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This 3 arm study will evaluate renal safety after administration of an intravenous (iv) injection or infusion of Bonviva, compared to oral alendronate, in patients with postmenopausal osteoporosis, at increased risk of renal disease. Patients will be randomized to receive Bonviva 3mg intravenous (iv) by a) injection or b) infusion once every 3 months, or alendronate 70mg per oral (po) weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ibandronate [Bonviva/Boniva] | Drug | 3mg intravenous (iv) injection every 3 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula) | The primary parameter of the study was the change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patients' actual body surface area) after 9 months (or 40 weeks) of treatment. | Baseline and 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula) | Change (mL/min) from baseline in actual GFR (using Cockcroft-Gault [CG] formula) after 9 months (or 40 weeks) of treatment. | Baseline and 9 months |
| Relative Change From Baseline in Actual GFR (Using Abbreviated MDRD Formula) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35294 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34231877 | Derived | Hara T, Hijikata Y, Matsubara Y, Watanabe N. Pharmacological interventions versus placebo, no treatment or usual care for osteoporosis in people with chronic kidney disease stages 3-5D. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013424. doi: 10.1002/14651858.CD013424.pub2. |
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Total 801 participants randomized. Of the randomized patients, 263 who received at least one dose of ibandronate as an injection, 263 who received at least one dose of ibandronate as an infusion and 267 patients who received at least one dose of alendronate had at least one post-baseline assessment and were included in the safety analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ibandronate 3 mg Injection | Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months. |
| FG001 | Ibandronate 3 mg Infusion | Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ibandronate [Bonviva/Boniva] |
| Drug |
3mg intravenous (iv) infusion every 3 months |
|
| Alendronate | Drug | 70mg per oral (po) weekly |
|
Change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patient's actual body surface area) after 9 months (or 40 weeks) of treatment. |
| Baseline and 9 months |
| Relative Change From Baseline in Actual GFR (Using CG Formula) | Change (mL/min) from baseline in actual GFR (CG formula using the patient's actual body surface area) after 9 months (or 40 weeks) of treatment. | Baseline and 9 months |
| Absolute Change From Baseline in Mean Serum Creatinine. | Baseline and 9 months |
| Relative Change From Baseline in Mean Serum Creatinine. | Baseline and 9 months |
| Absolute Change From Baseline in Urine Albumin-to-Creatinine Ratio. | Baseline and 9 months |
| Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio. | The relative change from baseline in this case is positively skewed (while the absolute change is not) and the means tends to more positive values. | Baseline and 9 months |
| Riverside |
| California |
| 92505 |
| United States |
| Lakewood | Colorado | 80227 | United States |
| West Palm Beach | Florida | 33401 | United States |
| Gainesville | Georgia | 30501 | United States |
| Topeka | Kansas | 66604 | United States |
| Bethesda | Maryland | 20817 | United States |
| Omaha | Nebraska | 68131 | United States |
| Albuquerque | New Mexico | 87106 | United States |
| Morehead City | North Carolina | 28557 | United States |
| Bismarck | North Dakota | 58501 | United States |
| Fargo | North Dakota | 58103 | United States |
| Cincinnati | Ohio | 45224 | United States |
| Duncansville | Pennsylvania | 16635 | United States |
| Norfolk | Virginia | 23502 | United States |
| Buenos Aires | B1878DVB | Argentina |
| Buenos Aires | C1012-CFed | Argentina |
| Buenos Aires | C1117ABH | Argentina |
| Buenos Aires | C1128AAF | Argentina |
| Buenos Aires | C1405BCH | Argentina |
| Buenos Aires | C1425 AWC | Argentina |
| Buenos Aires | C1425AGC | Argentina |
| Córdoba | X5000BNB | Argentina |
| Santa Fe | 2000 | Argentina |
| Brasília | 71625-009 | Brazil |
| Curitiba | 80030-110 | Brazil |
| Goiânia | 74110-120 | Brazil |
| Porto Alegre | 90610-000 | Brazil |
| Rio de Janeiro | 22271-100 | Brazil |
| São Paulo | 04266-010 | Brazil |
| Vitória | 29055-450 | Brazil |
| Guadalajara | 44629 | Mexico |
| Mexico City | 11000 | Mexico |
| Monterrey | 64460 | Mexico |
| Obregón | 85000 | Mexico |
| San Jerónimo | 52170 | Mexico |
| Durban | 3630 | South Africa |
| Johannesburg | 2196 | South Africa |
| Parow | 7500 | South Africa |
| Port Elizabeth | 6001 | South Africa |
| Somerset West | 7130 | South Africa |
| Basel | 4055 | Switzerland |
| Bern | 3010 | Switzerland |
| Zurich | 8091 | Switzerland |
| FG002 | Alendronate 70 mg Oral | Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg). |
| Intent to Treat Population (ITT) |
|
| Per Protocol Population (PP) |
|
| Safety Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ibandronate 3 mg Injection | Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months. |
