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The effects of stopping long-term (7 years) and short term (2 years) risedronate therapy on BMD (bone mineral density) and BTMs (bone turnover markers) will be summarized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo/Risedronate | Placebo Comparator | Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8 |
|
| Risedronate | Active Comparator | Risedronate 5mg years 1-7, no drug year 8 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risedronate | Drug | 5 mg/day |
| |
| Placebo/Risedronate |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Core Study Baseline, Month 6, Intention to Treat (ITT) Population | Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2*BMD, Hologic sBMD = 1075.5*BMD. All scans analyzed centrally by Synarc (Portland, OR). | Baseline Core Study (Year 1) to Month 6 (Year 8) |
| Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12, ITT Population | Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2*BMD, Hologic sBMD = 1075.5*BMD. All scans analyzed centrally by Synarc (Portland, OR). | Baseline Core Study (Year 1) to Month 12 (Year 8) |
| Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12/Endpoint, ITT Population | Endpoint is the last measurement during the 12 month treatment period during Year 8. Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2*BMD, Hologic sBMD = 1075.5*BMD. All scans analyzed centrally by Synarc (Portland, OR). | Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8) |
| Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 6, ITT Population | Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR). | Baseline Core Study (Year 1) to Month 6 (Year 8) |
| Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12, ITT Population |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Herman Ellman, MD | Warner Chilcott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Concord | New South Wales | 2139 | Australia | ||
| Investigational Site |
Patients who sequentially completed Clinical Studies RVE009093 (3 year core study), RVE1996077 Year 4/5 extension study) and RVE1998080 (Year 6/7 extension study) were eligible for screening. [No NCT numbers available]
Screening began 4 October 2001
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/Risedronate | Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8 |
| FG001 | Risedronate | Risedronate 5mg years 1-7, no drug year 8 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo/Risedronate | Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8 |
| BG001 | Risedronate | Risedronate 5mg years 1-7, no drug year 8 |
| 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 | Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Core Study Baseline, Month 6, Intention to Treat (ITT) Population | Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2*BMD, Hologic sBMD = 1075.5*BMD. All scans analyzed centrally by Synarc (Portland, OR). | ITT Population | Posted | Mean | Standard Error | Percent Change | Baseline Core Study (Year 1) to Month 6 (Year 8) |
|
Twelve months treatment free period.
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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/Risedronate | Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accidental Injury | Injury, poisoning and procedural complications | COSTART | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back Pain | Musculoskeletal and connective tissue disorders | COSTART | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grexan J. Wulff, Manager Regulatory Affairs | Warner Chilcott | 973-442-3376 | gwulff@wcrx.com |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068296 | Risedronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Drug |
placebo years 1-5 followed by 5 mg risedronate years 6 & 7 and no drug year 8 |
|
Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).
| Baseline Core Study (Year 1) to Month 12 (Year 8) |
| Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12/Endpoint, ITT Population | Endpoint is the last measurement during the treatment period (thru Month 12, Year 8). Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR). | Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8) |
| Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 6, ITT Population | Month 6, Year 8 compared to Baseline, Year 1. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR). | Baseline Core Study (Year 1) to Month 6 (Year 8) |
| Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12, ITT Population | Baseline, year 1 compared with Month 12, year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR). | Baseline Core Study (Year 1) to Month 12 (Year 8) |
| Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12/Endpoint, ITT Population | Endpoint is the last measurement during the treatment period (through Month 12, Year 8) compared with baseline Year 1. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR). | Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8) |
| Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 6, ITT Population | Baseline, Year 1 compared with Month 6, Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR). | Baseline Core Study (Year 1) to Month 6 (Year 8) |
| Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12, ITT Population | Baseline, Year 1 compared with Month 12, Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR). | Baseline Core Study (Year 1) to Month 12 (Year 8) |
| Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12/Endpoint, ITT Population | Baseline, Year 1 compared with Endpoint (last measurement during the treatment period through Month 12), Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR). | Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8) |
| Parkville |
| Victoria |
| 3052 |
| Australia |
| Investigational Site | De Pintelaan 185 | Gent | B-9000 | Belgium |
| Investigational Site | Hvidovre | Denmark | DK-2650 | Denmark |
| Investigational Site | Oulu | Finland | SF-90 100 | Finland |
| Investigational Site | Siena | Italy | I-53100 | Italy |
| Investigational Site | Warsaw | Poland | PL 03-0335 | Poland |
| Investigational Site | Warsaw | Poland | PL-02315 | Poland |
| Investigational Site | Warsaw | Poland | PL-04-736 | Poland |
| Investigational Site | Warsaw | Poland | PL00-909 | Poland |
| Investigational Site | Barcelona | Spain | 08907 | Spain |
| Investigational Site | Madrid | Spain | 28040 | Spain |
| Investigational Site | Gothenburg | Sweden | S-411 32 | Sweden |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Customized | Number | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12, ITT Population | Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2*BMD, Hologic sBMD = 1075.5*BMD. All scans analyzed centrally by Synarc (Portland, OR). | ITT Population | Posted | Mean | Standard Error | Percent Change | Baseline Core Study (Year 1) to Month 12 (Year 8) |
|
|
|
| Primary | Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12/Endpoint, ITT Population | Endpoint is the last measurement during the 12 month treatment period during Year 8. Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2*BMD, Hologic sBMD = 1075.5*BMD. All scans analyzed centrally by Synarc (Portland, OR). | ITT Population | Posted | Mean | Standard Error | Percent Change | Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8) |
