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Trial record 34 of 101 for:    Risedronate

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

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ClinicalTrials.gov Identifier: NCT00503399
Recruitment Status : Completed
First Posted : July 18, 2007
Results First Posted : November 8, 2011
Last Update Posted : March 13, 2012
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Osteoporosis
Interventions Drug: Teriparatide
Drug: Risedronate
Enrollment 92
Recruitment Details  
Pre-assignment Details Of the 174 participants who were enrolled into the study, 92 were eligible and randomly assigned to the treatment arms.
Arm/Group Title Teriparatide Risedronate
Hide Arm/Group Description Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD) Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
Period Title: Overall Study
Started 45 47
Completed 38 39
Not Completed 7 8
Reason Not Completed
Death             2             1
Protocol Violation             1             0
Withdrawal by Subject             4             2
Adverse Event             0             3
Lost to Follow-up             0             2
Arm/Group Title Teriparatide Risedronate Total
Hide Arm/Group Description Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD) Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW) Total of all reporting groups
Overall Number of Baseline Participants 45 47 92
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 47 participants 92 participants
57.5  (12.80) 55.1  (15.54) 56.3  (14.24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 47 participants 92 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
45
 100.0%
47
 100.0%
92
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants 47 participants 92 participants
Caucasian 44 46 90
Hispanic 0 1 1
East Asian 1 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants 47 participants 92 participants
Germany 19 21 40
Greece 6 6 12
Italy 5 8 13
Spain 15 12 27
Number of participants with fractures before study  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants 47 participants 92 participants
With fractures 19 17 36
Without fractures 26 30 56
1.Primary Outcome
Title Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Tomography (QCT) at 18 Months
Hide 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.
Time Frame Baseline, 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the primary efficacy population, which included all randomized participants who received at least 1 dose of study medication (full analysis set) and had a lumbar spine volumetric trabecular BMD measurement at baseline and at ≥1 post-baseline visit.
Arm/Group Title Teriparatide Risedronate
Hide Arm/Group Description:
Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
Overall Number of Participants Analyzed 39 40
Least Squares Mean (Standard Error)
Unit of Measure: milligram per cubic centimeter (mg/cm^3)
12.28  (3.16) 2.94  (3.14)
2.Secondary Outcome
Title Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Technology (QCT) at 6 Months
Hide 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.
Time Frame Baseline, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the primary efficacy population, which included all randomized participants who received at least 1 dose of study medication (full analysis set) and had a lumbar spine volumetric trabecular BMD measurement at baseline and at ≥1 post-baseline visit.
Arm/Group Title Teriparatide Risedronate
Hide Arm/Group Description:
Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
Overall Number of Participants Analyzed 39 40
Least Squares Mean (Standard Error)
Unit of Measure: milligram per cubic centimeter (mg/cm^3)
4.31  (3.15) 2.52  (3.16)
3.Secondary Outcome
Title 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
Hide 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.
Time Frame Baseline, 6 months, 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.
Arm/Group Title Teriparatide Risedronate
Hide Arm/Group Description:
Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
Overall Number of Participants Analyzed 39 40
Least Squares Mean (Standard Error)
Unit of Measure: milligram per cubic centimeter (mg/cm^3)
Integral BMD at 6 months -0.42  (6.42) -1.91  (7.11)
Integral BMD at 18 months 10.72  (6.22) 0.68  (7.08)
Trabecular BMD at 6 months -0.70  (5.26) -0.87  (5.85)
Trabecular BMD at 18 months 9.53  (5.09) 0.22  (5.82)
4.Secondary Outcome
Title 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
Hide 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.
Time Frame Baseline, 6 months, 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.
