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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00503399
First received: July 16, 2007
Last updated: March 12, 2012
Last verified: October 2011
Results First Received: October 4, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Osteoporosis
Interventions: Drug: Teriparatide
Drug: Risedronate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 174 participants who were enrolled into the study, 92 were eligible and randomly assigned to the treatment arms.

Reporting Groups
  Description
Teriparatide Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
Risedronate Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)

Participant Flow:   Overall Study
    Teriparatide     Risedronate  
STARTED     45     47  
COMPLETED     38     39  
NOT COMPLETED     7     8  
Death                 2                 1  
Protocol Violation                 1                 0  
Withdrawal by Subject                 4                 2  
Adverse Event                 0                 3  
Lost to Follow-up                 0                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Teriparatide Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
Risedronate Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
Total Total of all reporting groups

Baseline Measures
    Teriparatide     Risedronate     Total  
Number of Participants  
[units: participants]
  45     47     92  
Age  
[units: years]
Mean ± Standard Deviation
  57.5  ± 12.80     55.1  ± 15.54     56.3  ± 14.24  
Gender  
[units: participants]
     
Female     0     0     0  
Male     45     47     92  
Race/Ethnicity, Customized  
[units: participants]
     
Caucasian     44     46     90  
Hispanic     0     1     1  
East Asian     1     0     1  
Region of Enrollment  
[units: participants]
     
Germany     19     21     40  
Greece     6     6     12  
Italy     5     8     13  
Spain     15     12     27  
Number of participants with fractures before study  
[units: participants]
     
With fractures     19     17     36  
Without fractures     26     30     56  



  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   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 ]

3.  Secondary:   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 ]

4.  Secondary:   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 ]

5.  Secondary:   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 ]

6.  Secondary:   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 ]

7.  Secondary:   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 ]

8.  Secondary:   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 ]

9.  Secondary:   Number of Participants With Adverse Events (AEs)   [ Time Frame: Baseline up to 18 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


No publications provided by Eli Lilly and Company

Publications automatically indexed to this study:

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00503399     History of Changes
Other Study ID Numbers: 11716, B3D-EW-GHDH
Study First Received: July 16, 2007
Results First Received: October 4, 2011
Last Updated: March 12, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Italy: Ethics Committee
Spain: Spanish Agency of Medicines