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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name EuroGIOPS

NCTNCT00503399 (opens ClinicalTrials.gov in a new tab)Other id11716Other idB3D-EW-GHDH
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
92 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Open label (no masking)
Countries
4 countries

Germany, Greece, Italy, Spain

Start
Jul 2007
Primary completion
Oct 2010
Completion
Oct 2010
First posted
18 Jul 2007 (estimated)
Last update posted
13 Mar 2012 (estimated)
Conditions
Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20072008200920102011
  1. Ph 3

    EuroGIOPS

    NCT00503399

    Jul 2007 to Oct 2010

Registry summary

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

The objective of this study is to test the hypothesis that teriparatide is superior to the active comparator in the change from baseline to 18 months of lumbar spine volumetric trabecular bone mineral density (BMD) in males with glucocorticoid-induced osteoporosis.

Interventions

  • TeriparatideDrug
  • RisedronateDrug

Arms2

  • Experimental

    Teriparatide

    Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD).

  • Active comparator

    Risedronate

    Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Tomography (QCT) at 18 Months

    Time frame · Baseline, 18 months

    Registry description

    Least Squares (LS) Means were adjusted for age, baseline serum aminoterminal propeptide of Type I procollagen (P1NP), fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.

Secondary outcomes(8)

  1. Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Technology (QCT) at 6 Months

    Time frame · Baseline, 6 months

    Registry description

    Least Squares (LS) Means were adjusted for age, baseline propeptide of Type I procollagen (P1NP), fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.

  2. Change From Baseline in High Resolution Quantitative Computerized Technology (HR-QCT) of Integral and Trabecular Bone Mineral Density (BMD) of the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months

    Time frame · Baseline, 6 months, 18 months

    Registry description

    Three-dimensional (3-D) microstructure variables of T12 were assessed by HR-QCT. In contrast with regular QCT that assessed 3 millimeter (mm) slide thickness, HR-QCT used segmentation of 1 single vertebra with approximately 100 consecutive slides reconstructed at 300-400 micrometer (µm) slice increments covering the complete vertebral body. Least Squares (LS) Means were adjusted for age, baseline P1NP, fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.

  3. Change From Baseline in Anterior Bending and Axial Torsion by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength

    Time frame · Baseline, 6 months, 18 months

    Registry description

    Anterior bending and axial torsion were measured using HR-QCT-based finite element analysis to determine stiffness and strength of T12. Stiffness evaluated strength of the vertebral body, defined as the slope of the initial step of the force-displacement curve. Strength of the vertebral body was evaluated under compressive loading conditions using computer simulation. LS Means were adjusted for age, baseline P1NP, fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.

  4. Change From Baseline in Axial Compression by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength

    Time frame · Baseline, 6 months, 18 months

    Registry description

    Axial compression was measured using HR-QCT-based finite element analysis to determine stiffness and strength of T12. Stiffness evaluated the strength of the vertebral body, defined as the slope of the initial step of the force-displacement curve. Strength of the vertebral body was evaluated under compressive loading conditions using computer simulation. LS Means were adjusted for age, baseline P1NP, fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.

  5. Change From Baseline in Areal Bone Mineral Density (BMD) at Lumbar Spine, Femoral Neck, and Total Hip at 18 Months

    Time frame · Baseline, 18 months

    Registry description

    Dual x-ray absorptiometry (DXA) techniques validated this measurement at skeletal sites that are at risk of osteoporotic fracture, such as lumbar spine, femoral neck, and hip.

  6. Change From Baseline in Serum Aminoterminal Propeptide of Type I Procollagen (P1NP) at 3 Months, 6 Months, and 18 Months

    Time frame · Baseline, 3 months, 6 months, 18 months

    Registry description

    P1NP was used as a serum biochemical marker of collagen synthesis, reflecting the formation of new osteoid.

  7. Change From Baseline in Serum Type I Collagen Degradation Fragments (β-CTx) at 3 Months, 6 Months, and 18 Months

    Time frame · 3, 6, 18 months

    Registry description

    β-CTx was used as a biochemical marker of bone turnover/resorption, reflecting collagen breakdown of the bone matrix.

  8. Number of Participants With Adverse Events (AEs)

    Time frame · Baseline up to 18 months

    Registry description

    Summary tables of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module. Fractures that occurred during the study were collected separately as an additional safety variable. The number of participants experiencing hypercalcemia was summarized for each treatment arm. Hypercalcemia was defined as a serum calcium level corrected for albumin of \>2.7 millimole per liter (mmol/L) (10.8 milligram per deciliter \[mg/dL\]).

