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| ID | Type | Description | Link |
|---|---|---|---|
| B3D-EW-GHDH | Other Identifier | Eli Lilly and Company |
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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.
This study is a multinational, European, multicenter, randomized, open-label, active comparator controlled study with 2 study periods: a screening phase of up to 6 weeks, and an open-label treatment phase of 18 months. Approximately 100 adult men with osteoporosis associated with sustained glucocorticoid therapy will be enrolled into the study. Approximately one-half of the participants (at all investigational sites) will be randomized to teriparatide 20 micrograms/day (ug/day given as a subcutaneous (sc) injection), and the other half randomized to risedronate 35 milligrams (mg) once weekly (QW) oral (po) tablet. All participants will receive approximately 1000 mg/day elemental calcium and 800 to 1200 international units per day (IU/day) of vitamin D.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teriparatide | Experimental | Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD). |
|
| Risedronate | Active Comparator | Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teriparatide | Drug | 20 µg/day sc for 18 months |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Tomography (QCT) at 18 Months | 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. | Baseline, 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Technology (QCT) at 6 Months | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bad Nauheim | 61231 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23322362 | Derived | Gluer CC, Marin F, Ringe JD, Hawkins F, Moricke R, Papaioannu N, Farahmand P, Minisola S, Martinez G, Nolla JM, Niedhart C, Guanabens N, Nuti R, Martin-Mola E, Thomasius F, Kapetanos G, Pena J, Graeff C, Petto H, Sanz B, Reisinger A, Zysset PK. Comparative effects of teriparatide and risedronate in glucocorticoid-induced osteoporosis in men: 18-month results of the EuroGIOPs trial. J Bone Miner Res. 2013 Jun;28(6):1355-68. doi: 10.1002/jbmr.1870. | |
| 23149277 |
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Of the 174 participants who were enrolled into the study, 92 were eligible and randomly assigned to the treatment arms.
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| ID | Title | Description |
|---|---|---|
| FG000 | Teriparatide | Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD) |
| FG001 | Risedronate | Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Risedronate | Drug | 35 mg/week po for 18 months |
|
|
| Baseline, 6 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 | 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. | 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 | 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. | 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 | 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. | Baseline, 6 months, 18 months |
| Change From Baseline in Areal Bone Mineral Density (BMD) at Lumbar Spine, Femoral Neck, and Total Hip at 18 Months | 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. | Baseline, 18 months |
| Change From Baseline in Serum Aminoterminal Propeptide of Type I Procollagen (P1NP) at 3 Months, 6 Months, and 18 Months | P1NP was used as a serum biochemical marker of collagen synthesis, reflecting the formation of new osteoid. | Baseline, 3 months, 6 months, 18 months |
| Change From Baseline in Serum Type I Collagen Degradation Fragments (β-CTx) at 3 Months, 6 Months, and 18 Months | β-CTx was used as a biochemical marker of bone turnover/resorption, reflecting collagen breakdown of the bone matrix. | 3, 6, 18 months |
| Number of Participants With Adverse Events (AEs) | 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]). | Baseline up to 18 months |
| Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Frankfurt | 60528 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hamburg | 22415 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Heinsberg | 52525 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Leverkusen | 51375 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Magdeburg | 39110 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Potsdam | 14469 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kifissia | 14561 | Greece |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Thessaloniki | 56429 | Greece |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Rome | 00161 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Siena | 53100 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Barcelona | 08907 | Spain |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Madrid | 28046 | Spain |
| Derived |
| Graeff 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Teriparatide | Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD) |
| BG001 | Risedronate | Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Number of participants with fractures before study | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Tomography (QCT) at 18 Months | 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. | 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. | Posted | Least Squares Mean | Standard Error | milligram per cubic centimeter (mg/cm^3) | Baseline, 18 months |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Technology (QCT) at 6 Months | 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. | 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. | Posted | Least Squares Mean | Standard Error | milligram per cubic centimeter (mg/cm^3) | Baseline, 6 months |
|
| |||||||||||||||||||||||||||||
| 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 | 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. | The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication. | Posted | Least Squares Mean | Standard Error | milligram per cubic centimeter (mg/cm^3) | Baseline, 6 months, 18 months |
| ||||||||||||||||||||||||||||||
| 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 | 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. | The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication. | Posted | Least Squares Mean | Standard Error | Newton/millimeter/radian (N/mm/rad) | Baseline, 6 months, 18 months |
| ||||||||||||||||||||||||||||||
| 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 | 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. | The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication. | Posted | Least Squares Mean | Standard Error | Newton per millimeter (N/mm) | Baseline, 6 months, 18 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Areal Bone Mineral Density (BMD) at Lumbar Spine, Femoral Neck, and Total Hip at 18 Months | 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. | The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | grams per square centimeter (g/cm^2) | Baseline, 18 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Serum Aminoterminal Propeptide of Type I Procollagen (P1NP) at 3 Months, 6 Months, and 18 Months | P1NP was used as a serum biochemical marker of collagen synthesis, reflecting the formation of new osteoid. | The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication. | Posted | Least Squares Mean | Standard Error | micrograms per deciliter (μg/dL) | Baseline, 3 months, 6 months, 18 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Serum Type I Collagen Degradation Fragments (β-CTx) at 3 Months, 6 Months, and 18 Months | β-CTx was used as a biochemical marker of bone turnover/resorption, reflecting collagen breakdown of the bone matrix. | The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication. | Posted | Least Squares Mean | Standard Error | nanograms per deciliter (ng/dL) | 3, 6, 18 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) | 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]). | The safety analysis set included all participants who received study treatment. | Posted | Number | participants | Baseline up to 18 months |
|
|
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Teriparatide | Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD) | 13 | 45 | 22 | 45 | ||
| EG001 | Risedronate | Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW) | 22 | 47 | 30 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Aortic valve incompetence | Cardiac disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Sudden hearing loss | Ear and labyrinth disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Cataract | Eye disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Sudden death | General disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MEDDRA (12.0) | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MEDDRA (12.0) | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MEDDRA (12.0) | Systematic Assessment |
| |
| Postoperative abscess | Infections and infestations | MEDDRA (12.0) | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MEDDRA (12.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MEDDRA (12.0) | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MEDDRA (12.0) | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MEDDRA (12.0) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MEDDRA (12.0) | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MEDDRA (12.0) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MEDDRA (12.0) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Intestinal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA (12.0) | Systematic Assessment |
| |
| Prostatic adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA (12.0) | Systematic Assessment |
| |
| Seminoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA (12.0) | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Leukoplakia | Skin and subcutaneous tissue disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Scar | Skin and subcutaneous tissue disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Femoral artery occlusion | Vascular disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MEDDRA (12.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Reflux oesophagitis | Gastrointestinal disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MEDDRA (12.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MEDDRA (12.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MEDDRA (12.0) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MEDDRA (12.0) | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MEDDRA (12.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MEDDRA (12.0) | Systematic Assessment |
| |
| Weight increased | Investigations | MEDDRA (12.0) | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MEDDRA (12.0) | Systematic Assessment |
| |
| Cataract operation | Surgical and medical procedures | MEDDRA (12.0) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MEDDRA (12.0) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019379 | Teriparatide |
| D000068296 | Risedronic Acid |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
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| Hispanic |
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| East Asian |
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| Greece |
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| Italy |
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| Spain |
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| Without fractures |
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