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Randomized, multicenter, double-blind, double-dummy, active-controlled, parallel-design study in approximately 201 postmenopausal women. A subset of subjects (approximately 102) will also participate in a pharmacokinetic (PK) component of the study. Each subject will be randomized to 1 of 3 treatment regimens for 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 150 mg | Active Comparator | 150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast. |
|
| 75 mg | Experimental | 75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast |
|
| 100 mg | Experimental | 100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 150 mg | Drug | 150 mg immediate release (IRBB) risedronate tablet administered orally at least 30 minutes before breakfast. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline Serum Type-1 Collagen C-telopeptide (CTX) 75 mg & 100 mg DRFB Tablet Compared With 150 mg IRBB Tablet, Month 4, ITT Population | Fasting serum Bone turn-over marker specimen assayed by electochemiluminescence. | Month 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population | 2 months | |
| Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chantell Wilson, PhD | Procter and Gamble | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Daytona Beach | Florida | 32117 | United States | ||
| Research Site |
Not provided
Screening began 27 May 2009
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| ID | Title | Description |
|---|---|---|
| FG000 | 150 mg | 150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast. |
| FG001 | 75 mg | 75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast |
| FG002 | 100 mg | 100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 150 mg | 150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast. |
| BG001 | 75 mg | 75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | ITT Population |
| 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 | Percentage Change From Baseline Serum Type-1 Collagen C-telopeptide (CTX) 75 mg & 100 mg DRFB Tablet Compared With 150 mg IRBB Tablet, Month 4, ITT Population | Fasting serum Bone turn-over marker specimen assayed by electochemiluminescence. | ITT Population | Posted | Least Squares Mean | Standard Error | Percent Change from Baseline | Month 4 |
|
27 May 2009 thru 23 October 2009, 5 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 | 150 mg | 150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grexan Wulff, Manager, Regulatory Affairs | Warner Chilcott | 973-442-3376 | gwulff@wcrx.com |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| 75 mg | Drug | 75 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast |
|
| 100 mg | Drug | 100 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast |
|
| Percent Change From Baseline Urine NTX (Type-1 Collagen Cross-linked N-telopeptide) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population | Urine NTX Bone turnover marker collected after 8 hour fast, 2nd voided urine between 6-9 am assayed by ELISA. | 2 months |
| Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population | ITT Population | 3 months |
| Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population | ITT Population | 4 months |
| Serum Bone Specific Alkaline Phosphatase (BAP) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population | ITT Population | 2 months |
| Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population | ITT Population | 3 months |
| Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population | ITT Population | 4 months |
| Fort Myers |
| Florida |
| 33901 |
| United States |
| Research Site | Honolulu | Hawaii | 96821 | United States |
| Research Site | Evansville | Indiana | 47711 | United States |
| Research Site | Austin | Texas | 78727 | United States |
| Research Site | Dallas | Texas | 75247 | United States |
| Withdrawal by Subject |
|
| No Study Medication Taken |
|
| BG002 | 100 mg | 100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast |
| BG003 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Age, Customized | ITT Population - Total 204 | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | ITT Population | Number | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 100 mg | 100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast |
|
|
|
| Secondary | Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population | ITT Population | Posted | Least Squares Mean | Standard Error | Percent Change from Baseline | 2 months |
|
|
|
|
| Secondary | Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population | ITT Population | Posted | Least Squares Mean | Standard Error | Percent Change from Baseline | 3 months |
|
|
|
|
| Secondary | Percent Change From Baseline Urine NTX (Type-1 Collagen Cross-linked N-telopeptide) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population | Urine NTX Bone turnover marker collected after 8 hour fast, 2nd voided urine between 6-9 am assayed by ELISA. | ITT Population | Posted | Least Squares Mean | Standard Error | Percent Change from Baseline | 2 months |
|
|
|
|
| Secondary | Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population | ITT Population | ITT Population | Posted | Least Squares Mean | Standard Error | Percent Change from Baseline | 3 months |
|
|
|
|
| Secondary | Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population | ITT Population | ITT Population | Posted | Least Squares Mean | Standard Error | Percent Change from Baseline | 4 months |
|
|
|
|
| Secondary | Serum Bone Specific Alkaline Phosphatase (BAP) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population | ITT Population | ITT Population | Posted | Least Squares Mean | Standard Error | Percent Change from Baseline | 2 months |
|
|
|
|
| Secondary | Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population | ITT Population | ITT Population | Posted | Least Squares Mean | Standard Error | Percent Change from Baseline | 3 months |
|
|
|
|
| Secondary | Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population | ITT Population | ITT Population | Posted | Least Squares Mean | Standard Error | Percent Change from Baseline | 4 months |
|
|
|
|
| 0 |
| 69 |
| 50 |
| 69 |
| EG001 | 75 mg | 75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast | 0 | 66 | 43 | 66 |
| EG002 | 100 mg | 100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast | 0 | 69 | 49 | 69 |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abnormal Faeces | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Frequent Bowel Movements | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Chest Discomfort | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Oopharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Viral Infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Muscle Strain | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
Not provided
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Fixed effects for treatment and center. |
| 0.9650 |
| LS Mean Difference |
| -0.218 |
| Standard Error of the Mean |
| 4.966 |
| 2-Sided |
| 90 |
| -8.427 |
| 7.991 |
| No |
| Superiority or Other |
Fixed effects for treatment and center. |
| 0.0133 |
| LS Mean Difference |
| -10.787 |
| Standard Error of the Mean |
| 4.313 |
| 2-Sided |
| 90 |
| -17.917 |
| -3.657 |
| No |
| Superiority or Other |
Fixed effects for treatment and center. |
| 0.1298 |
| LS Mean Difference |
| 14.215 |
| Standard Error of the Mean |
| 9.343 |
| 2-Sided |
| 90 |
| -1.230 |
| 29.659 |
| No |
| Superiority or Other |
Fixed effects for treatment and center. |
| 0.2291 |
| LS Mean Difference |
| -7.393 |
| Standard Error of the Mean |
| 6.126 |
| 2-Sided |
| 90 |
| -17.522 |
| 2.737 |
| No |
| Superiority or Other |
Fixed effects for treatment and center. |
| 0.9201 |
| LS Mean Difference |
| -0.914 |
| Standard Error of the Mean |
| 9.100 |
| 2-Sided |
| 90 |
| -15.959 |
| 14.132 |
| No |
| Superiority or Other |
Fixed effects for treatment and center. |
| 0.2349 |
| LS Mean Difference |
| 4.842 |
| Standard Error of the Mean |
| 4.063 |
| 2-Sided |
| 90 |
| -1.874 |
| 11.559 |
| No |
| Superiority or Other |
Fixed effects for treatment and center.
| 0.2613 |
| LS Mean Difference |
| 4.926 |
| Standard Error of the Mean |
| 4.371 |
| 2-Sided |
| 90 |
| -2.301 |
| 12.153 |
| No |
| Superiority or Other |
Fixed effects for treatment and center.
| 0.5006 |
| LS Mean Difference |
| -2.825 |
| Standard Error of the Mean |
| 4.185 |
| 2-Sided |
| 90 |
| -9.744 |
| 4.095 |
| No |
| Superiority or Other |