VERtebral Fracture Treatment Comparisons in Osteoporotic Women

Short name VERO

NCTNCT01709110Other id14536Other idB3D-EW-GHDWOther id2012-000123-41

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Overview

Status: Completed
Phase: Phase 4
Enrollment: 1,366 participants (actual)
Sponsor: Eli Lilly and Company · Industry
Design: Randomized · Quadruple masking
Countries: 15 countries
United States, Argentina, Austria, Belgium, Brazil, Canada, Czechia, France, Germany, Greece, Hungary, Italy, Poland, Puerto Rico, Spain
Start: Oct 2012
Primary completion: Jul 2016
Completion: Jul 2016
First posted: 17 Oct 2012 (estimated)
Last update posted: 23 Sept 2019
Conditions: Postmenopausal Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201220132014201520162017

Ph 4
VERO
NCT01709110
Oct 2012 to Jul 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

TeriparatideDrug
RisedronateDrug
PlaceboDrug
CalciumDrug
Vitamin DDrug

Arms2

Experimental
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.
Active comparator
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

Proportion of Participants With New Vertebral Fractures
Time frame · Baseline through 24 Months
Registry description
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 outcomes(11)

Proportion of Participants With Pooled New and Worsening Vertebral Fractures
Time frame · Baseline through 24 Months
Registry description
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
Time frame · Baseline through 24 Months
Registry description
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
Time frame · Baseline through 24 Months
Registry description
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
Time frame · Baseline through 24 Months
Registry description
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
Time frame · Baseline through 24 Months
Registry description
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
Time frame · Baseline through 24 Months
Proportion of Participants With Pooled Fragility and Traumatic Non-Vertebral Fractures
Time frame · Baseline through 24 Months
Registry 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.
Change From Baseline to 24 Months Endpoint in Height
Time frame · Baseline, 24 Months
Change From Baseline to 24 Months Endpoint in Back Pain Using an 11-point Numerical Pain Rating Scale
Time frame · Baseline, 24 Months
Registry description
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)
Time frame · Baseline, 24 Months
Registry 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 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)
Time frame · Baseline, 24 Months
Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Baseline through 24 Months