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VERtebral Fracture Treatment Comparisons in Osteoporotic Women (VERO)

Primary Purpose

Postmenopausal Osteoporosis

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Teriparatide

Risedronate

Placebo

Calcium

Vitamin D

About this trial

This is an interventional treatment trial for Postmenopausal Osteoporosis focused on measuring Bone Loss, Vertebral fractures

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Teriparatide

Risedronate

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Proportion of Participants With Pooled New and Worsening Vertebral Fractures

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).

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

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.

Proportion of Participants With Non-Vertebral Fragility Fractures

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.

Proportion of Participants With Major Non-Vertebral Fragility Fractures

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.

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

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).

Proportion of Participants With New Multiple (2 or More) Vertebral Fractures

Proportion of Participants With Pooled Fragility and Traumatic Non-Vertebral Fractures

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.

Change From Baseline to 24 Months Endpoint in Height

Change From Baseline to 24 Months Endpoint in Back Pain Using an 11-point Numerical Pain Rating Scale

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.

Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (UK)

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.

Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (US)

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.

Full Information

NCT ID

NCT01709110

First Posted

October 16, 2012

Last Updated

September 9, 2019

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01709110

Brief Title

VERtebral Fracture Treatment Comparisons in Osteoporotic Women

Acronym

VERO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postmenopausal Osteoporosis

Keywords

Bone Loss, Vertebral fractures

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1366 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Teriparatide

Arm Type

Experimental

Arm Description

Arm Title

Risedronate

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Teriparatide

Other Intervention Name(s)

LY333334, Forteo, Forsteo

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

Risedronate

Intervention Description

Administered orally

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Calcium

Intervention Description

Administered orally

Intervention Type

Drug

Intervention Name(s)

Vitamin D

Intervention Description

Administered orally

Primary Outcome Measure Information:

Title

Proportion of Participants With New Vertebral Fractures

Description

Time Frame

Baseline through 24 Months

Secondary Outcome Measure Information:

Title

Proportion of Participants With Pooled New and Worsening Vertebral Fractures

Description

Time Frame

Baseline through 24 Months

Title

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

Description

Time Frame

Baseline through 24 Months

Title

Proportion of Participants With Non-Vertebral Fragility Fractures

Description

Time Frame

Baseline through 24 Months

Title

Proportion of Participants With Major Non-Vertebral Fragility Fractures

Description

Time Frame

Baseline through 24 Months

Title

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

Description

Time Frame

Baseline through 24 Months

Title

Proportion of Participants With New Multiple (2 or More) Vertebral Fractures

Time Frame

Baseline through 24 Months

Title

Proportion of Participants With Pooled Fragility and Traumatic Non-Vertebral Fractures

Description

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.

Time Frame

Baseline through 24 Months

Title

Change From Baseline to 24 Months Endpoint in Height

Time Frame

Baseline, 24 Months

Title

Change From Baseline to 24 Months Endpoint in Back Pain Using an 11-point Numerical Pain Rating Scale

Description

Time Frame

Baseline, 24 Months

Title

Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (UK)

Description

Time Frame

Baseline, 24 Months

Title

Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (US)

Description

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.

Time Frame

Baseline, 24 Months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

City

Concord

State/Province

California

ZIP/Postal Code

94520

Country

United States

Facility Name

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

City

Laguna Hills

State/Province

California

ZIP/Postal Code

92653

Country

United States

Facility Name

City

Lancaster

State/Province

California

ZIP/Postal Code

93534

Country

United States

Facility Name

City

Tustin

State/Province

California

ZIP/Postal Code

92780

Country

United States

Facility Name

City

Lakewood

State/Province

Colorado

ZIP/Postal Code

80227

Country

United States

Facility Name

City

Danbury

State/Province

Connecticut

ZIP/Postal Code

06810

Country

United States

Facility Name

City

Orlando

State/Province

Florida

ZIP/Postal Code

32804

Country

United States

Facility Name

City

Gainesville

State/Province

Georgia

ZIP/Postal Code

30501

Country

United States

Facility Name

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47714

Country

United States

Facility Name

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66606

Country

United States

Facility Name

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20817

Country

United States

Facility Name

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

Facility Name

City

Clifton

State/Province

New Jersey

ZIP/Postal Code

07012

Country

United States

Facility Name

City

Freehold

State/Province

New Jersey

ZIP/Postal Code

07728

Country

United States

Facility Name

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87106

Country

United States

Facility Name

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28803

Country

United States

Facility Name

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27408

Country

United States

Facility Name

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58103

Country

United States

Facility Name

City

Bend

State/Province

Oregon

ZIP/Postal Code

97701

Country

United States

Facility Name

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

City

Wyomissing

State/Province

Pennsylvania

ZIP/Postal Code

19610

Country

United States

Facility Name

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

City

Seattle

State/Province

Washington

ZIP/Postal Code

98122

Country

United States

Facility Name

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53705

Country

United States

Facility Name

City

Buenos Aires

ZIP/Postal Code

C1128AAF

Country

Argentina

Facility Name

City

Caba

ZIP/Postal Code

C1425AGC

Country

Argentina

Facility Name

City

Mar Del Plata

ZIP/Postal Code

B7600DHK

Country

Argentina

Facility Name

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

City

Hohenems

ZIP/Postal Code

6845

Country

Austria

Facility Name

City

Linz

ZIP/Postal Code

4020

Country

Austria

Facility Name

City

Vienna

ZIP/Postal Code

A-1060

Country

Austria

Facility Name

City

Brussels

ZIP/Postal Code

1070

Country

Belgium

Facility Name

City

Genk

ZIP/Postal Code

3600

Country

Belgium

Facility Name

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

City

Gilly

ZIP/Postal Code

6060

Country

Belgium

Facility Name

City

Laken

ZIP/Postal Code

1020

Country

Belgium

Facility Name

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

City

Liège

ZIP/Postal Code

4020

Country

Belgium

Facility Name

City

Merksem

ZIP/Postal Code

2170

Country

Belgium

Facility Name

City

Mons

ZIP/Postal Code

7000

Country

Belgium

Facility Name

City

Brasilia

ZIP/Postal Code

71625-009

Country

Brazil

Facility Name

City

Rio De Janeiro

ZIP/Postal Code

22271-100

Country

Brazil

Facility Name

City

São Paulo

ZIP/Postal Code

05437-010

Country

Brazil

Facility Name

City

Kelowna

State/Province

British Columbia

ZIP/Postal Code

V1Y3G5

Country

Canada

Facility Name

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E1

Country

Canada

Facility Name

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 1V7

Country

Canada

Facility Name

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 1Y2

Country

Canada

Facility Name

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2C4

Country

Canada

Facility Name

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Facility Name

City

Sainte-Foy

State/Province

Quebec

ZIP/Postal Code

G1V 3M7

Country

Canada

Facility Name

City

Trois-Rivieres

State/Province

Quebec

ZIP/Postal Code

G8Z 1Y2

Country

Canada

Facility Name

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7K 0H6

Country

Canada

Facility Name

City

Ceske Budejovice

ZIP/Postal Code

37005

Country

Czechia

Facility Name

City

Klatovy

ZIP/Postal Code

33938

Country

Czechia

Facility Name

City

Prague

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

City

Uherske Hradiste

ZIP/Postal Code

686 01

Country

Czechia

Facility Name

City

Caen

ZIP/Postal Code

14033

Country

France

Facility Name

City

La Crau

ZIP/Postal Code

83260

Country

France

Facility Name

City

Lyon

ZIP/Postal Code

69003

Country

France

Facility Name

City

Orleans

ZIP/Postal Code

45032

Country

France

Facility Name

City

Saint-Etienne

ZIP/Postal Code

42055

Country

France

Facility Name

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

City

Dresden

ZIP/Postal Code

01067

Country

Germany

Facility Name

City

Frankfurt

ZIP/Postal Code

60528

Country

Germany

Facility Name

City

Hamburg

ZIP/Postal Code

22415

Country

Germany

Facility Name

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

City

Magdeburg

ZIP/Postal Code

39110

Country

Germany

Facility Name

City

Marburg

ZIP/Postal Code

35043

Country

Germany

Facility Name

City

Athens

ZIP/Postal Code

10676

Country

Greece

Facility Name

City

Kifissia

ZIP/Postal Code

14561

Country

Greece

Facility Name

City

Patras

ZIP/Postal Code

26500

Country

Greece

Facility Name

City

Thessaloniki

ZIP/Postal Code

54642

Country

Greece

Facility Name

City

Budapest

ZIP/Postal Code

1094

Country

Hungary

Facility Name

City

Debrecen

ZIP/Postal Code

4043

Country

Hungary

Facility Name

City

Eger

ZIP/Postal Code

3300

Country

Hungary

Facility Name

City

Kaposvar

ZIP/Postal Code

7400

Country

Hungary

Facility Name

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

Facility Name

City

Firenze

ZIP/Postal Code

50134

Country

Italy

Facility Name

City

Genova-Nervi

ZIP/Postal Code

16167

Country

Italy

Facility Name

City

Orbassano

ZIP/Postal Code

10043

Country

Italy

Facility Name

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

City

Rome

ZIP/Postal Code

00161

Country

Italy

Facility Name

City

Torino

ZIP/Postal Code

10126

Country

Italy

Facility Name

City

Valeggio Sul Mincio

ZIP/Postal Code

37067

Country

Italy

Facility Name

City

Bialystok

ZIP/Postal Code

15-351

Country

Poland

Facility Name

City

Elblag

ZIP/Postal Code

82-300

Country

Poland

Facility Name

City

Lublin

ZIP/Postal Code

20-582

Country

Poland

Facility Name

City

Poznan

ZIP/Postal Code

60-218

Country

Poland

Facility Name

City

Swidnik

ZIP/Postal Code

21-040

Country

Poland

Facility Name

City

Warsaw

ZIP/Postal Code

02-118

Country

Poland

Facility Name

City

San Juan

ZIP/Postal Code

00918

Country

Puerto Rico

Facility Name

City

Alcira

ZIP/Postal Code

46600

Country

Spain

Facility Name

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

City

Cadiz

ZIP/Postal Code

11009

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

City

Sabadell

ZIP/Postal Code

08208

Country

Spain

Facility Name

City

Valencia

ZIP/Postal Code

46026

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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 Sharing 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.

IPD Sharing Access Criteria

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

IPD Sharing URL

https://vivli.org/

Citations:

PubMed Identifier

32474650

Citation

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.

Results Reference

derived

PubMed Identifier

32157334

Citation

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.

Results Reference

derived

PubMed Identifier

30659410

Citation

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.

Results Reference

derived

PubMed Identifier

29329484

Citation

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.

Results Reference

derived

PubMed Identifier

29129436

Citation

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.

Results Reference

derived

Learn more about this trial

VERtebral Fracture Treatment Comparisons in Osteoporotic Women

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