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VERtebral Fracture Treatment Comparisons in Osteoporotic Women (VERO)

2019. szeptember 9. frissítette: 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.

A tanulmány áttekintése

Állapot

Befejezve

Körülmények

Postmenopauzális csontritkulás

Beavatkozás / kezelés

Tanulmány típusa

Beavatkozó

Beiratkozás (Tényleges)

1366

Fázis

4. fázis

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

Argentína
- - Buenos Aires, Argentína, C1128AAF
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  - Caba, Argentína, C1425AGC
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  - Mar Del Plata, Argentína, B7600DHK
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Ausztria
- - Graz, Ausztria, 8036
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  - Hohenems, Ausztria, 6845
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  - Linz, Ausztria, 4020
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  - Vienna, Ausztria, A-1060
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Belgium
- - Brussels, Belgium, 1070
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  - Genk, Belgium, 3600
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  - Gent, Belgium, 9000
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  - Gilly, Belgium, 6060
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  - Laken, Belgium, 1020
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  - Leuven, Belgium, 3000
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  - Liège, Belgium, 4020
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  - Merksem, Belgium, 2170
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  - Mons, Belgium, 7000
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Brazília
- - Brasilia, Brazília, 71625-009
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  - Rio De Janeiro, Brazília, 22271-100
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  - São Paulo, Brazília, 05437-010
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Csehország
- - Ceske Budejovice, Csehország, 37005
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  - Klatovy, Csehország, 33938
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  - Prague, Csehország, 128 08
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  - Uherske Hradiste, Csehország, 686 01
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Egyesült Államok
- Alabama
  - Birmingham, Alabama, Egyesült Államok, 35294
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- California
  - Concord, California, Egyesült Államok, 94520
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  - Fresno, California, Egyesült Államok, 93720
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  - Laguna Hills, California, Egyesült Államok, 92653
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  - Lancaster, California, Egyesült Államok, 93534
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  - Tustin, California, Egyesült Államok, 92780
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- Colorado
  - Lakewood, Colorado, Egyesült Államok, 80227
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- Connecticut
  - Danbury, Connecticut, Egyesült Államok, 06810
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- Florida
  - Orlando, Florida, Egyesült Államok, 32804
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- Georgia
  - Gainesville, Georgia, Egyesült Államok, 30501
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- Indiana
  - Evansville, Indiana, Egyesült Államok, 47714
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  - Indianapolis, Indiana, Egyesült Államok, 46202
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- Kansas
  - Topeka, Kansas, Egyesült Államok, 66606
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- Maryland
  - Bethesda, Maryland, Egyesült Államok, 20817
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- Michigan
  - Detroit, Michigan, Egyesült Államok, 48202
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- Nebraska
  - Omaha, Nebraska, Egyesült Államok, 68131
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- New Jersey
  - Clifton, New Jersey, Egyesült Államok, 07012
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  - Freehold, New Jersey, Egyesült Államok, 07728
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- New Mexico
  - Albuquerque, New Mexico, Egyesült Államok, 87106
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- North Carolina
  - Asheville, North Carolina, Egyesült Államok, 28803
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  - Greensboro, North Carolina, Egyesült Államok, 27408
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- North Dakota
  - Fargo, North Dakota, Egyesült Államok, 58103
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- Oregon
  - Bend, Oregon, Egyesült Államok, 97701
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- Pennsylvania
  - Duncansville, Pennsylvania, Egyesült Államok, 16635
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  - Pittsburgh, Pennsylvania, Egyesült Államok, 15213
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  - Wyomissing, Pennsylvania, Egyesült Államok, 19610
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- Texas
  - Dallas, Texas, Egyesült Államok, 75231
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- Washington
  - Seattle, Washington, Egyesült Államok, 98122
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  - Spokane, Washington, Egyesült Államok, 99204
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- Wisconsin
  - Madison, Wisconsin, Egyesült Államok, 53705
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Franciaország
- - Caen, Franciaország, 14033
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  - La Crau, Franciaország, 83260
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  - Lyon, Franciaország, 69003
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Orleans, Franciaország, 45032
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  - Saint-Etienne, Franciaország, 42055
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  - Toulouse, Franciaország, 31059
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Görögország
- - Athens, Görögország, 10676
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  - Kifissia, Görögország, 14561
    - 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.
  - Patras, Görögország, 26500
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  - Thessaloniki, Görögország, 54642
    - 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.
Kanada
- British Columbia
  - Kelowna, British Columbia, Kanada, V1Y3G5
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  - Vancouver, British Columbia, Kanada, V5Z 4E1
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- Nova Scotia
  - Halifax, Nova Scotia, Kanada, B3H 1V7
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- Ontario
  - Hamilton, Ontario, Kanada, L8N 1Y2
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  - Toronto, Ontario, Kanada, M5G 2C4
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- Quebec
  - 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
  - Saskatoon, Saskatchewan, Kanada, S7K 0H6
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Lengyelország
- - Bialystok, Lengyelország, 15-351
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  - Elblag, Lengyelország, 82-300
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  - Lublin, Lengyelország, 20-582
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  - Poznan, Lengyelország, 60-218
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  - Swidnik, Lengyelország, 21-040
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  - Warsaw, Lengyelország, 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.
Magyarország
- - Budapest, Magyarország, 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.
  - Debrecen, Magyarország, 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.
  - Eger, Magyarország, 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.
  - Kaposvar, Magyarország, 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.
  - Szeged, Magyarország, 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.
Németország
- - Dresden, Németország, 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.
  - Frankfurt, Németország, 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.
  - Hamburg, Németország, 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.
  - Leipzig, Németország, 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.
  - Magdeburg, Németország, 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.
  - Marburg, Németország, 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.
Olaszország
- - Firenze, Olaszország, 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.
  - Genova-Nervi, Olaszország, 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.
  - Orbassano, Olaszország, 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.
  - Padova, Olaszország, 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.
  - Rome, Olaszország, 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.
  - Torino, Olaszország, 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.
  - Valeggio Sul Mincio, Olaszország, 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.
Puerto Rico
- - 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.
Spanyolország
- - Alcira, Spanyolország, 46600
    - 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.
  - Barcelona, Spanyolország, 08025
    - 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.
  - Cadiz, Spanyolország, 11009
    - 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.
  - Madrid, Spanyolország, 28046
    - 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.
  - Sabadell, Spanyolország, 08208
    - 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.
  - Valencia, Spanyolország, 46026
    - 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.

