georgia, Stany Zjednoczone, 30501
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Indiana
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Evansville, Indiana, Stany Zjednoczone, 47714
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Indianapolis, Indiana, Stany Zjednoczone, 46202
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Kansas
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Topeka, Kansas, Stany Zjednoczone, 66606
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Maryland
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Bethesda, Maryland, Stany Zjednoczone, 20817
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Michigan
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Detroit, Michigan, Stany Zjednoczone, 48202
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Nebraska
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Omaha, Nebraska, Stany Zjednoczone, 68131
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New Jersey
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Clifton, New Jersey, Stany Zjednoczone, 07012
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Freehold, New Jersey, Stany Zjednoczone, 07728
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New Mexico
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Albuquerque, New Mexico, Stany Zjednoczone, 87106
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North Carolina
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Asheville, North Carolina, Stany Zjednoczone, 28803
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Greensboro, North Carolina, Stany Zjednoczone, 27408
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North Dakota
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Fargo, North Dakota, Stany Zjednoczone, 58103
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Oregon
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Bend, Oregon, Stany Zjednoczone, 97701
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Pennsylvania
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Duncansville, Pennsylvania, Stany Zjednoczone, 16635
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Pittsburgh, Pennsylvania, Stany Zjednoczone, 15213
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Wyomissing, Pennsylvania, Stany Zjednoczone, 19610
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Texas
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Dallas, Texas, Stany Zjednoczone, 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, Stany Zjednoczone, 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, Stany Zjednoczone, 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, Stany Zjednoczone, 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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Budapest, Węgry, 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, Węgry, 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, Węgry, 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, Węgry, 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, Węgry, 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, Włochy, 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, Włochy, 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, Włochy, 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, Włochy, 35128
- 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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Rome, Włochy, 00161
- 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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Torino, Włochy, 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, Włochy, 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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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
45 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Kobieta
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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. |
Administrowany SC
Inne nazwy:
Podawany doustnie
Teriparatide arm placebo administered orally. Risedronate arm placebo administered SC.
Administered orally
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Aktywny 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. |
Podawany doustnie
Podawany doustnie
Teriparatide arm placebo administered orally. Risedronate arm placebo administered SC.
Administered orally
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Proportion of Participants With New Vertebral Fractures
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Proportion of Participants With Pooled New and Worsening Vertebral Fractures
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 października 2012
Zakończenie podstawowe (Rzeczywisty)
1 lipca 2016
Ukończenie studiów (Rzeczywisty)
1 lipca 2016
Daty rejestracji na studia
Pierwszy przesłany
16 października 2012
Pierwszy przesłany, który spełnia kryteria kontroli jakości
16 października 2012
Pierwszy wysłany (Oszacować)
17 października 2012
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
23 września 2019
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
9 września 2019
Ostatnia weryfikacja
1 września 2019
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby metaboliczne
- Złamania, kości
- Rany i urazy
- Choroby układu mięśniowo-szkieletowego
- Choroby kości
- Choroby kości, metaboliczne
- Urazy kręgosłupa
- Urazy pleców
- Osteoporoza
- Osteoporoza, Postmenopauza
- Złamania kręgosłupa
- Fizjologiczne skutki leków
- Molekularne mechanizmy działania farmakologicznego
- Mikroelementy
- Modulatory transportu membranowego
- Witaminy
- Środki konserwujące gęstość kości
- Hormony i środki regulujące wapń
- Blokery kanału wapniowego
- Witamina D
- Wapń
- Teryparatyd
- Kwas ryzedronowy
Inne numery identyfikacyjne badania
- 14536
- B3D-EW-GHDW (Inny identyfikator: Eli Lilly and Company)
- 2012-000123-41 (Numer EudraCT)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu 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.
Ramy czasowe udostępniania 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.
Kryteria dostępu do udostępniania IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- CSR
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .