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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: Recruiting Phase 2 study of Spinal Fusion, sponsored by Hospital for Special Surgery, New York.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
CT assessment of fusion mass using a qualitative five-point scale to assess fusion quality (1 = unfused, 2 = partial unilateral fusion, 3 = partial bilateral fusion, 4 = complete unilateral fusion, 5 = complete bilateral fusion)
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 |
What NCT03841058 shows while recruiting
NCT03841058 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 478-participant average among 19 other Spinal Fusion trials with a reported enrollment target (80% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Spinal Fusion
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03841058's enrollment target sits among peer trials
96 11th of 19 higher than 9 of 19 other Spinal Fusion trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Spinal Fusion 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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