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

45 év és régebbi (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Női

Leírás

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

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

Elsődleges cél: Kezelés
Kiosztás: Véletlenszerűsített
Beavatkozó modell: Párhuzamos hozzárendelés
Maszkolás: Négyszeres

Fegyverek száma

Fegyverek és beavatkozások

Résztvevő csoport / kar	Beavatkozás / kezelés
Kísérleti: 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.	Drog: Teriparatid SC beadva Más nevek: Forteo LY333334 Forsteo Drog: D-vitamin Orálisan beadva Drog: Placebo Teriparatide arm placebo administered orally. Risedronate arm placebo administered SC. Drog: Calcium Administered orally
Aktív összehasonlító: 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.	Drog: D-vitamin Orálisan beadva Drog: Risedronát Orálisan beadva Drog: Placebo Teriparatide arm placebo administered orally. Risedronate arm placebo administered SC. Drog: Calcium Administered orally

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő	Intézkedés leírása	Időkeret
Proportion of Participants With New Vertebral Fractures Időkeret: Baseline through 24 Months	The incidence of new vertebral fractures was assessed by quantitative vertebral morphometry measurements (QM) with qualitative visual semiquantitative grading (SQ) confirmation. A new vertebral fracture was diagnosed in a vertebra that was non-fractured at the baseline radiological examination. It was defined as a loss of vertebral body height of at least 20% and 4 mm from the baseline radiograph by vertebral QM, based upon placement of six points by a trained, central reader. Any fractures identified by QM were confirmed using SQ: if the vertebral body also had an increase of one or more severity grade, it was considered an incident vertebral fracture.	Baseline through 24 Months

