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Study · Randomized controlled trial · 2020

5 results

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.

Geusens P, Kendler DL, Fahrleitner-Pammer A, López-Romero P, Marin F

Calcified tissue international10 Mar 2020Cited by 6 (Europe PMC)

Summary

Vertebral fractures (VFx) occur most frequently in the mid-thoracic and thoraco-lumbar regions, which experience the highest mechanical loading along the spine. The prevalence and incidence of VFx by their location and severity, and their relationship with bone mineral density (BMD), are seldom reported in randomized clinical trial cohorts. The VERO trial randomized 1360 postmenopausal women with at least two moderate or one severe VFx to receive either teriparatide or risedronate for up to 24 months. In this post hoc analysis, we describe the centrally read distribution and severity of prevalent and incident VFx, and the association of their location with the baseline BMD. At baseline, 21.4% of all evaluable vertebral bodies had a prevalent VFx; most commonly at L1, T12, L2 and T11 (38.5%, 37.4%, 25.3% and 23.5% of patients, respectively). Patients with prevalent VFx only at T12/L1 showed a higher baseline BMD compared to patients with VFx at other levels. At month 24, 100 patients had 126 incident VFx (teriparatide: 35; risedronate: 91). The most frequent incident VFx occurred at T12 (n = 17, 1.6% of patients), followed by L1 and T11 (n = 14, 1.3% both). The frequency of incident VFx was lower at all vertebral levels in patients given teriparatide. These results confirm prior reports that VFx occurs more frequently at mid-thoracic and thoraco-lumbar regions of the spine. Patients with these VFx locations have higher BMD than those who fracture at other sites, suggesting a role for mechanical stress in the etiology of VFx. Teriparatide is superior to risedronate in the prevention of VFx at these common fracture locations.Trial registration ClinicalTrials.gov Identifier: NCT01709110.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study5

2 results from studies that gave the peptide. 2 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women with vertebral fractures, incident vertebral fractures numbered 35 with teriparatide and 91 with risedronate at month 24.

    In plain wordsIn postmenopausal women with vertebral fractures, teriparatide had fewer new vertebral fractures than risedronate.

    Outcome
    DecreaseIncident vertebral fracture count
    Study

    n: not reported in source

    Comparator
    Risedronate
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · up to 24 monthsAs given in this study (human).

    Measurements

    Incident vertebral fractures
    35 fractures
    teriparatide at month 24
    Incident vertebral fractures
    91 fractures
    risedronate at month 24

    Source sentences

    Summary
    At month 24, 100 patients had 126 incident VFx (teriparatide: 35; risedronate: 91).
    2 context sentences
    Summary · context
    The VERO trial randomized 1360 postmenopausal women with at least two moderate or one severe VFx to receive either teriparatide or risedronate for up to 24 months.
    Summary · context
    In this post hoc analysis, we describe the centrally read distribution and severity of prevalent and incident VFx, and the association of their location with the baseline BMD.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women with vertebral fractures, incident fracture frequency was lower at all vertebral levels with teriparatide than risedronate.

    In plain wordsIn postmenopausal women with vertebral fractures, teriparatide had fewer new fractures at all vertebral levels than risedronate.

    Outcome
    DecreaseIncident vertebral fracture frequency by vertebral level
    Study

    n: not reported in source

    Comparator
    Risedronate
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · up to 24 monthsAs given in this study (human).

    Source sentences

    Summary
    The frequency of incident VFx was lower at all vertebral levels in patients given teriparatide.
    2 context sentences
    Summary · context
    The VERO trial randomized 1360 postmenopausal women with at least two moderate or one severe VFx to receive either teriparatide or risedronate for up to 24 months.
    Summary · context
    In this post hoc analysis, we describe the centrally read distribution and severity of prevalent and incident VFx, and the association of their location with the baseline BMD.

Studies that did not test the peptide alone3

In this study, Teriparatide (PTH 1-34) was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Teriparatide (PTH 1-34).

  1. 03HumanNot a test of Teriparatide (PTH 1-34) aloneObservational studyOther

    In the pooled teriparatide-versus-risedronate trial cohort, prevalent fractures affected 21.4% of evaluable vertebral bodies and clustered at thoracolumbar levels.

    In plain wordsIn the pooled teriparatide-versus-risedronate trial cohort, existing vertebral fractures clustered near the junction of the thoracic and lumbar spine.

    Outcome
    Not applicableBaseline vertebral fracture prevalence and distribution
    Study

    n: not reported in source

    Outcome group
    Bone and joint · Musculoskeletal

    Measurements

    Prevalent vertebral fractures
    21.4%
    all evaluable vertebral bodies
    Prevalent fracture at L1
    38.5%
    patients
    Prevalent fracture at T12
    37.4%
    patients
    Prevalent fracture at L2
    25.3%
    patients
    Prevalent fracture at T11
    23.5%
    patients

    Source sentences

    Summary
    At baseline, 21.4% of all evaluable vertebral bodies had a prevalent VFx; most commonly at L1, T12, L2 and T11 (38.5%, 37.4%, 25.3% and 23.5% of patients, respectively).
    2 context sentences
    Summary · context
    The VERO trial randomized 1360 postmenopausal women with at least two moderate or one severe VFx to receive either teriparatide or risedronate for up to 24 months.
    Summary · context
    In this post hoc analysis, we describe the centrally read distribution and severity of prevalent and incident VFx, and the association of their location with the baseline BMD.

    In this study, Teriparatide (PTH 1-34) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Teriparatide (PTH 1-34).

  2. 04HumanNot a test of Teriparatide (PTH 1-34) aloneObservational studyOther

    In the pooled teriparatide-versus-risedronate cohort, baseline BMD was higher in patients with prevalent fractures only at T12/L1 than other levels.

    In plain wordsIn the pooled teriparatide-versus-risedronate cohort, baseline bone density was higher with fractures only at T12/L1 than at other levels.

    Outcome
    IncreaseBaseline BMD by prevalent fracture location
    Study

    n: not reported in source

    Comparator
    Patients with fractures at other levels
    Outcome group
    Bone and joint · Musculoskeletal

    Source sentences

    Summary
    Patients with prevalent VFx only at T12/L1 showed a higher baseline BMD compared to patients with VFx at other levels.
    2 context sentences
    Summary · context
    The VERO trial randomized 1360 postmenopausal women with at least two moderate or one severe VFx to receive either teriparatide or risedronate for up to 24 months.
    Summary · context
    In this post hoc analysis, we describe the centrally read distribution and severity of prevalent and incident VFx, and the association of their location with the baseline BMD.

    In this study, Teriparatide (PTH 1-34) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Teriparatide (PTH 1-34).

  3. 05HumanNot a test of Teriparatide (PTH 1-34) aloneObservational studyOther

    In the pooled teriparatide-versus-risedronate cohort, incident fractures occurred most frequently at T12, followed by L1 and T11.

    In plain wordsIn the pooled teriparatide-versus-risedronate cohort, new vertebral fractures occurred most frequently at T12, followed by L1 and T11.

    Outcome
    Not applicablePooled incident vertebral fracture distribution
    Study

    n: not reported in source

    Outcome group
    Bone and joint · Musculoskeletal

    Measurements

    Incident fractures at T12
    17 fractures
    pooled cohort
    Patients with incident fractures at T12
    1.6%
    pooled cohort
    Incident fractures at L1
    14 fractures
    pooled cohort
    Incident fractures at T11
    14 fractures
    pooled cohort
    Patients with incident fractures at L1
    1.3%
    pooled cohort
    Patients with incident fractures at T11
    1.3%
    pooled cohort

    Source sentences

    Summary
    The most frequent incident VFx occurred at T12 (n = 17, 1.6% of patients), followed by L1 and T11 (n = 14, 1.3% both).
    2 context sentences
    Summary · context
    The VERO trial randomized 1360 postmenopausal women with at least two moderate or one severe VFx to receive either teriparatide or risedronate for up to 24 months.
    Summary · context
    In this post hoc analysis, we describe the centrally read distribution and severity of prevalent and incident VFx, and the association of their location with the baseline BMD.

    In this study, Teriparatide (PTH 1-34) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Teriparatide (PTH 1-34).

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 4Results postedNCT01709110

VERtebral Fracture Treatment Comparisons in Osteoporotic Women

Eli Lilly and Companyn = 1,366Oct 2012 to Jul 2016

Postmenopausal Osteoporosis

Trial pageClinicalTrials.govUpdated 23 Sept 2019

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    22 Oct 2026, 02:26 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 18:59 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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