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NCT03396315 · ClinicalTrials.gov registry record · Phase 2
Bisphosphonates for Prevention of Post-Denosumab Bone Loss
A Phase 2 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT03396315: Completed Phase 2 study, sponsored by Columbia University.
NCT03396315 is a Phase 2 study that has completed, run by Columbia University. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03396315, a Phase 2 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
The primary goal of the study is to assess the extent to which bisphosphonate therapy will prevent decreases in bone mass that may occur after cessation of denosumab in premenopausal women with idiopathic osteoporosis (IOP) enrolled in AAAN0161 (FD05114) "Denosumab for the prevention of post-teriparatide bone loss in premenopausal women with idiopathic osteoporosis". In addition, the investigator will observe participants for a second year off bisphosphonate therapy to assess duration of response. The hypothesis is that bisphosphonate therapy with alendronate or zoledronic acid, initiated after recovery of bone remodeling activity, will prevent significant bone loss after discontinuing denosumab.
Primary Outcome
Within-group difference (percent change) in BMD at the lumbar spine (L1-4) will be measured by Dual-energy X-ray absorptiometry (DXA) and calculated.
Interventions
- DRUG Zoledronic Acid
- DRUG Alendronate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2018-01-29 |
| Est. Completion | 2023-06-09 |
| Phase | Phase 2 |
What the finished NCT03396315 record still lists
NCT03396315 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Zoledronic Acid is the first listed.
NCT03396315 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03396315 about?
NCT03396315 is a clinical study titled "Bisphosphonates for Prevention of Post-Denosumab Bone Loss". The primary goal of the study is to assess the extent to which bisphosphonate therapy will prevent decreases in bone mass that may occur after cessation of denosumab in premenopausal women with idiopathic osteoporosis (IOP) enrolled in AAAN0161 (FD05114) "Denosumab for the prevention of post-teripar...
What is the current status of trial NCT03396315?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2018-01-29. Estimated completion is 2023-06-09.
What interventions are being tested in trial NCT03396315?
The interventions under investigation include: Zoledronic Acid (DRUG), Alendronate (DRUG).
Who is sponsoring clinical trial NCT03396315?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03396315's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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