| BG001 | Ibandronate 3 mg Infusion | Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months. |
| BG002 | Alendronate 70 mg Oral | Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg). |
| BG003 | 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 |
|
| 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 | Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula) | The primary parameter of the study was the change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patients' actual body surface area) after 9 months (or 40 weeks) of treatment. | Per Protocol (PP) Population | Posted | Mean | Standard Deviation | mL/min | Baseline and 9 months |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula) | Change (mL/min) from baseline in actual GFR (using Cockcroft-Gault [CG] formula) after 9 months (or 40 weeks) of treatment. | PP Population | Posted | Mean | Standard Deviation | mL/min | Baseline and 9 months |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Relative Change From Baseline in Actual GFR (Using Abbreviated MDRD Formula) | Change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patient's actual body surface area) after 9 months (or 40 weeks) of treatment. | PP Population | Posted | Mean | Standard Deviation | mL/min | Baseline and 9 months |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Relative Change From Baseline in Actual GFR (Using CG Formula) | Change (mL/min) from baseline in actual GFR (CG formula using the patient's actual body surface area) after 9 months (or 40 weeks) of treatment. | PP Population | Posted | Mean | Standard Deviation | mL/min | Baseline and 9 months |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Absolute Change From Baseline in Mean Serum Creatinine. | PP Population | Posted | Mean | Standard Deviation | mg/dL | Baseline and 9 months |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Relative Change From Baseline in Mean Serum Creatinine. | PP Population | Posted | Mean | Standard Deviation | mg/dL | Baseline and 9 months |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change From Baseline in Urine Albumin-to-Creatinine Ratio. | PP Population | Posted | Mean | Standard Deviation | mg/g | Baseline and 9 months |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio. | The relative change from baseline in this case is positively skewed (while the absolute change is not) and the means tends to more positive values. | PP Population | Posted | Mean | Standard Deviation | mg/g | Baseline and 9 months |
|
|
AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
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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 | Ibandronate 3 mg Injection | Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months. | 19 | 263 | 196 | 263 | ||
| EG001 | Ibandronate 3 mg Infusion | Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months. | 15 | 263 | 190 | 263 | ||
| EG002 | Alendronate 70 mg Oral | Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg). | 13 | 267 | 191 | 267 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Head Injury | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Multiple Drug Overdose Accidental | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Multiple Fractures | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Traumatic Brain Injury | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Vascular Pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Acute Coronary Syndrome | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Conduction Disorder | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Supraventricular Tachycardia | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Abdominal Abscess | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Peptic Ulcer Perforation | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
| |
| Breast Cancer Stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
| |
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Ischemic Stroke | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Ruptured Cerebral Aneurysm | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Senile Dementia | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Subarachnoid Haemorrhage | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hypertensive Crisis | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Temporal Arteritis | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Autoimmune Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Electrolyte Imbalance | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Breast Mass | Reproductive system and breast disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Dyspepsia | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Dyslipidemia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Glomerular Filtration Rate Decreased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Labyrinthitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Gastroesophageal Reflux Disease | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffman-LaRoche | 800-821-8590 |
| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077557 | Ibandronic Acid |
| D019386 | Alendronate |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Male |
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