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Study · Randomized controlled trial · n = 92 · 2013

7 results

Comparative effects of teriparatide and risedronate in glucocorticoid-induced osteoporosis in men: 18-month results of the EuroGIOPs trial.

Glüer CC, Marin F, Ringe JD, Hawkins F, Möricke R, Papaioannu N, Farahmand P, Minisola S, Martínez G, Nolla JM, Niedhart C, Guañabens N and 10 more

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Nuti R, Martín-Mola E, Thomasius F, Kapetanos G, Peña J, Graeff C, Petto H, Sanz B, Reisinger A, Zysset PK

Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research1 Jun 2013Cited by 108 (Europe PMC)

Summary

Data on treatment of glucocorticoid-induced osteoporosis (GIO) in men are scarce. We performed a randomized, open-label trial in men who have taken glucocorticoids (GC) for ≥3 months, and had an areal bone mineral density (aBMD) T-score ≤ -1.5 standard deviations. Subjects received 20 μg/d teriparatide (n = 45) or 35 mg/week risedronate (n = 47) for 18 months. Primary objective was to compare lumbar spine (L1 -L3 ) BMD measured by quantitative computed tomography (QCT). Secondary outcomes included BMD and microstructure measured by high-resolution QCT (HRQCT) at the 12th thoracic vertebra, biomechanical effects for axial compression, anterior bending, and axial torsion evaluated by finite element (FE) analysis from HRQCT data, aBMD by dual X-ray absorptiometry, biochemical markers, and safety. Computed tomography scans were performed at 0, 6, and 18 months. A mixed model repeated measures analysis was performed to compare changes from baseline between groups. Mean age was 56.3 years. Median GC dose and duration were 8.8 mg/d and 6.4 years, respectively; 39.1% of subjects had a prevalent fracture, and 32.6% received prior bisphosphonate treatment. At 18 months, trabecular BMD had significantly increased for both treatments, with significantly greater increases with teriparatide (16.3% versus 3.8%; p = 0.004). HRQCT trabecular and cortical variables significantly increased for both treatments with significantly larger improvements for teriparatide for integral and trabecular BMD and bone surface to volume ratio (BS/BV) as a microstructural measure. Vertebral strength increases at 18 months were significant in both groups (teriparatide: 26.0% to 34.0%; risedronate: 4.2% to 6.7%), with significantly higher increases in the teriparatide group for all loading modes (0.005 < p < 0.015). Adverse events were similar between groups. None of the patients on teriparatide but five (10.6%) on risedronate developed new clinical fractures (p = 0.056). In conclusion, in this 18-month trial in men with GIO, teriparatide showed larger improvements in spinal BMD, microstructure, and FE-derived strength than risedronate.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In men with glucocorticoid-induced osteoporosis, teriparatide increased HRQCT integral BMD more than risedronate.

    In plain wordsIn men with glucocorticoid-induced osteoporosis, teriparatide increased integral bone density more than risedronate.

    Outcome
    IncreaseIntegral BMD
    Study

    n = 92

    Comparator
    Risedronate
    Analysis
    Secondary
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 μg/day · 18 monthsAs given in this study (human).

    Source sentences

    Summary
    HRQCT trabecular and cortical variables significantly increased for both treatments with significantly larger improvements for teriparatide for integral and trabecular BMD and bone surface to volume ratio (BS/BV) as a microstructural measure.
    2 context sentences
    Summary · context
    We performed a randomized, open-label trial in men who have taken glucocorticoids (GC) for ≥3 months, and had an areal bone mineral density (aBMD) T-score ≤ -1.5 standard deviations.
    Summary · context
    Subjects received 20 μg/d teriparatide (n = 45) or 35 mg/week risedronate (n = 47) for 18 months.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In men with glucocorticoid-induced osteoporosis, teriparatide increased HRQCT trabecular BMD more than risedronate.

    In plain wordsIn men with glucocorticoid-induced osteoporosis, teriparatide increased trabecular bone density more than risedronate.

    Outcome
    IncreaseHRQCT trabecular BMD
    Study

    n = 92

    Comparator
    Risedronate
    Analysis
    Secondary
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 μg/day · 18 monthsAs given in this study (human).

    Source sentences

    Summary
    HRQCT trabecular and cortical variables significantly increased for both treatments with significantly larger improvements for teriparatide for integral and trabecular BMD and bone surface to volume ratio (BS/BV) as a microstructural measure.
    2 context sentences
    Summary · context
    We performed a randomized, open-label trial in men who have taken glucocorticoids (GC) for ≥3 months, and had an areal bone mineral density (aBMD) T-score ≤ -1.5 standard deviations.
    Summary · context
    Subjects received 20 μg/d teriparatide (n = 45) or 35 mg/week risedronate (n = 47) for 18 months.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In men with glucocorticoid-induced osteoporosis, teriparatide improved bone surface to volume ratio more than risedronate.

    In plain wordsIn men with glucocorticoid-induced osteoporosis, teriparatide improved bone surface to volume ratio more than risedronate.

    Outcome
    Direction not reportedBone surface to volume ratio
    Study

    n = 92

    Comparator
    Risedronate
    Analysis
    Secondary
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 μg/day · 18 monthsAs given in this study (human).

