Phase 4
Completed N=9
Effectiveness of DiscontinuinG bisphosphonatEs Study: R21 Pilot Study
Source: ClinicalTrials.gov NCT02139007 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: All Study Sites--Length of Contracting Procedures — 3.4 Months
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All Study Sites--Length of Contracting Procedures |
3.4 | — |
| PRIMARY All Study Sites--Length of Time to Site IRB Approval |
13.9 | — |
| PRIMARY All Study Sites-Length of Time to 1st Participant Enrolled |
5.0 | — |
| SECONDARY Clinical Fracture Rate |
0; 0 | — |
| SECONDARY Atypical Femoral Fracture |
0; 0 | — |
| SECONDARY Osteonecrosis of the Jaw |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
1.Females 65+
2.3+ years of alendronate (Fosamax/Binosto) use
- Valid social security number
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02139007). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.