Arm/Group Title Teriparatide Risedronate
Hide Arm/Group Description:
Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
Overall Number of Participants Analyzed 39 40
Least Squares Mean (Standard Error)
Unit of Measure: Newton/millimeter/radian (N/mm/rad)
Anterior bending stiffness at 6 months 664969.0  (317684.0) 415705.0  (323135.0)
Anterior bending stiffness at 18 months 1209225.0  (300977.0) 233283.0  (322829.0)
Axial torsion stiffness at 6 months 142902.9  (71714.2) 77830.7  (72947.9)
Axial torsion stiffness at 18 months 279392.8  (68284.5) 56639.3  (72946.9)
Anterior bending strength at 6 months 12490.9  (8405.0) 8827.2  (8741.0)
Anterior bending strength at 18 months 26046.4  (8304.1) 4822.0  (8686.6)
Axial torsion strength at 6 months 6127.7  (4132.3) 3664.0  (4233.5)
Axial torsion strength at 18 months 14181.3  (3954.4) 2545.8  (4228.7)
5.Secondary Outcome
Title 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
Hide 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.
Time Frame Baseline, 6 months, 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.
Arm/Group Title Teriparatide Risedronate
Hide Arm/Group Description:
Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
Overall Number of Participants Analyzed 39 40
Least Squares Mean (Standard Error)
Unit of Measure: Newton per millimeter (N/mm)
Axial compression stiffness at 6 months 890.7  (596.6) 407.6  (607.6)
Axial compression stiffness at 18 months 1973.9  (569.0) 363.7  (605.9)
Axial compression strength at 6 months 580.7  (444.6) 313.6  (457.0)
Axial compression strength at 18 months 1287.5  (424.0) 209.4  (455.5)
6.Secondary Outcome
Title Change From Baseline in Areal Bone Mineral Density (BMD) at Lumbar Spine, Femoral Neck, and Total Hip at 18 Months
Hide 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.
Time Frame Baseline, 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.
Arm/Group Title Teriparatide Risedronate
Hide Arm/Group Description:
Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
Overall Number of Participants Analyzed 45 47
Mean (Standard Deviation)
Unit of Measure: grams per square centimeter (g/cm^2)
Lumbar spine (n=38; n=39) 0.068  (0.0685) 0.037  (0.0493)
Hip (n=38; n=37) 0.014  (0.0319) 0.007  (0.0320)
Femoral neck (n=38; n=37) 0.014  (0.0446) -0.007  (0.0333)
7.Secondary Outcome
Title Change From Baseline in Serum Aminoterminal Propeptide of Type I Procollagen (P1NP) at 3 Months, 6 Months, and 18 Months
Hide Description P1NP was used as a serum biochemical marker of collagen synthesis, reflecting the formation of new osteoid.
Time Frame Baseline, 3 months, 6 months, 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.
Arm/Group Title Teriparatide Risedronate
Hide Arm/Group Description:
Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
Overall Number of Participants Analyzed 45 47
Least Squares Mean (Standard Error)
Unit of Measure: micrograms per deciliter (μg/dL)
P1NP at 3 months 27.33  (8.32) -16.09  (7.82)
P1NP at 6 months 52.55  (8.27) -16.50  (7.95)
P1NP at 18 months 28.48  (8.74) -15.58  (8.58)
8.Secondary Outcome
Title Change From Baseline in Serum Type I Collagen Degradation Fragments (β-CTx) at 3 Months, 6 Months, and 18 Months
Hide Description β-CTx was used as a biochemical marker of bone turnover/resorption, reflecting collagen breakdown of the bone matrix.
Time Frame 3, 6, 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.
Arm/Group Title Teriparatide Risedronate
Hide Arm/Group Description:
Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
Overall Number of Participants Analyzed 45 47
Least Squares Mean (Standard Error)
Unit of Measure: nanograms per deciliter (ng/dL)
β-CTx at 3 months 0.12  (0.07) -0.15  (0.07)
β-CTx at 6 months 0.25  (0.07) -0.14  (0.07)
β-CTx at 18 months 0.03  (0.08) -0.11  (0.07)
9.Secondary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide 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]).
