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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000290-31 | EudraCT Number |
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low recruitment rate
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| Name | Class |
|---|---|
| German Federal Ministry of Education and Research | OTHER_GOV |
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The purpose of this study is to evaluate the efficacy and safety of bisphosphonates in long term treatment of osteoporosis.
Is a continued treatment with alendronate for another two years after a preceding therapy with bisphosphonates of at least four years able to reduce the incidence of new osteoporotic fractures in patients at high fracture risk compared to a therapy-free interval?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alendronate | Active Comparator |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alendronate | Drug | 70 mg per week |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of New Osteoporotic Fractures | Number of new osteoporotic fractures. All fractures which occurred without high impact trauma (i.e. atraumatically, minor accidents and falls from standing height and lower) were regarded as osteoporotic fractures, except for fractures of fingers, face, skull and toes. | From baseline to study termination (mean duration 5.6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Number of deaths | From baseline to study termination (mean duration 5.6 months) |
| Combination of New Osteoporotic Fractures and Deaths | Number of participants with a new osteoporotic fracture or death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johannes Pfeilschifter, Prof. Dr. med. | Alfried Krupp Krankenhaus Essen Steele | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine III, Alfried Krupp Krankenhaus Essen Steele | Essen | 45276 | Germany |
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The study was early terminated due to a low recruitment rate
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo, administered orally once weekly |
| FG001 | Alendronate | Alendronate 70 mg, administered orally once weekly |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | 1 pill per week |
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| From baseline to study termination (mean duration 5.6 months) |
| Safety Analysis Set | Received at least one dose of study medication |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo, administered orally once weekly |
| BG001 | Alendronate | Alendronate 70 mg, administered orally once weekly |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | Number of New Osteoporotic Fractures | Number of new osteoporotic fractures. All fractures which occurred without high impact trauma (i.e. atraumatically, minor accidents and falls from standing height and lower) were regarded as osteoporotic fractures, except for fractures of fingers, face, skull and toes. | Full Analysis Set (all randomized participants) | Posted | Number | osteoporotic fractures | From baseline to study termination (mean duration 5.6 months) |
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| Secondary | Mortality | Number of deaths | Full Analysis Set (all randomized participants) | Posted | Count of Participants | Participants | From baseline to study termination (mean duration 5.6 months) |
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| Secondary | Combination of New Osteoporotic Fractures and Deaths | Number of participants with a new osteoporotic fracture or death | Full Analysis Set (all randomized participants) | Posted | Count of Participants | Participants | From baseline to study termination (mean duration 5.6 months) |
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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 | Placebo | Placebo, administered orally once weekly | 38 | 197 | 113 | 197 | ||
| EG001 | Alendronate | Alendronate 70 mg, administered orally once weekly | 31 | 188 | 94 | 188 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Microcytic anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Acute coronary syndrome | Cardiac disorders | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | Systematic Assessment |
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| Myocarditis | Cardiac disorders | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
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| Toxic nodular goitre | Endocrine disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
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| Diverticulitis | Gastrointestinal disorders | Systematic Assessment |
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| Gastric ulcer | Gastrointestinal disorders | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Pancreas infection | Gastrointestinal disorders | Systematic Assessment |
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| Impaired healing | General disorders | Systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| Liver disorder | Hepatobiliary disorders | Systematic Assessment |
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| Atypical femur fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Facial bones fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | Systematic Assessment | toe fracture |
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| Fractured sacrum | Injury, poisoning and procedural complications | Systematic Assessment | knowledge about one fractured sacrum was obtained post-study. |
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| Hand fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Hip fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | Systematic Assessment |
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| Pelvic fracture | Injury, poisoning and procedural complications | Systematic Assessment | 1 pelvic fracture occurred within 30 days after study termination |
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| Pubis fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Skull fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Spinal fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Sternal fracture | Injury, poisoning and procedural complications | Systematic Assessment | 1 high impact fracture |
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| Catheterisation cardiac | Investigations | Systematic Assessment |
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| Hysteroscopy | Investigations | Systematic Assessment |
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| Anaemia vitamin B12 deficiency | Metabolism and nutrition disorders | Systematic Assessment |
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| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Osteochondrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Sciatica | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Rectal adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Carotid artery stenosis | Nervous system disorders | Systematic Assessment |
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| Cerebellar infarction | Nervous system disorders | Systematic Assessment |
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| Syncope | Nervous system disorders | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | Systematic Assessment |
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| Urinary incontinence | Renal and urinary disorders | Systematic Assessment |
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| Endometrial hyperplasia | Reproductive system and breast disorders | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Angioplasty | Surgical and medical procedures | Systematic Assessment |
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| Aortic valve replacement | Surgical and medical procedures | Systematic Assessment |
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| Dupuytren's contracture operation | Surgical and medical procedures | Systematic Assessment |
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| Inguinal hernia repair | Surgical and medical procedures | Systematic Assessment |
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| Knee arthroplasty | Surgical and medical procedures | Systematic Assessment |
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| Peripheral artery angioplasty | Surgical and medical procedures | Systematic Assessment |
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| Salpingo-oophorectomy | Surgical and medical procedures | Systematic Assessment |
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| Shoulder operation | Surgical and medical procedures | Systematic Assessment |
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| Toe operation | Surgical and medical procedures | Systematic Assessment |
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| Tooth extraction | Surgical and medical procedures | Systematic Assessment |
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| Haematoma infection | Vascular disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Peripheral artery occlusion | Vascular disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Tooth disorder | Gastrointestinal disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Hyperhidrosis | General disorders | Systematic Assessment |
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| Oedema peripheral | General disorders | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Cutaneous symptom | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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Due to a low recruitment rate, the study was early terminated.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Johannes Pfeilschifter, MD | Ruhr-Universität Bochum | Johannes.Pfeilschifter@rub.de |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D058866 | Osteoporotic Fractures |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D019386 | Alendronate |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Male |
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