Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG052123-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Aging (NIA) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this research study is to find out if denosumab (Prolia®), an injection given in the arm under the skin every 6 months, works to treat bone loss and prevent it from worsening in older men and women (ages 65 and older) who have osteoporosis and reside in long-term care (LTC) facilities.
Objective:
The long term goal is to improve health, well-being and quality of life in the frail long-term care (LTC) elderly population by reducing fractures. The short term goal is to demonstrate efficacy of the non-bisphosphonate denosumab to improve bone mineral density (BMD), a necessary (but not sufficient) pre-condition of a large fracture reduction trial. The investigators propose to conduct a 2-year, randomized, double-blind, calcium-vitamin D controlled trial to test the efficacy and predictability of the antiresorptive RANK ligand inhibitor, denosumab (60 mg), among a cohort of 212 institutionalized, under-served, frail men and women ≥65 years old in LTC.
Specific Aims:
Aim 1: To evaluate efficacy of denosumab in improving/maintaining bone mineral density. The investigators will measure conventional hip and spine bone mineral density (BMD).
Primary Hypothesis: After 2 years, women and men on denosumab will have greater hip and spine BMD increases.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women Denosumab | Experimental | Semi-annual dose for women: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements). |
|
| Women Placebo Group | Placebo Comparator | Semi-annual for women: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements). |
|
| Men Denosumab | Experimental | Semi-annual dose for men: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements). |
|
| Men Placebo Group | Placebo Comparator | Semi-annual for men: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| denosumab | Drug | Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone Density of the Total Hip | Bone Mineral Density (BMD) of the total hip percent change over 24 months as assessed by dual-energy x-ray absorptiometry (DXA) | 24 months |
| Bone Density of the Spine | Bone Mineral Density (BMD) of the spine percent change over 24 months as assessed by dual-energy x-ray absorptiometry (DXA) | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Distal Radius BMD | Percent change over 24 months | 24 Months |
| Femoral Neck BMD | Percent change over 24 months | 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| CTX | Bone Turnover Marker change from Baseline | 12 Months |
| P1NP | Bone Turnover Marker Change from Baseline | 12 Months |
Inclusion Criteria:
Ambulatory male and female residents with osteoporosis or low bone mass (at risk for fracture) ages 65 and older will be considered if:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Susan L Greenspan, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Senior Communities | Pittsburgh | Pennsylvania | 15213 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Women Denosumab | Semi-annual dose for women: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements). denosumab: Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement) Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement) |
| FG001 | Women Placebo Group | Semi-annual for Women: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements). Placebo: Semi-annual saline injection Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement) |
| FG002 | Men Denosumab | Semi-annual dose for men: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements). denosumab: Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement) Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement) |
| FG003 | Men Placebo Group | Semi-annual for men: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements). Placebo: Semi-annual saline injection Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Women Denosumab | Semi-annual dose for women: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements). denosumab: Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement) Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Bone Density of the Total Hip | Bone Mineral Density (BMD) of the total hip percent change over 24 months as assessed by dual-energy x-ray absorptiometry (DXA) | Posted | Mean | Standard Error | Percent change | 24 months |
|
24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Women Denosumab | Semi-annual dose for women: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements). denosumab: Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement) Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susan Greenspan | University of Pittsburgh | +14126922477 | greenspn@pitt.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 21, 2024 | Aug 22, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| D010024 | Osteoporosis |
| D058866 | Osteoporotic Fractures |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069448 | Denosumab |
| D002118 | Calcium |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | Semi-annual saline injection |
|
| Calcium and Vitamin D | Dietary Supplement | Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement) |
|
| TBS | Trabecular Bone Score (TBS) Percent change over 24 months. This not a scale. Higher values are better. | 24 Months |
| BG001 | Women Placebo Group | Semi-annual for women: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements). Placebo: Semi-annual saline injection Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement) |
| BG002 | Men Denosumab | Semi-annual dose for men: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements). denosumab: Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement) Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement) |
| BG003 | Men Placebo Group | Semi-annual for men: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements). Placebo: Semi-annual saline injection Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement) |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Bone Density of the Hip | Mean | Standard Deviation | g/cm^2 |
|
| Bone Density of Spine | Mean | Standard Deviation | g/cm^2 |
|
Semi-annual for Women: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements).
