Osteoporosis
Conditions
Brief summary
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.
Interventions
DRUGAlendronate
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
65 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1.Females 65+ 2.3+ years of alendronate (Fosamax/Binosto) use 3\. Valid social security number
Exclusion criteria
1. History of any other metabolic bone condition, such as Paget Disease of Bone 2. Currently receiving treatment for ongoing cancer, excluding non-melanoma skin cancer. 3. Has significant underlying illness that would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to less than 3 years)? 4. HIV positive 5. Involved in a conflicting (investigational drug) clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All Study Sites--Length of Contracting Procedures | Length of time Between Clinical Site Recruitment and Contract Execution | Mean time Between Clinical Site Recruitment and Contract Execution |
| All Study Sites--Length of Time to Site IRB Approval | Length of time to site IRB approval | Mean time to gain site IRB approval |
| All Study Sites-Length of Time to 1st Participant Enrolled | Length of time t for sites to recruit/enroll 1st participant | Mean time from study initiation to 1st participant enrolled. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Fracture Rate | Baseline to 6 months following enrollment | Patient reported fracture rate at 6 months following enrollment via survey. |
| Atypical Femoral Fracture | Baseline to 6 months following enrollment | Patient reported fracture rate at 6 months after enrollment via follow-up survey |
| Osteonecrosis of the Jaw | Baseline to 6 months following enrollment | Patients self report diagnoses of osteonecrosis of the jaw 6 months post enrollment via follow-up survey . |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Continuation Arm Alendronate continuation arm | 13 |
| Discontinuation Arm Alendronate discontinuation arm | 14 |
| Total | 27 |
Baseline characteristics
| Characteristic | Continuation Arm | Discontinuation Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 14 Participants | 27 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 74.4 Years STANDARD_DEVIATION 6.7 | 74.5 Years STANDARD_DEVIATION 5.9 | 74.5 Years STANDARD_DEVIATION 6.1 |
| Duration of Alendronate Use | 4.8 Years STANDARD_DEVIATION 2.1 | 5.3 Years STANDARD_DEVIATION 3.1 | 5.1 Years STANDARD_DEVIATION 17 |
| Previous History of Fracture | 5 Participants | 5 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) White | 10 Participants | 9 Participants | 19 Participants |
| Region of Enrollment United States | 13 participants | 14 participants | 27 participants |
| Sex: Female, Male Female | 13 Participants | 14 Participants | 27 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 13 |
| other Total, other adverse events | 0 / 11 | 0 / 13 |
| serious Total, serious adverse events | 0 / 11 | 0 / 13 |
Outcome results
Primary
All Study Sites--Length of Contracting Procedures
Mean time Between Clinical Site Recruitment and Contract Execution
Time frame: Length of time Between Clinical Site Recruitment and Contract Execution
Population: Nine sites from six states (AL, CO, NM, CT, CA, and PA) participated in this pilot study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Study Sites -- Contracting Procedures | All Study Sites--Length of Contracting Procedures | 3.4 Months | Standard Deviation 2.3 |
Primary
All Study Sites-Length of Time to 1st Participant Enrolled
Mean time from study initiation to 1st participant enrolled.
Time frame: Length of time t for sites to recruit/enroll 1st participant
Population: For sites enrolling at least one patient, the average (SD) time from contract execution to the first patient recruited.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Study Sites -- Contracting Procedures | All Study Sites-Length of Time to 1st Participant Enrolled | 5.0 Months | Standard Deviation 3 |
Primary
All Study Sites--Length of Time to Site IRB Approval
Mean time to gain site IRB approval
Time frame: Length of time to site IRB approval
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Study Sites -- Contracting Procedures | All Study Sites--Length of Time to Site IRB Approval | 13.9 Days | Standard Deviation 4.1 |
Secondary
Atypical Femoral Fracture
Patient reported fracture rate at 6 months after enrollment via follow-up survey
Time frame: Baseline to 6 months following enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Study Sites -- Contracting Procedures | Atypical Femoral Fracture | 0 Participants |
| Discontinuation Arm | Atypical Femoral Fracture | 0 Participants |
Secondary
Clinical Fracture Rate
Patient reported fracture rate at 6 months following enrollment via survey.
Time frame: Baseline to 6 months following enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Study Sites -- Contracting Procedures | Clinical Fracture Rate | 0 Participants |
| Discontinuation Arm | Clinical Fracture Rate | 0 Participants |
Secondary
Osteonecrosis of the Jaw
Patients self report diagnoses of osteonecrosis of the jaw 6 months post enrollment via follow-up survey .
Time frame: Baseline to 6 months following enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Study Sites -- Contracting Procedures | Osteonecrosis of the Jaw | 0 Participants |
| Discontinuation Arm | Osteonecrosis of the Jaw | 0 Participants |