Time Frame Baseline up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all participants who received study treatment.
Arm/Group Title Teriparatide Risedronate
Hide Arm/Group Description:
Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
Overall Number of Participants Analyzed 45 47
Measure Type: Number
Unit of Measure: participants
Serious Adverse Events (SAEs) 13 22
Other Non-serious AEs 22 30
Fractures 0 5
Hypercalcemia 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Teriparatide Risedronate
Hide Arm/Group Description Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD) Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
All-Cause Mortality
Teriparatide Risedronate
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Teriparatide Risedronate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/45 (28.89%)      22/47 (46.81%)    
Blood and lymphatic system disorders     
Anaemia  1  1/45 (2.22%)  1 0/47 (0.00%)  0
Cardiac disorders     
Angina pectoris  1  0/45 (0.00%)  0 1/47 (2.13%)  1
Aortic valve incompetence  1  1/45 (2.22%)  1 0/47 (0.00%)  0
Atrial fibrillation  1  0/45 (0.00%)  0 1/47 (2.13%)  1
Cardiac failure  1  0/45 (0.00%)  0 1/47 (2.13%)  1
Ear and labyrinth disorders     
Sudden hearing loss  1  0/45 (0.00%)  0 1/47 (2.13%)  1
Eye disorders     
Cataract  1  1/45 (2.22%)  1 0/47 (0.00%)  0
Gastrointestinal disorders     
Anal fistula  1  0/45 (0.00%)  0 1/47 (2.13%)  2
Crohn's disease  1  0/45 (0.00%)  0 2/47 (4.26%)  2
Gastrointestinal haemorrhage  1  1/45 (2.22%)  1 0/47 (0.00%)  0
Pancreatitis acute  1  0/45 (0.00%)  0 1/47 (2.13%)  1
General disorders     
Chest pain  1  0/45 (0.00%)  0 1/47 (2.13%)  1
Sudden death  1  1/45 (2.22%)  1 0/47 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis  1  0/45 (0.00%)  0 1/47 (2.13%)  1
Infections and infestations     
Anal abscess  1  0/45 (0.00%)  0 1/47 (2.13%)  1
Cytomegalovirus infection  1  1/45 (2.22%)  1 0/47 (0.00%)  0
Intervertebral discitis  1  0/45 (0.00%)  0 1/47 (2.13%)  1
Postoperative abscess  1  0/45 (0.00%)  0 1/47 (2.13%)  1
Injury, poisoning and procedural complications     
Ankle fracture  1  0/45 (0.00%)  0 1/47 (2.13%)  1
Fall  1  0/45 (0.00%)  0 2/47 (4.26%)  2
Femoral neck fracture  1  0/45 (0.00%)  0 1/47 (2.13%)  1
Head injury  1  0/45 (0.00%)  0 1/47 (2.13%)  1
Procedural pain  1  1/45 (2.22%)  1 0/47 (0.00%)  0
Radius fracture  1  0/45 (0.00%)  0 1/47 (2.13%)  1
Rib fracture  1  0/45 (0.00%)  0 1/47 (2.13%)  4
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion  1  3/45 (6.67%)  3 0/47 (0.00%)  0
Osteoarthritis  1  1/45 (2.22%)  1 0/47 (0.00%)  0
Rheumatoid arthritis  1  0/45 (0.00%)  0 1/47 (2.13%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Intestinal adenocarcinoma  1  0/45 (0.00%)  0 1/47 (2.13%)  1
Prostatic adenoma  1  0/45 (0.00%)  0 1/47 (2.13%)  1
Seminoma  1  0/45 (0.00%)  0 1/47 (2.13%)  1
Nervous system disorders     
Cognitive disorder  1  0/45 (0.00%)  0 1/47 (2.13%)  1
Renal and urinary disorders     