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 outcomeLeast squares mean· Baseline, 18 months

Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Tomography (QCT) at 18 Months

GroupValue (milligram per cubic centimeter (mg/cm^3))Spread
Teriparatide12.283.16
Risedronate2.943.14
Secondary and other outcome results(7)
Secondary outcomeLeast squares mean· Baseline, 6 months

Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Technology (QCT) at 6 Months

GroupValue (milligram per cubic centimeter (mg/cm^3))Spread
Teriparatide4.313.15
Risedronate2.523.16
Secondary outcomeLeast squares mean· Baseline, 6 months, 18 months

Change From Baseline in High Resolution Quantitative Computerized Technology (HR-QCT) of Integral and Trabecular Bone Mineral Density (BMD) of the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months

GroupValue (milligram per cubic centimeter (mg/cm^3))Spread
Teriparatide-0.426.42
Risedronate-1.917.11
Secondary outcomeLeast squares mean· Baseline, 6 months, 18 months

Change From Baseline in Anterior Bending and Axial Torsion by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength

GroupValue (Newton/millimeter/radian (N/mm/rad))Spread
Teriparatide664969.0317684.0
Risedronate415705.0323135.0
Secondary outcomeLeast squares mean· Baseline, 6 months, 18 months

Change From Baseline in Axial Compression by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength

GroupValue (Newton per millimeter (N/mm))Spread
Teriparatide890.7596.6
Risedronate407.6607.6
Secondary outcomeMean· Baseline, 18 months

Change From Baseline in Areal Bone Mineral Density (BMD) at Lumbar Spine, Femoral Neck, and Total Hip at 18 Months

GroupValue (grams per square centimeter (g/cm^2))Spread
Teriparatide0.0680.0685
Risedronate0.0370.0493
Secondary outcomeLeast squares mean· Baseline, 3 months, 6 months, 18 months

Change From Baseline in Serum Aminoterminal Propeptide of Type I Procollagen (P1NP) at 3 Months, 6 Months, and 18 Months

GroupValue (micrograms per deciliter (μg/dL))Spread
Teriparatide27.338.32
Risedronate-16.097.82
Secondary outcomeLeast squares mean· 3, 6, 18 months

Change From Baseline in Serum Type I Collagen Degradation Fragments (β-CTx) at 3 Months, 6 Months, and 18 Months

GroupValue (nanograms per deciliter (ng/dL))Spread
Teriparatide0.120.07
Risedronate-0.150.07

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
TeriparatideTeriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)–13 / 4522 / 45
RisedronateRisedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)–22 / 4730 / 47

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2013

7 results

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

Glüer et al. 2013Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Researchcited by 108

PMID 23322362PMC3708101DOI 10.1002/jbmr.1870PUB-23322362

CC BY7 results
Download PDFSee results (7)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedGraeff C, Marin F, Petto H, Kayser O, Reisinger A, Pena J, Zysset P, Gluer CC. High resolution quantitative computed tomography-based assessment of trabecular microstructure and strength estimates by finite-element analysis of the spine, but not DXA, reflects vertebral fracture status in men with glucocorticoid-induced osteoporosis. Bone. 2013 Feb;52(2):568-77. doi: 10.1016/j.bone.2012.10.036. Epub 2012 Nov 10. PMID 23149277

Eligibility

Who could join, as posted.

Sex
Male
Age
from 25 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Ambulatory men 25 years of age and older presenting to Visit 1 with a bone mineral density (BMD) of at least 1.5 standard deviation (SD) below the corresponding normal young adult men average BMD (T score of -1.5 or lower), as determined from the manufacturer's database at any of the following regions of interest: total hip, femoral neck, or lumbar spine * Have received glucocorticoid therapy at an average dose of at least 5.0 milligrams (mg) per day of prednisone or its equivalent for a minimum of 3 consecutive months immediately preceding screening (Visit 1), as determined by medical history. * A minimum of 2 lumbar vertebrae (L) in the L-1 through L-3 region must be evaluable by quantitative computerized tomography. * Normal or clinically insignificant abnormal laboratory values (as determined by the investigator) including serum calcium, parathyroid hormone (PTH) (1 84), and 25 hydroxyvitamin D concentrations, and alkaline phosphatase activity. Exclusion Criteria: * Presence of a mild, moderate, or severe spinal fracture in both the twelfth thoracic vertebra (T-12) and first lumbar vertebra (L-1), as determined by the central reading facility using the semiquantitative technique. * Abnormal albumin-corrected serum calcium levels * History of unresolved skeletal diseases that affect bone metabolism other than glucocorticoid-induced osteoporosis * History of malignant neoplasms in the 5 years prior to Visit 2, with the exception of superficial basal cell or squamous cell carcinomas of the skin that have been definitively treated. Increased baseline risk of osteosarcoma; this includes patients with Paget's disease of the bone, previous primary skeletal malignancy, or skeletal exposure to therapeutic irradiation. * Abnormal thyroid function not corrected by therapy * Past and/or current treatment with certain medications.

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