EDGE: Effectiveness of DiscontinuinG bisphosphonatEs Study: R21 Pilot Study

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT02139007
• Collaborator: (none)
• Enrollment: 27
• Location: 1
• Arms: 2
• Actual Duration (Months): 25
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Drug: Alendronate	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effectiveness of DiscontinuinG bisphosphonatEs Study: R21 Pilot Study
• Actual Study Start Date: Jun 1, 2014
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Continuation Arm Alendronate continuation arm	Drug: Alendronate
Active Comparator: Discontinuation Arm Alendronate discontinuation arm	Drug: Alendronate

Outcome Measures

Primary Outcome Measures

1. 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

2. All Study Sites--Length of Time to Site IRB Approval [Length of time to site IRB approval]

   Mean time to gain site IRB approval

3. 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 Outcome Measures

1. Clinical Fracture Rate [Baseline to 6 months following enrollment]

   Patient reported fracture rate at 6 months following enrollment via survey.

2. Atypical Femoral Fracture [Baseline to 6 months following enrollment]

   Patient reported fracture rate at 6 months after enrollment via follow-up survey

3. 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 .

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 100 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1.Females 65+

2.3+ years of alendronate (Fosamax/Binosto) use

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

• University of Alabama at Birmingham

Investigators

• Principal Investigator: Kenneth G Saag, MD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kenneth Saag, MD, MSc, Professor of Medicine, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT02139007
• Other Study ID Numbers: F120404006
• First Posted: May 15, 2014
• Last Update Posted: May 12, 2017
• Last Verified: Apr 1, 2017

• Additional relevant MeSH terms: Osteoporosis; Alendronate

Study Results

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 Detail	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.

Arm/Group Title	Continuation Arm	Discontinuation Arm
Arm/Group Description	Alendronate continuation arm Participants were randomized to continue their current alendronate prescription at prescribed dose.	Alendronate discontinuation arm Participants were randomized to stop taking their current alendronate prescription.
Period Title: Study Site Recruitment
STARTED	4	5
COMPLETED	1	1
NOT COMPLETED	3	4
Period Title: Study Site Recruitment
STARTED	13	14
COMPLETED	11	13
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Continuation Arm	Discontinuation Arm	Total
Arm/Group Description	Alendronate continuation arm	Alendronate discontinuation arm	Total of all reporting groups
Overall Participants	13	14	27
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	13 100%	14 100%	27 100%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	74.4 (6.7)	74.5 (5.9)	74.5 (6.1)
Sex: Female, Male (Count of Participants)
Female	13 100%	14 100%	27 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 15.4%	3 21.4%	5 18.5%
White	10 76.9%	9 64.3%	19 70.4%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 7.7%	2 14.3%	3 11.1%
Region of Enrollment (participants) [Number]
United States	13 100%	14 100%	27 100%
Previous History of Fracture (Count of Participants)
Count of Participants [Participants]	5 38.5%	5 35.7%	10 37%
Duration of Alendronate Use (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	4.8 (2.1)	5.3 (3.1)	5.1 (17)

Outcome Measures

1. Primary Outcome

Title	All Study Sites--Length of Contracting Procedures
Description	Mean time Between Clinical Site Recruitment and Contract Execution
Time Frame	Length of time Between Clinical Site Recruitment and Contract Execution

Outcome Measure Data

Analysis Population Description

Nine sites from six states (AL, CO, NM, CT, CA, and PA) participated in this pilot study.

Arm/Group Title	All Study Sites -- Contracting Procedures
Arm/Group Description	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. .
Measure Participants	9
Measure Sites	9
Mean (Standard Deviation) [Months]	3.4 (2.3)

2. Primary Outcome

Title	All Study Sites--Length of Time to Site IRB Approval
Description	Mean time to gain site IRB approval
Time Frame	Length of time to site IRB approval

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Study Sites --IRB Approval
Arm/Group Description	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. .
Measure Participants	9
Measure Sites	9
Mean (Standard Deviation) [Days]	13.9 (4.1)

3. Primary Outcome

Title	All Study Sites-Length of Time to 1st Participant Enrolled
Description	Mean time from study initiation to 1st participant enrolled.
Time Frame	Length of time t for sites to recruit/enroll 1st participant

Outcome Measure Data

Analysis Population Description

For sites enrolling at least one patient, the average (SD) time from contract execution to the first patient recruited.

Arm/Group Title	All Study Sites-Initiation to the First Participant Recruited
Arm/Group Description	study initiation to the first participant recruited
Measure Participants	9
Measure Sites	9
Mean (Standard Deviation) [Months]	5.0 (3.0)

4. Secondary Outcome

Title	Clinical Fracture Rate
Description	Patient reported fracture rate at 6 months following enrollment via survey.
Time Frame	Baseline to 6 months following enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Continuation Arm	Discontinuation Arm
Arm/Group Description	Alendronate continuation arm Alendronate	Alendronate discontinuation arm Alendronate
Measure Participants	11	13
Count of Participants [Participants]	0 0%	0 0%

5. Secondary Outcome

Title	Atypical Femoral Fracture
Description	Patient reported fracture rate at 6 months after enrollment via follow-up survey
Time Frame	Baseline to 6 months following enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Continuation Arm	Discontinuation Arm
Arm/Group Description	Alendronate continuation arm Alendronate	Alendronate discontinuation arm Alendronate
Measure Participants	11	13
Count of Participants [Participants]	0 0%	0 0%

6. Secondary Outcome

Title	Osteonecrosis of the Jaw
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Continuation Arm	Discontinuation Arm
Arm/Group Description	Alendronate continuation arm Alendronate	Alendronate discontinuation arm Alendronate
Measure Participants	11	13
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Time Frame	Baseline to 6 months following enrollment
Arm/Group Title	Continuation Arm		Discontinuation Arm
Arm/Group Description	Alendronate continuation arm Alendronate		Alendronate discontinuation arm Alendronate
All Cause Mortality
	Continuation Arm		Discontinuation Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/13 (0%)
Serious Adverse Events
	Continuation Arm		Discontinuation Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/13 (0%)
Other (Not Including Serious) Adverse Events
	Continuation Arm		Discontinuation Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/13 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.