    Source sentences

    Summary
    HRQCT trabecular and cortical variables significantly increased for both treatments with significantly larger improvements for teriparatide for integral and trabecular BMD and bone surface to volume ratio (BS/BV) as a microstructural measure.
    2 context sentences
    Summary · context
    We performed a randomized, open-label trial in men who have taken glucocorticoids (GC) for ≥3 months, and had an areal bone mineral density (aBMD) T-score ≤ -1.5 standard deviations.
    Summary · context
    Subjects received 20 μg/d teriparatide (n = 45) or 35 mg/week risedronate (n = 47) for 18 months.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In men with glucocorticoid-induced osteoporosis, teriparatide increased vertebral strength more than risedronate across all loading modes.

    In plain wordsIn men with glucocorticoid-induced osteoporosis, teriparatide increased vertebral strength more than risedronate across all tested loading modes.

    Outcome
    IncreaseVertebral strength across loading modes
    Study

    n = 92

    Comparator
    Risedronate
    Analysis
    Secondary
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 μg/day · 18 monthsAs given in this study (human).

    Measurements

    Vertebral strength increase
    26 to 34%
    teriparatide
    Vertebral strength increase
    4.2 to 6.7%
    risedronate

    Source sentences

    Summary
    Vertebral strength increases at 18 months were significant in both groups (teriparatide: 26.0% to 34.0%; risedronate: 4.2% to 6.7%), with significantly higher increases in the teriparatide group for all loading modes (0.005 < p < 0.015).
    2 context sentences
    Summary · context
    We performed a randomized, open-label trial in men who have taken glucocorticoids (GC) for ≥3 months, and had an areal bone mineral density (aBMD) T-score ≤ -1.5 standard deviations.
    Summary · context
    Subjects received 20 μg/d teriparatide (n = 45) or 35 mg/week risedronate (n = 47) for 18 months.
  5. 05HumanRandomized controlled trialSafety outcome

    In men with glucocorticoid-induced osteoporosis, adverse events were similar with teriparatide and risedronate.

    In plain wordsIn men with glucocorticoid-induced osteoporosis, adverse events were similar with teriparatide and risedronate.

    Outcome
    No significant changeAdverse events
    Study

    n = 92

    Comparator
    Risedronate
    Analysis
    Secondary
    Outcome group
    Adverse events · Whole body
    Studied dose
    20 μg/day · 18 monthsAs given in this study (human).

    Source sentences

    Summary
    Adverse events were similar between groups.
    2 context sentences
    Summary · context
    We performed a randomized, open-label trial in men who have taken glucocorticoids (GC) for ≥3 months, and had an areal bone mineral density (aBMD) T-score ≤ -1.5 standard deviations.
    Summary · context
    Subjects received 20 μg/d teriparatide (n = 45) or 35 mg/week risedronate (n = 47) for 18 months.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In men with glucocorticoid-induced osteoporosis, teriparatide increased trabecular BMD more than risedronate.

    In plain wordsIn men with glucocorticoid-induced osteoporosis, teriparatide increased trabecular bone density more than risedronate.

    Outcome
    IncreaseTrabecular BMD at 18 months
    Study

    n = 92

    Comparator
    Risedronate
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 μg/day · 18 monthsAs given in this study (human).

    Measurements

    BMD increase
    16.3%
    teriparatide
    BMD increase
    3.8%
    risedronate

    Source sentences

    Summary
    At 18 months, trabecular BMD had significantly increased for both treatments, with significantly greater increases with teriparatide (16.3% versus 3.8%; p = 0.004).
    2 context sentences
    Summary · context
    We performed a randomized, open-label trial in men who have taken glucocorticoids (GC) for ≥3 months, and had an areal bone mineral density (aBMD) T-score ≤ -1.5 standard deviations.
    Summary · context
    Subjects received 20 μg/d teriparatide (n = 45) or 35 mg/week risedronate (n = 47) for 18 months.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In men with glucocorticoid-induced osteoporosis, no new clinical fractures occurred with teriparatide, versus five (10.6%) with risedronate (p = 0.056).

    In plain wordsIn men with glucocorticoid-induced osteoporosis, no teriparatide patients had new clinical fractures, versus five with risedronate (p = 0.056).

    Outcome
    No significant changeNew clinical fractures
    Study

    n = 92

    Comparator
    Risedronate
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 μg/day · 18 monthsAs given in this study (human).

    Measurements

    New clinical fractures
    5 patients
    risedronate
    New clinical fractures
    10.6%
    risedronate

    Source sentences

    Summary
    None of the patients on teriparatide but five (10.6%) on risedronate developed new clinical fractures (p = 0.056).
    2 context sentences
    Summary · context
    We performed a randomized, open-label trial in men who have taken glucocorticoids (GC) for ≥3 months, and had an areal bone mineral density (aBMD) T-score ≤ -1.5 standard deviations.
    Summary · context
    Subjects received 20 μg/d teriparatide (n = 45) or 35 mg/week risedronate (n = 47) for 18 months.

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 3Results postedNCT00503399

Comparison of the Effects of 2 Drugs on Lumbar Spine Volumetric BMD in Men With Glucocorticoid-Induced Osteoporosis

Eli Lilly and Companyn = 92Jul 2007 to Oct 2010

Osteoporosis

Trial pageClinicalTrials.govUpdated 13 Mar 2012

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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