Placebo: Semi-annual saline injection
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
| OG002 | Men Denosumab | Semi-annual dose for women: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements). denosumab: Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement) Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement) |
| OG003 | Men Placebo Group | Semi-annual for Women: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements). Placebo: Semi-annual saline injection Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement) |
|
|
|
| Primary | Bone Density of the Spine | Bone Mineral Density (BMD) of the spine percent change over 24 months as assessed by dual-energy x-ray absorptiometry (DXA) | Posted | Mean | Standard Error | Percent change | 24 months |
|
|
|
|
| Secondary | Distal Radius BMD | Percent change over 24 months | Posted | Mean | Standard Deviation | Percent change from baseline | 24 Months |
|
|
|
|
| Secondary | Femoral Neck BMD | Percent change over 24 months | Posted | Mean | Standard Deviation | Percent change from baseline | 24 Months |
|
|
|
|
| Secondary | TBS | Trabecular Bone Score (TBS) Percent change over 24 months. This not a scale. Higher values are better. | Posted | Mean | Standard Deviation | Percent change from baseline | 24 Months |
|
|
|
|
| Other Pre-specified | CTX | Bone Turnover Marker change from Baseline | Posted | Mean | Standard Deviation | nmol/L | 12 Months |
|
|
|
|
| Other Pre-specified | P1NP | Bone Turnover Marker Change from Baseline | Posted | Mean | Standard Deviation | ug/L | 12 Months |
|
|
|
|
| 1 |
| 62 |
| 21 |
| 62 |
| 46 |
| 62 |
| EG001 | Women Placebo Group | Semi-annual for Women: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements). Placebo: Semi-annual saline injection Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement) | 4 | 61 | 26 | 61 | 50 | 61 |
| EG002 | Men Denosumab | Semi-annual dose for women: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements). denosumab: Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement) Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement) | 4 | 40 | 21 | 40 | 32 | 40 |
| EG003 | Men Placebo Group | Semi-annual for Women: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements). Placebo: Semi-annual saline injection Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement) | 2 | 38 | 15 | 38 | 33 | 38 |
| Atrial Fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Chest Pain | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Myocardial Ischaemia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA | Systematic Assessment |
|
| Dry Eye | Eye disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Faecaloma | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Rectal hemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Small bowel obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA | Systematic Assessment |
|
| Complication associated with device | General disorders | MedDRA | Systematic Assessment |
|
| Death | General disorders | MedDRA | Systematic Assessment |
|
| Incarcerated hernia | General disorders | MedDRA | Systematic Assessment |
|
| Pain | General disorders | MedDRA | Systematic Assessment |
|
| Bacteremia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Clostridium difficile infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Diabetes | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Ankle fracture | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Femur Fracture | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Hip fracture | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Inflammatory polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Lumbar vertebral fracture | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Rib fracture | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Adenosquamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Adenosquamous cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| B-cell small lymphocytic lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Endometrial Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Renal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Confusional state | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Internal capsule infarction | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Ischemic cerebral infarction | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Lacunar stroke | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Normal Pressure Hydrocephalus | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Transient ischemic attack | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Device malfunction | Product Issues | MedDRA | Systematic Assessment |
|
| Adjustment disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Suicidal Ideation | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Genitourinary tract infection | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Urosepsis | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Adenoviral upper respiratory infection | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Lobar Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Cellulitis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Aortic valve replacement | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Brachytherapy to prostate | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Cholecystectomy | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Hip arthroplasty | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Hysterosalpingo-oophorectomy | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Transurethral prostatectomy | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Embolic stroke | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Pulmonary embolism | Vascular disorders | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Pain | General disorders | MedDRA | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Benign neoplasm of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Confusional State | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Adenoviral Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Cellulitis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Skin Infection | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
Not provided
Not provided
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Using multiple imputation for missing data |
| .002 |
| Mean Difference (Final Values) |
| 5.16 |
| Standard Error of the Mean |
| 1.45 |
| 2-Sided |
| Superiority |
Using multiple imputation for missing data |
| .055 |
| Mean Difference (Final Values) |
| 2.45 |
| Standard Error of the Mean |
| 1.22 |
| 2-Sided |
| Superiority |
Using multiple imputation for missing data |
| .070 |
| Mean Difference (Final Values) |
| 2.46 |
| Standard Error of the Mean |
| 1.34 |
| 2-Sided |
| Superiority |
Using multiple imputation for missing data |
| .616 |
| Mean Difference (Final Values) |
| -1.17 |
| Standard Error of the Mean |
| 2.29 |
| 2-Sided |
| Superiority |
Using multiple imputation for missing data |
| .005 |
| Mean Difference (Final Values) |
| -.09 |
| Standard Error of the Mean |
| .03 |
| 2-Sided |
| Superiority |
Using multiple imputation for missing data |
| .038 |
| Mean Difference (Final Values) |
| -8.2 |
| Standard Error of the Mean |
| 3.9 |
| 2-Sided |
| Superiority |