NCT01709110

Brief Summary

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
1,366

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2012

Longer than P75 for phase_4

Geographic Reach
15 countries

103 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

January 23, 2018

Completed
Last Updated

September 23, 2019

Status Verified

September 1, 2019

Enrollment Period

3.8 years

First QC Date

October 16, 2012

Results QC Date

July 13, 2017

Last Update Submit

September 9, 2019

Conditions

Postmenopausal Osteoporosis

Keywords

Bone LossVertebral fractures

Outcome Measures

Primary Outcomes (1)

  • Proportion of Participants With New Vertebral Fractures

    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

Secondary Outcomes (11)

  • Proportion of Participants With Pooled New and Worsening Vertebral Fractures

    Baseline through 24 Months

  • Proportion of Participants With Pooled Clinical Vertebral and Non-Vertebral Fragility Fractures

    Baseline through 24 Months

  • Proportion of Participants With Non-Vertebral Fragility Fractures

    Baseline through 24 Months

  • Proportion of Participants With Major Non-Vertebral Fragility Fractures

    Baseline through 24 Months

  • Proportion of Participants With New Moderate and/or Severe Vertebral Fractures

    Baseline through 24 Months

  • +6 more secondary outcomes

Study Arms (2)

Teriparatide

EXPERIMENTAL

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.

Drug: TeriparatideDrug: PlaceboDrug: CalciumDrug: Vitamin D

Risedronate

ACTIVE COMPARATOR

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.

Drug: RisedronateDrug: PlaceboDrug: CalciumDrug: Vitamin D

Interventions

TeriparatideDRUG

Administered SC

Also known as: LY333334, Forteo, Forsteo
Teriparatide
RisedronateDRUG

Administered orally

Risedronate
PlaceboDRUG

Teriparatide arm placebo administered orally. Risedronate arm placebo administered SC.

RisedronateTeriparatide
CalciumDRUG

Administered orally

RisedronateTeriparatide
Vitamin DDRUG

Administered orally

RisedronateTeriparatide

Eligibility Criteria

Age45 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (103)

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Birmingham, Alabama, 35294, United States

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Concord, California, 94520, United States

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Fresno, California, 93720, United States

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Laguna Hills, California, 92653, United States

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Lancaster, California, 93534, United States

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Tustin, California, 92780, United States

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Lakewood, Colorado, 80227, United States

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Danbury, Connecticut, 06810, United States

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Orlando, Florida, 32804, United States

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Gainesville, Georgia, 30501, United States

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Evansville, Indiana, 47714, United States

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Indianapolis, Indiana, 46202, United States

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Topeka, Kansas, 66606, United States

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Bethesda, Maryland, 20817, United States

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Detroit, Michigan, 48202, United States

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Omaha, Nebraska, 68131, United States

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Clifton, New Jersey, 07012, United States

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Freehold, New Jersey, 07728, United States

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Albuquerque, New Mexico, 87106, United States

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Asheville, North Carolina, 28803, United States

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Greensboro, North Carolina, 27408, United States

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Fargo, North Dakota, 58103, United States

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Bend, Oregon, 97701, United States

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Duncansville, Pennsylvania, 16635, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Wyomissing, Pennsylvania, 19610, United States

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Dallas, Texas, 75231, United States

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Seattle, Washington, 98122, United States

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Spokane, Washington, 99204, United States

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Madison, Wisconsin, 53705, United States

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Buenos Aires, C1128AAF, Argentina

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Caba, C1425AGC, Argentina

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Mar del Plata, B7600DHK, Argentina

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Graz, 8036, Austria

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Hohenems, 6845, Austria

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Linz, 4020, Austria

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Vienna, A-1060, Austria

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Brussels, 1070, Belgium

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Genk, 3600, Belgium

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Ghent, 9000, Belgium

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Gilly, 6060, Belgium

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Laken, 1020, Belgium

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Leuven, 3000, Belgium

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Liège, 4020, Belgium

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Merksem, 2170, Belgium

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Mons, 7000, Belgium

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Brasília, 71625-009, Brazil

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Rio de Janeiro, 22271-100, Brazil

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São Paulo, 05437-010, Brazil

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Kelowna, British Columbia, V1Y3G5, Canada

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Vancouver, British Columbia, V5Z 4E1, Canada

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Halifax, Nova Scotia, B3H 1V7, Canada

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Hamilton, Ontario, L8N 1Y2, Canada

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Toronto, Ontario, M5G 2C4, Canada

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Montreal, Quebec, H3T 1E2, Canada

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Sainte-Foy, Quebec, G1V 3M7, Canada

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Trois-Rivières, Quebec, G8Z 1Y2, Canada

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Saskatoon, Saskatchewan, S7K 0H6, Canada

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České Budějovice, 37005, Czechia

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Klatovy, 33938, Czechia

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Prague, 128 08, Czechia

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Uherské Hradiště, 686 01, Czechia

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Caen, 14033, France

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La Crau, 83260, France

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Lyon, 69003, France

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Orléans, 45032, France

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Saint-Etienne, 42055, France

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Toulouse, 31059, France

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Dresden, 01067, Germany

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Frankfurt, 60528, Germany

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Hamburg, 22415, Germany

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Leipzig, 04103, Germany

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Magdeburg, 39110, Germany

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Marburg, 35043, Germany

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Athens, 10676, Greece

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Kifissia, 14561, Greece

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Pátrai, 26500, Greece

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Thessaloniki, 54642, Greece

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Budapest, 1094, Hungary

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Debrecen, 4043, Hungary

Location

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Eger, 3300, Hungary

Location

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Kaposvár, 7400, Hungary

Location

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Szeged, 6720, Hungary

Location

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Florence, 50134, Italy

Location

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Genova-Nervi, 16167, Italy

Location

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Orbassano, 10043, Italy

Location

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Padua, 35128, Italy

Location

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Rome, 00161, Italy

Location

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Torino, 10126, Italy

Location

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Valeggio sul Mincio, 37067, Italy

Location

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Bialystok, 15-351, Poland

Location

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Elblag, 82-300, Poland

Location

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Lublin, 20-582, Poland

Location

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Poznan, 60-218, Poland

Location

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Świdnik, 21-040, Poland

Location

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Warsaw, 02-118, Poland

Location

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San Juan, 00918, Puerto Rico

Location

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Alzira, 46600, Spain

Location

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Barcelona, 08025, Spain

Location

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Cadiz, 11009, Spain

Location

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Madrid, 28046, Spain

Location

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Sabadell, 08208, Spain

Location

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Valencia, 46026, Spain

Location

Related Publications (5)

  • 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.

    PMID: 32474650DERIVED

  • 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.

    PMID: 32157334DERIVED

  • 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.

    PMID: 30659410DERIVED

  • 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.

    PMID: 29329484DERIVED

  • 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.

    PMID: 29129436DERIVED

MeSH Terms

Conditions

Osteoporosis, PostmenopausalBone Diseases, MetabolicSpinal Fractures

Interventions

TeriparatideRisedronic AcidCalciumVitamin D

Condition Hierarchy (Ancestors)

OsteoporosisBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesSpinal InjuriesBack InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

Parathyroid HormonePeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsDiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological FactorsSecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2012

First Posted

October 17, 2012

Study Start

October 1, 2012

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

September 23, 2019

Results First Posted

January 23, 2018

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
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.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
More information

Locations

HU(5)ES(6)BR(3)PR(1)PL(6)US(30)CZ(4)BE(9)AR(3)FR(6)CA(9)DE(6)GR(4)IT(7)AU(4)