|
|
|
| Primary | Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 6, ITT Population | Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR). | ITT Population | Posted | Mean | Standard Error | Percent Change | Baseline Core Study (Year 1) to Month 6 (Year 8) |
|
|
|
| Primary | Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12, ITT Population | Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR). | ITT Population | Posted | Mean | Standard Error | Percent Change | Baseline Core Study (Year 1) to Month 12 (Year 8) |
|
|
|
| Primary | Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12/Endpoint, ITT Population | Endpoint is the last measurement during the treatment period (thru Month 12, Year 8). Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR). | ITT Population | Posted | Mean | Standard Error | Percent Change | Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8) |
|
|
|
| Primary | Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 6, ITT Population | Month 6, Year 8 compared to Baseline, Year 1. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR). | ITT Population | Posted | Mean | Standard Error | Percent Change | Baseline Core Study (Year 1) to Month 6 (Year 8) |
|
|
|
| Primary | Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12, ITT Population | Baseline, year 1 compared with Month 12, year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR). | ITT Population | Posted | Mean | Standard Error | Percent Change | Baseline Core Study (Year 1) to Month 12 (Year 8) |
|
|
|
| Primary | Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12/Endpoint, ITT Population | Endpoint is the last measurement during the treatment period (through Month 12, Year 8) compared with baseline Year 1. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR). | ITT Population | Posted | Mean | Standard Error | Percent Change | Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8) |
|
|
|
| Primary | Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 6, ITT Population | Baseline, Year 1 compared with Month 6, Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR). | ITT Population | Posted | Mean | Standard Error | Percent Change | Baseline Core Study (Year 1) to Month 6 (Year 8) |
|
|
|
| Primary | Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12, ITT Population | Baseline, Year 1 compared with Month 12, Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR). | ITT Population | Posted | Mean | Standard Error | Percent Change | Baseline Core Study (Year 1) to Month 12 (Year 8) |
|
|
|
| Primary | Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12/Endpoint, ITT Population | Baseline, Year 1 compared with Endpoint (last measurement during the treatment period through Month 12), Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR). | ITT Population | Posted | Mean | Standard Error | Percent Change | Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8) |
|
|
|
| 2 |
| 30 |
| 18 |
| 30 |
| EG001 | Risedronate | Risedronate 5mg years 1-7, no drug year 8 | 0 | 31 | 17 | 31 |
| Esophagitis | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Abscess | Infections and infestations | COSTART | Systematic Assessment |
|
| Asthenia | General disorders | COSTART | Systematic Assessment |
|
| Infection | Infections and infestations | COSTART | Systematic Assessment |
|
| Accidental Injury | Injury, poisoning and procedural complications | COSTART | Systematic Assessment |
|
| Chest Pain | General disorders | COSTART | Systematic Assessment |
|
| Headache | Nervous system disorders | COSTART | Systematic Assessment |
|
| Hernia | Injury, poisoning and procedural complications | COSTART | Systematic Assessment |
|
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | COSTART | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Depression | Nervous system disorders | COSTART | Systematic Assessment |
|
| Insomnia | Nervous system disorders | COSTART | Systematic Assessment |
|
| Neurosis | Nervous system disorders | COSTART | Systematic Assessment |
|
| Sleep Disorder | Nervous system disorders | COSTART | Systematic Assessment |
|
| Amnesia | Nervous system disorders | COSTART | Systematic Assessment |
|
| Confusion | Nervous system disorders | COSTART | Systematic Assessment |
|
| ExtraPyramidal Syndrome | Nervous system disorders | COSTART | Systematic Assessment |
|
| Hyperkinesia | Nervous system disorders | COSTART | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | COSTART | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | COSTART | Systematic Assessment |
|
| Vertigo | Nervous system disorders | COSTART | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | COSTART | Systematic Assessment |
|
| Hypertension | Cardiac disorders | COSTART | Systematic Assessment |
|
| Peripheral Vascular Disease | Cardiac disorders | COSTART | Systematic Assessment |
|
| Coronary Artery Disease | Cardiac disorders | COSTART | Systematic Assessment |
|
| Heart Failure | Cardiac disorders | COSTART | Systematic Assessment |
|
| Leg Cramps | Musculoskeletal and connective tissue disorders | COSTART | Systematic Assessment |
|
| Traumatic Bone Fracture | Musculoskeletal and connective tissue disorders | COSTART | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | COSTART | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | COSTART | Systematic Assessment |
|
| Arthrosis | Musculoskeletal and connective tissue disorders | COSTART | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | COSTART | Systematic Assessment |
|
| Bone Pain | Musculoskeletal and connective tissue disorders | COSTART | Systematic Assessment |
|
| Dermatologic Fungus | Skin and subcutaneous tissue disorders | COSTART | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | COSTART | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | COSTART | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | COSTART | Systematic Assessment |
|
| Amblyopia | Eye disorders | COSTART | Systematic Assessment |
|
| Glaucoma | Eye disorders | COSTART | Systematic Assessment |
|
| Vestibular Disorder | Ear and labyrinth disorders | COSTART | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Duodenitis | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Increased GGTP (Gamma Glutamyl Transpeptidase) | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Glossitis | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Iron Deficiency Anemia | Blood and lymphatic system disorders | COSTART | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | COSTART | Systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | COSTART | Systematic Assessment |
|
| Endometrial Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | COSTART | Systematic Assessment |
|
| Breast Pain | Reproductive system and breast disorders | COSTART | Systematic Assessment |
|
Not provided
| D009750 |
| Nutritional and Metabolic Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |