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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 is a Phase 2 study that has completed, run by Columbia University. The registered enrollment target is 24 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03396315
The ClinicalTrials.gov registry entry for NCT03396315 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Zoledronic Acid is the first listed.
NCT03396315 reports 0 study locations.
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.
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