OsteoporosisPhase 4EDGENCT02139007
Effectiveness of DiscontinuinG bisphosphonatEs Study: R21 Pilot Study
A Phase 4 study testing Alendronate in people with Osteoporosis, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 100 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Alendronate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jul 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 1.Females 65+
- 2.3+ years of alendronate (Fosamax/Binosto) use
- 3. Valid social security number
Who cannot join
- History of any other metabolic bone condition, such as Paget Disease of Bone
- Currently receiving treatment for ongoing cancer, excluding non-melanoma skin cancer.
- 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)?
- HIV positive
- Involved in a conflicting (investigational drug) clinical trial
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
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.
- Conditions
- Osteoporosis
- Being tested
- Alendronate
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlendronateDrug
| Study group | Role | What they receive |
|---|---|---|
| Continuation Arm | Active comparator | Alendronate continuation arm Receives: Drug: Alendronate |
| Discontinuation Arm | Active comparator | Alendronate discontinuation arm Receives: Drug: Alendronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
All Study Sites--Length of Contracting Procedures
Mean time Between Clinical Site Recruitment and Contract Execution
Measured: 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
Measured: 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.
Measured: Length of time t for sites to recruit/enroll 1st participant
Secondary outcomes (3)
Clinical Fracture Rate
Patient reported fracture rate at 6 months following enrollment via survey.
Measured: Baseline to 6 months following enrollment
Atypical Femoral Fracture
Patient reported fracture rate at 6 months after enrollment via follow-up survey
Measured: 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 .
Measured: Baseline to 6 months following enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Saag, MD, MSc, University of Alabama at Birmingham
- Investigators
- Kenneth G Saag, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139007
- Sponsor's protocol ID
- F120404006
- Acronym
- EDGE
- Status last verified
- Apr 2017
- First submitted
- 13 May 2014
- Last updated
- 12 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of DiscontinuinG bisphosphonatEs Study: R21 Pilot Study
- ClinicalTrials.gov ID
- NCT02139007
- Acronym / sponsor ID
- EDGE / F120404006
- Conditions
- Osteoporosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 15 May 2014 (estimated)
- Results
- Posted 12 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuation Arm | Active comparator | Drug: AlendronateAlendronate continuation arm |
| Discontinuation Arm | Active comparator | Drug: AlendronateAlendronate discontinuation arm |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 1.Females 65+
- 2.3+ years of alendronate (Fosamax/Binosto) use
- 3. Valid social security number
Key exclusion criteria (5 listed)
- History of any other metabolic bone condition, such as Paget Disease of Bone
- Currently receiving treatment for ongoing cancer, excluding non-melanoma skin cancer.
- 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)?
- HIV positive
- Involved in a conflicting (investigational drug) clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alendronate | Drug | Continuation Arm, Discontinuation Arm |
Primary outcome
All Study Sites--Length of Contracting Procedures
Time frame: 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
Time frame: Length of time to site IRB approval
Mean time to gain site IRB approval
All Study Sites-Length of Time to 1st Participant Enrolled
Time frame: Length of time t for sites to recruit/enroll 1st participant
Mean time from study initiation to 1st participant enrolled.
3 secondary outcomes
Clinical Fracture Rate
Time frame: Baseline to 6 months following enrollment
Atypical Femoral Fracture
Time frame: Baseline to 6 months following enrollment
Osteonecrosis of the Jaw
Time frame: Baseline to 6 months following enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Osteoporosis
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis
RecruitingObservational study
Glucocorticoid-induced Osteoporosis in Patients With Chronic Inflammatory Rheumatic Diseases or Psoriasis
Osteoporosis, Inflammatory Rheumatism
Not yet recruiting
Exercise and Fall Prevention for Fracture Reduction
Osteopenia, Osteoporosis
Active, not recruiting
Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes
Type 2 Diabetes, Osteoporosis
Recruiting
Surgeon-Initiated Bone Health Referral Pathway in Patients Undergoing Lower Extremity Arthroplasty
Osteoporosis, Arthroplasty Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth G Saag, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alendronate in people with Osteoporosis, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All Study Sites--Length of Contracting Procedures (time frame: Length of time Between Clinical Site Recruitment and Contract Execution). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2017.