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This is a pilot study evaluating the recruitment strategies for sites and patients, data collection instruments, follow-up procedures, administrative processes, and the proposed management strategy for the future large scale national trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuation Arm | Active Comparator | Alendronate continuation arm |
|
| Discontinuation Arm | Active Comparator | Alendronate discontinuation arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alendronate | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| All Study Sites--Length of Contracting Procedures | Mean time Between Clinical Site Recruitment and Contract Execution | Length of time Between Clinical Site Recruitment and Contract Execution |
| All Study Sites--Length of Time to Site IRB Approval | Mean time to gain site IRB approval | Length of time to site IRB approval |
| All Study Sites-Length of Time to 1st Participant Enrolled | Mean time from study initiation to 1st participant enrolled. | Length of time t for sites to recruit/enroll 1st participant |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Fracture Rate | Patient reported fracture rate at 6 months following enrollment via survey. | Baseline to 6 months following enrollment |
| Atypical Femoral Fracture | Patient reported fracture rate at 6 months after enrollment via follow-up survey |
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Inclusion Criteria:
1.Females 65+
2.3+ years of alendronate (Fosamax/Binosto) use
3. Valid social security number
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth G Saag, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
Period 1 refers to the study site recruitment period for the 9 sites that participated in the study. Period 2 refers to the patient recruitment period for the study. Randomization to treatment assignment was at the patient level. Sites recruited patient participants to both arms of the study. Two sites failed to enroll participants in either arm.
Sites were selected from 2 practice based research networks based upon self-reporting having a large number of women ≥ 65 years of age with a current alendronate prescription. Enrolled patient participants were randomized to continue or discontinue their current prescription. No drug was provided.
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| ID | Title | Description |
|---|---|---|
| FG000 | Continuation Arm | Alendronate continuation arm Participants were randomized to continue their current alendronate prescription at prescribed dose. |
| FG001 | Discontinuation Arm | Alendronate discontinuation arm Participants were randomized to stop taking their current alendronate prescription. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study Site Recruitment |
| |||||||||||||
| Patient Participant Recruitment |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Continuation Arm | Alendronate continuation arm |
| BG001 | Discontinuation Arm | Alendronate discontinuation arm |
| 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 | All Study Sites--Length of Contracting Procedures | Mean time Between Clinical Site Recruitment and Contract Execution | Nine sites from six states (AL, CO, NM, CT, CA, and PA) participated in this pilot study. | Posted | Mean | Standard Deviation | Months | Length of time Between Clinical Site Recruitment and Contract Execution | Sites | Sites |
|
Baseline to 6 months following enrollment
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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 | Continuation Arm | Alendronate continuation arm Alendronate | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeff Foster | UAB | 205-996-6086 | pjfoster@uabmc.edu |
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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 |
|---|---|
| D019386 | Alendronate |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Baseline to 6 months following enrollment |
| Osteonecrosis of the Jaw | Patients self report diagnoses of osteonecrosis of the jaw 6 months post enrollment via follow-up survey . | Baseline to 6 months following enrollment |
| NOT COMPLETED |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Previous History of Fracture | Count of Participants | Participants |
|
| Duration of Alendronate Use | Mean | Standard Deviation | Years |
|
| Units | Counts |
|---|
| Participants |
|
| Sites |
|
|
| Primary | All Study Sites--Length of Time to Site IRB Approval | Mean time to gain site IRB approval | Posted | Mean | Standard Deviation | Days | Length of time to site IRB approval | Sites | Sites |
|
|
|
| Primary | All Study Sites-Length of Time to 1st Participant Enrolled | Mean time from study initiation to 1st participant enrolled. | For sites enrolling at least one patient, the average (SD) time from contract execution to the first patient recruited. | Posted | Mean | Standard Deviation | Months | Length of time t for sites to recruit/enroll 1st participant | Sites | Sites |
|
|
|
| Secondary | Clinical Fracture Rate | Patient reported fracture rate at 6 months following enrollment via survey. | Posted | Count of Participants | Participants | Baseline to 6 months following enrollment |
|
|
|
| Secondary | Atypical Femoral Fracture | Patient reported fracture rate at 6 months after enrollment via follow-up survey | Posted | Count of Participants | Participants | Baseline to 6 months following enrollment |
|
|
|
| Secondary | Osteonecrosis of the Jaw | Patients self report diagnoses of osteonecrosis of the jaw 6 months post enrollment via follow-up survey . | Posted | Count of Participants | Participants | Baseline to 6 months following enrollment |
|
|
|
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Discontinuation Arm | Alendronate discontinuation arm Alendronate | 0 | 13 | 0 | 13 | 0 | 13 |
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| D009750 |
| Nutritional and Metabolic Diseases |