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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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The purpose of this trial is to compare the difference in bone microarchitecture of the distal radius at month 12 in postmenopausal osteopenic women treated with risedronate 150mg taken once a month compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Experimental | one 150 mg risedronate once a month, orally |
|
| 1 | Placebo Comparator | Placebo tablet once a month, orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | oral tablet once a month for 12 months |
| |
| risedronate |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Erosion Index (A Ratio of Curve-like Structures to Plate-like Structures and is a Measure of the Degree of Structural Degradation) of the Distal Radius | The percent was change from baseline in erosion index at the distal radius between the risedronate and placebo groups at Month 12 (the lower the percent change in erosion index, the greater the improvement of structural degradation); the last valid postbaseline measurement was to be used when the Month 12 value was missing (Last Observation Carried Forward or LOCF). NOTE: The study was unable to recruit sufficient numbers of patients to meet with the protocol specified numbers, thus it was terminated early after 5 months. No efficacy analyses were performed. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Erosion Index of the Distal Radius | Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana M Balske, MD, PhD | Procter and Gamble | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Facility | Tuscon | Arizona | 85704 | United States | ||
| Research Facility |
The Screening visit was conducted within 45 days of randomization. After obtaining written informed consent, patients underwent a preliminary screening, including Dual Energy X-ray Absorptiometry (DXA) of the lumbar spine and proximal femur. The most frequent reason for screening failure was DXA results.
Beginning with the first patient screened on June 18th, 2008, a total of 51 patients were screened for inclusion into the study, of which 38 were excluded from further participation.
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| ID | Title | Description |
|---|---|---|
| FG000 | One 150 mg Risedronate Once a Month | one 150 mg risedronate once a month, orally |
| FG001 | Placebo Tablet Once a Month | Placebo tablet once a month, orally |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | One 150 mg Risedronate Once a Month | one 150 mg risedronate once a month, orally |
| BG001 | Placebo Tablet Once a Month | Placebo tablet once a month, orally |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Percent Change From Baseline in Erosion Index (A Ratio of Curve-like Structures to Plate-like Structures and is a Measure of the Degree of Structural Degradation) of the Distal Radius | The percent was change from baseline in erosion index at the distal radius between the risedronate and placebo groups at Month 12 (the lower the percent change in erosion index, the greater the improvement of structural degradation); the last valid postbaseline measurement was to be used when the Month 12 value was missing (Last Observation Carried Forward or LOCF). NOTE: The study was unable to recruit sufficient numbers of patients to meet with the protocol specified numbers, thus it was terminated early after 5 months. No efficacy analyses were performed. | Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed. | Posted | 12 months |
|
From the point of study enrolment until the subject's last observation.
Specific safety parameters and procedures were to include vital signs, serum chemistry panel/hematology/urinalysis, and recording of AEs, including moderate-to-severe upper GI events and clinical fractures.
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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 | One 150 mg Risedronate Once a Month | one 150 mg risedronate once a month, orally |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | Abdominal distension | Non-systematic Assessment |
NOTE: The study was terminated early (after 5 months), prior to acquiring any efficacy endpoints; consequently, NO subject efficacy analyses were performed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grexan 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 |
tablet, 150 mg once a month for 12 months |
|
| Omaha |
| Nebraska |
| 68729 |
| United States |
| Research Site | Cincinnati | Ohio | 45201 | United States |
| Research Facility | Buenos Aires | Argentina |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
one 150 mg risedronate once a month, orally
| OG001 | Placebo Tablet Once a Month | Placebo tablet once a month, orally |
|
| Secondary | Erosion Index of the Distal Radius | Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed. | Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed. | Posted | 6 months |
|
|
| 0 |
| 7 |
| 2 |
| 7 |
| EG001 | Placebo Tablet Once a Month | Placebo tablet once a month, orally | 0 | 6 | 2 | 6 |
| Pharyngitis | General disorders | Pharyngitis | Non-systematic Assessment |
|
| Blood pressure increased | Cardiac disorders | Blood pressure incre | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | Ear infection | Non-systematic Assessment |
|
The Study Site and Principal Investigator agree that all data, calculations, interpretations, opinions, and recommendations regarding the study will be the property of the Sponsor. The Study Site and Principal Investigator agree to consider the results as confidential information subject to use restrictions.
The names of the Investigator(s) will not be used by P&GP for commercial purposes without appropriate written permission, unless required by law or government regulation.
| D009750 |
| Nutritional and Metabolic Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |