Trial Outcomes & Findings for Effectiveness of DiscontinuinG bisphosphonatEs Study: R21 Pilot Study (NCT NCT02139007)
NCT ID: NCT02139007
Last Updated: 2017-05-12
Results Overview
Mean time Between Clinical Site Recruitment and Contract Execution
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
27 participants
Primary outcome timeframe
Length of time Between Clinical Site Recruitment and Contract Execution
Results posted on
2017-05-12
Participant Flow
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.
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.
Participant milestones
| Measure |
Continuation Arm
Alendronate continuation arm
Participants were randomized to continue their current alendronate prescription at prescribed dose.
|
Discontinuation Arm
Alendronate discontinuation arm
Participants were randomized to stop taking their current alendronate prescription.
|
|---|---|---|
|
Study Site Recruitment
STARTED
|
4
|
5
|
|
Study Site Recruitment
COMPLETED
|
1
|
1
|
|
Study Site Recruitment
NOT COMPLETED
|
3
|
4
|
|
Patient Participant Recruitment
STARTED
|
13
|
14
|
|
Patient Participant Recruitment
COMPLETED
|
11
|
13
|
|
Patient Participant Recruitment
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of DiscontinuinG bisphosphonatEs Study: R21 Pilot Study
Baseline characteristics by cohort
| Measure |
Continuation Arm
n=13 Participants
Alendronate continuation arm
|
Discontinuation Arm
n=14 Participants
Alendronate discontinuation arm
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Continuous
|
74.4 Years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
74.5 Years
STANDARD_DEVIATION 5.9 • n=7 Participants
|
74.5 Years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Previous History of Fracture
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Duration of Alendronate Use
|
4.8 Years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
5.3 Years
STANDARD_DEVIATION 3.1 • n=7 Participants
|
5.1 Years
STANDARD_DEVIATION 17 • n=5 Participants
|
PRIMARY outcome
Timeframe: Length of time Between Clinical Site Recruitment and Contract ExecutionPopulation: Nine sites from six states (AL, CO, NM, CT, CA, and PA) participated in this pilot study.
Mean time Between Clinical Site Recruitment and Contract Execution
Outcome measures
| Measure |
All Study Sites -- Contracting Procedures
n=9 Sites
The duration of time from execution of contracts, IRB approval, and to participant recruitment is potential contributor to overall suboptimal recruitment in clinical research. In this pilot study we measured the mean duration of administrative procedures for sites to the first patient enrolled. .
|
Discontinuation Arm
Alendronate discontinuation arm
Alendronate
|
|---|---|---|
|
All Study Sites--Length of Contracting Procedures
|
3.4 Months
Standard Deviation 2.3
|
—
|
PRIMARY outcome
Timeframe: Length of time to site IRB approvalMean time to gain site IRB approval
Outcome measures
| Measure |
All Study Sites -- Contracting Procedures
n=9 Sites
The duration of time from execution of contracts, IRB approval, and to participant recruitment is potential contributor to overall suboptimal recruitment in clinical research. In this pilot study we measured the mean duration of administrative procedures for sites to the first patient enrolled. .
|
Discontinuation Arm
Alendronate discontinuation arm
Alendronate
|
|---|---|---|
|
All Study Sites--Length of Time to Site IRB Approval
|
13.9 Days
Standard Deviation 4.1
|
—
|
PRIMARY outcome
Timeframe: Length of time t for sites to recruit/enroll 1st participantPopulation: For sites enrolling at least one patient, the average (SD) time from contract execution to the first patient recruited.
Mean time from study initiation to 1st participant enrolled.
Outcome measures
| Measure |
All Study Sites -- Contracting Procedures
n=9 Sites
The duration of time from execution of contracts, IRB approval, and to participant recruitment is potential contributor to overall suboptimal recruitment in clinical research. In this pilot study we measured the mean duration of administrative procedures for sites to the first patient enrolled. .
|
Discontinuation Arm
Alendronate discontinuation arm
Alendronate
|
|---|---|---|
|
All Study Sites-Length of Time to 1st Participant Enrolled
|
5.0 Months
Standard Deviation 3.0
|
—
|
SECONDARY outcome
Timeframe: Baseline to 6 months following enrollmentPatient reported fracture rate at 6 months following enrollment via survey.
Outcome measures
| Measure |
All Study Sites -- Contracting Procedures
n=11 Participants
The duration of time from execution of contracts, IRB approval, and to participant recruitment is potential contributor to overall suboptimal recruitment in clinical research. In this pilot study we measured the mean duration of administrative procedures for sites to the first patient enrolled. .
|
Discontinuation Arm
n=13 Participants
Alendronate discontinuation arm
Alendronate
|
|---|---|---|
|
Clinical Fracture Rate
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to 6 months following enrollmentPatient reported fracture rate at 6 months after enrollment via follow-up survey
Outcome measures
| Measure |
All Study Sites -- Contracting Procedures
n=11 Participants
The duration of time from execution of contracts, IRB approval, and to participant recruitment is potential contributor to overall suboptimal recruitment in clinical research. In this pilot study we measured the mean duration of administrative procedures for sites to the first patient enrolled. .
|
Discontinuation Arm
n=13 Participants
Alendronate discontinuation arm
Alendronate
|
|---|---|---|
|
Atypical Femoral Fracture
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to 6 months following enrollmentPatients self report diagnoses of osteonecrosis of the jaw 6 months post enrollment via follow-up survey .
Outcome measures
| Measure |
All Study Sites -- Contracting Procedures
n=11 Participants
The duration of time from execution of contracts, IRB approval, and to participant recruitment is potential contributor to overall suboptimal recruitment in clinical research. In this pilot study we measured the mean duration of administrative procedures for sites to the first patient enrolled. .
|
Discontinuation Arm
n=13 Participants
Alendronate discontinuation arm
Alendronate
|
|---|---|---|
|
Osteonecrosis of the Jaw
|
0 Participants
|
0 Participants
|
Adverse Events
Continuation Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Discontinuation Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place