Másodlagos eredményintézkedések

Eredménymérő	Intézkedés leírása	Időkeret
Proportion of Participants With Pooled New and Worsening Vertebral Fractures Időkeret: Baseline through 24 Months	Worsening of a pre-existing fracture was considered if the decrease in vertebral height was at least one severity grade in the semi-quantitative assessment, confirmed by a trained central reader, where vertebrae were graded as normal (SQ0) or as with mild (SQ1), moderate (SQ2), or severe (SQ3) fractures, defined as ~20 to 25% (mild), ~25 to 40% (moderate) or ~40% or more (severe) decrease in anterior, central, or posterior vertebral height (T4 to L4).	Baseline through 24 Months
Proportion of Participants With Pooled Clinical Vertebral and Non-Vertebral Fragility Fractures Időkeret: Baseline through 24 Months	A clinical vertebral fracture was defined as a new or worsening vertebral fracture, confirmed by radiography, that was associated with signs and symptoms highly suggestive of a vertebral fracture. All non-vertebral fractures that occurred and were diagnosed between visits required the confirmation by the site investigators after evaluating the original x-ray film(s), the radiology or surgical report. For clinical vertebral fractures, the final confirmation of the diagnosis required the centralized evaluation by a trained, independent reader.	Baseline through 24 Months
Proportion of Participants With Non-Vertebral Fragility Fractures Időkeret: Baseline through 24 Months	A non-vertebral fracture is a fracture at any of the following non-vertebral sites: clavicle, scapula, ribs, sternum, sacrum, coccyx, humerus, radius, ulna, carpus, pelvis, hip, femur, patella, tibia, fibula, ankle, calcaneus, tarsus, and metatarsal. Non-vertebral fractures were determined by direct questioning at each visit, and confirmed by the site investigators by x-ray, radiology or surgical report. Fractures resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving object were not considered fragility fractures but traumatic fractures.	Baseline through 24 Months
Proportion of Participants With Major Non-Vertebral Fragility Fractures Időkeret: Baseline through 24 Months	A major non-vertebral fracture is a fracture at any of the following non-vertebral sites hip, radius, humerus, ribs, pelvis, tibia and femur. Non-vertebral fractures were determined by direct questioning at each visit, and confirmed by the site investigators by x-ray, radiology or surgical report. Fractures resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving.	Baseline through 24 Months
Proportion of Participants With New Moderate and/or Severe Vertebral Fractures Időkeret: Baseline through 24 Months	Vertebrae were graded as moderate (SQ2), or severe (SQ3) fractures, based on ~25 to 40% (moderate) or ~40% or more (severe) decrease in anterior, central, or posterior vertebral height (T4 through L4).	Baseline through 24 Months
Proportion of Participants With New Multiple (2 or More) Vertebral Fractures Időkeret: Baseline through 24 Months		Baseline through 24 Months
Proportion of Participants With Pooled Fragility and Traumatic Non-Vertebral Fractures Időkeret: Baseline through 24 Months	Traumatic fractures were considered if resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving object.	Baseline through 24 Months
Change From Baseline to 24 Months Endpoint in Height Időkeret: Baseline, 24 Months		Baseline, 24 Months
Change From Baseline to 24 Months Endpoint in Back Pain Using an 11-point Numerical Pain Rating Scale Időkeret: Baseline, 24 Months	Participants rated the worst back pain during the 24 hours preceding the visit at baseline and each post-baseline visit. An 11-point numerical back pain rating scale (rated from 0 = no back pain to 10 = worst possible back pain) was used.	Baseline, 24 Months
Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (UK) Időkeret: Baseline, 24 Months	The EQ-5D-5L is a generic, multidimensional, health-related, quality-of-life instrument completed on five dimensions to measure health-related quality of life. The profile allowed participants to rate their health state in five health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a five level scale (no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems). The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.59 to 1.0. A higher score indicates better health state.	Baseline, 24 Months
Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (US) Időkeret: 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

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Eli Lilly and Company

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Általános kiadványok

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete

2012. október 1.

Elsődleges befejezés (Tényleges)

2016. július 1.

A tanulmány befejezése (Tényleges)

2016. július 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2012. október 16.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2012. október 16.

Első közzététel (Becslés)

2012. október 17.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2019. szeptember 23.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2019. szeptember 9.

Utolsó ellenőrzés

2019. szeptember 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

Egyéb vizsgálati azonosító számok

14536
B3D-EW-GHDW (Egyéb azonosító: Eli Lilly and Company)
2012-000123-41 (EudraCT szám)

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

IGEN

IPD terv leírása

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 megosztási időkeret

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD-megosztási hozzáférési feltételek

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Az IPD megosztását támogató információ típusa

STUDY_PROTOCOL
NEDV
CSR

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

Klinikai vizsgálatok a Postmenopauzális csontritkulás

Seoul National University Bundang Hospital
JW Pharmaceutical

Befejezve

A pitavastatin hatása a csontokra

Hiperkoleszterinémia | Osteoporosis, osteopenia | Menopauza osteoporosis

Koreai Köztársaság
Tufts University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Befejezve

A bikarbonát mozgásszervi hatásai

Esési sérülés | Izomvesztés | Törések | Osteoporosis, életkorral kapcsolatos

Egyesült Államok
Radius Health, Inc.

Befejezve

Az abaloparatid korai hatásai a csontképződés és -felszívódás szöveti alapú mutatóira

Csontritkulás | Csontritkulás kockázata | Csontritkulás, posztmenopauzás | Osteoporosis törés | Osteoporosis, életkorral összefüggő | A gerincre lokalizált csontritkulás | Szenilis csontritkulás | A csigolyák csontritkulása | Csontritkulás csigolya

Egyesült Államok
Ono Pharmaceutical Co. Ltd
Astellas Pharma Inc

Befejezve

Az ONO-5920 ellenőrzött vizsgálata involúciós osteoporosisban szenvedő betegeknél Japánban

Involúciós osteoporosis

Japán
Amgen

Befejezve

Egy tanulmány a romosozumab (AMG 785) biztonságosságának és hatékonyságának összehasonlítására a placebóval csontritkulásban szenvedő férfiaknál (BRIDGE)

Osteoporosis férfiaknál

Egyesült Államok, Belgium, Colombia, Csehország, Dánia, Japán, Mexikó, Lengyelország, Orosz Föderáció, Svájc
Mayo Clinic

Befejezve

A béta-blokkolók dózisválasza és receptorszelektivitása a csontanyagcserére

Osteoporosis, életkorral összefüggő

Egyesült Államok
Takeda
EA Pharma Co., Ltd.

Befejezve

II/III. fázis, kettős vak, párhuzamos csoportos összehasonlító vizsgálat az NE-58095 tabletták orális adagolásával kapcsolatban

Involúciós osteoporosis

Japán
Shanghai University of Traditional Chinese Medicine

Ismeretlen

Az elsődleges osteoporosis longitudinális vizsgálata Shanghai posztmenopauzás nőkben

Elsődleges osteoporosis

Kína
Ono Pharmaceutical Co. Ltd
Astellas Pharma Inc

Befejezve

Az ONO-5920 ellenőrzött vizsgálata involúciós osteoporosisban szenvedő betegeknél Japánban

Involúciós osteoporosis
Ono Pharmaceutical Co. Ltd

Befejezve

Az ONO-5920 ellenőrzött vizsgálata involúciós osteoporosisban szenvedő betegeknél Japánban

Involúciós osteoporosis

VERtebral Fracture Treatment Comparisons in Osteoporotic Women (VERO)

Teriparatide and Risedronate in the Treatment of Patients With Severe Postmenopausal Osteoporosis: Comparative Effects on Vertebral Fractures

A tanulmány áttekintése

Állapot

Körülmények

Beavatkozás / kezelés

Tanulmány típusa

Beiratkozás (Tényleges)

Fázis

Kapcsolatok és helyek

Tanulmányi helyek

Részvételi kritériumok

Jogosultsági kritériumok

Tanulmányozható életkorok

Egészséges önkénteseket fogad

Tanulmányozható nemek

Leírás

Tanulási terv

Hogyan készül a tanulmány?

Tervezési részletek

Fegyverek száma

Fegyverek és beavatkozások

Résztvevő csoport / kar

Beavatkozás / kezelés

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő

Intézkedés leírása

Időkeret

Másodlagos eredményintézkedések

Eredménymérő

Intézkedés leírása

Időkeret

Együttműködők és nyomozók

Szponzor

Publikációk és hasznos linkek

Általános kiadványok

Tanulmányi rekorddátumok

Tanulmány főbb dátumok

Tanulmány kezdete

Elsődleges befejezés (Tényleges)

A tanulmány befejezése (Tényleges)

Tanulmányi regisztráció dátumai

Először benyújtva

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

Első közzététel (Becslés)

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

Utolsó ellenőrzés

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

IPD terv leírása

IPD megosztási időkeret

IPD-megosztási hozzáférési feltételek

Az IPD megosztását támogató információ típusa

Klinikai vizsgálatok a Postmenopauzális csontritkulás

Keressen hasonló próbaverziókban

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

CROs by country

CROs in Croatia

Körülmények

Ritka betegségek

Kábítószer-beavatkozások

Táplálék-kiegészítők

Szponzor / közreműködők

Helyek