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NCT03841058 · ClinicalTrials.gov registry record · Phase 2
Abaloparatide vs. Placebo in Post-Menopausal Women and Abaloparatide in Men Receiving Initial Spinal Fusion Surgery
A Phase 2 study of Spinal Fusion, sponsored by Hospital for Special Surgery, New York.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 96
- Enrollment target
- 1
- Study location
NCT03841058 is a Phase 2 study of Spinal Fusion that is actively recruiting participants, run by Hospital for Special Surgery, New York. The registered enrollment target is 96 participants, below the 478-participant average among 19 other Spinal Fusion trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03841058, a Phase 2 study of Spinal Fusion, is actively recruiting participants, sponsored by Hospital for Special Surgery, New York.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 96 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a prospective randomized, double-blinded, placebo-controlled, phase 2, 12-month pilot to study the efficacy of abaloparatide in postmenopausal women needing lumbar spinal fusion surgery. A total of 72 women with low bone mass who are scheduled to undergo spinal fusion surgery will be randomized 2:1 in a blinded fashion to receive either 80 mcg of abaloparatide subcutaneously (SC) every day or an identical-appearing placebo SC for 6 months. As well as a total of 24 men in an open-label design will be enrolled as an extension to this study. The total anticipated enrollment updated to 97. Outcomes include surgical outcomes at one year, pain, and fusion bone mass volume (FBMV) as a marker of bone union at 6 months and 1 year.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Abaloparatide
Study Locations (1)
New York
- Hospital for Special Surgery - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2019-08-14 |
| Est. Completion | 2026-09 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03841058
The ClinicalTrials.gov registry entry for NCT03841058 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 478-participant average among 19 other Spinal Fusion trials with a reported enrollment target (80% lower). The listed sponsor is Hospital for Special Surgery, New York, which has 194 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Spinal Fusion appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03841058 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT03841058 about?
NCT03841058 is a clinical study titled "Abaloparatide vs. Placebo in Post-Menopausal Women and Abaloparatide in Men Receiving Initial Spinal Fusion Surgery". This is a prospective randomized, double-blinded, placebo-controlled, phase 2, 12-month pilot to study the efficacy of abaloparatide in postmenopausal women needing lumbar spinal fusion surgery. A total of 72 women with low bone mass who are scheduled to undergo spinal fusion surgery will be randomi...
What is the current status of trial NCT03841058?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 96 participants. The study started on 2019-08-14. Estimated completion is 2026-09.
What conditions does trial NCT03841058 study?
This clinical trial studies the following conditions: Spinal Fusion.
What interventions are being tested in trial NCT03841058?
The interventions under investigation include: Placebo (DRUG), Abaloparatide (DRUG).
Who is sponsoring clinical trial NCT03841058?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03841058 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.