Nephrolithiasis  1  0/45 (0.00%)  0 1/47 (2.13%)  1
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  1/45 (2.22%)  1 0/47 (0.00%)  0
Asthma  1  0/45 (0.00%)  0 1/47 (2.13%)  1
Chronic obstructive pulmonary disease  1  2/45 (4.44%)  2 3/47 (6.38%)  3
Dyspnoea  1  1/45 (2.22%)  1 0/47 (0.00%)  0
Epistaxis  1  0/45 (0.00%)  0 1/47 (2.13%)  1
Skin and subcutaneous tissue disorders     
Leukoplakia  1  1/45 (2.22%)  1 0/47 (0.00%)  0
Scar  1  0/45 (0.00%)  0 1/47 (2.13%)  1
Skin ulcer  1  0/45 (0.00%)  0 1/47 (2.13%)  1
Vascular disorders     
Femoral artery occlusion  1  0/45 (0.00%)  0 1/47 (2.13%)  1
Hypertensive crisis  1  0/45 (0.00%)  0 2/47 (4.26%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Teriparatide Risedronate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/45 (48.89%)      30/47 (63.83%)    
Gastrointestinal disorders     
Abdominal pain upper  1  0/45 (0.00%)  0 2/47 (4.26%)  2
Constipation  1  1/45 (2.22%)  1 2/47 (4.26%)  2
Nausea  1  1/45 (2.22%)  1 3/47 (6.38%)  3
Reflux oesophagitis  1  1/45 (2.22%)  1 2/47 (4.26%)  2
General disorders     
Oedema peripheral  1  3/45 (6.67%)  4 2/47 (4.26%)  2
Hepatobiliary disorders     
Cholelithiasis  1  2/45 (4.44%)  2 0/47 (0.00%)  0
Infections and infestations     
Influenza  1  4/45 (8.89%)  4 3/47 (6.38%)  4
Lung infection  1  0/45 (0.00%)  0 2/47 (4.26%)  2
Nasopharyngitis  1  2/45 (4.44%)  2 2/47 (4.26%)  2
Injury, poisoning and procedural complications     
Rib fracture  1  0/45 (0.00%)  0 2/47 (4.26%)  4
Investigations     
Blood cholesterol increased  1  0/45 (0.00%)  0 2/47 (4.26%)  2
Weight decreased  1  0/45 (0.00%)  0 2/47 (4.26%)  2
Weight increased  1  1/45 (2.22%)  1 3/47 (6.38%)  3
Metabolism and nutrition disorders     
Obesity  1  2/45 (4.44%)  2 0/47 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  4/45 (8.89%)  4 3/47 (6.38%)  4
Back pain  1  3/45 (6.67%)  3 0/47 (0.00%)  0
Pain in extremity  1  1/45 (2.22%)  1 2/47 (4.26%)  2
Nervous system disorders     
Headache  1  1/45 (2.22%)  1 2/47 (4.26%)  3
Paraesthesia  1  2/45 (4.44%)  2 0/47 (0.00%)  0
Psychiatric disorders     
Insomnia  1  2/45 (4.44%)  2 0/47 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  0/45 (0.00%)  0 3/47 (6.38%)  3
Skin and subcutaneous tissue disorders     
Erythema  1  2/45 (4.44%)  2 0/47 (0.00%)  0
Urticaria  1  0/45 (0.00%)  0 2/47 (4.26%)  2
Surgical and medical procedures     
Cataract operation  1  2/45 (4.44%)  2 1/47 (2.13%)  2
Vascular disorders     
Haematoma  1  0/45 (0.00%)  0 2/47 (4.26%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA (12.0)
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.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00503399     History of Changes
Other Study ID Numbers: 11716
B3D-EW-GHDH ( Other Identifier: Eli Lilly and Company )
First Submitted: July 16, 2007
First Posted: July 18, 2007
Results First Submitted: October 4, 2011
Results First Posted: November 8, 2011
Last Update Posted: March 13, 2012