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NCT01705587 · ClinicalTrials.gov registry record · Phase 4
Fracture (FX) Improvement With Teriparatide: FiX-IT Study
A Phase 4 study, sponsored by Susan L. Greenspan.
- Completed
- Registry status
- Phase 4
- Development phase
- 13
- Enrollment target
NCT01705587: Completed Phase 4 study, sponsored by Susan L. Greenspan.
NCT01705587 is a Phase 4 study that has completed, run by Susan L. Greenspan. The registered enrollment target is 13 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01705587, a Phase 4 study, has completed, sponsored by Susan L. Greenspan.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 13 participants
- Enrollment target
Study Summary
This open label comparison study examines the hypothesis that teriparatide given immediately following repair of an atypical subtrochanteric or diaphyseal femoral shaft fracture will enhance healing and improve bone mineral density compared to delayed treatment (after six months) with teriparatide or no treatment with teriparatide (patients who refuse therapy or for whom teriparatide is contraindicated). Patients with up-front teriparatide in addition will have greater quality of life measures and less pain compared to those with delayed or no therapy.
Primary Outcome
The radiologic indices of fracture healing included (1) cortical continuity on two of four cortices, (2) persistence of alignment, (3) decreased conspicuity of fracture line, and (4) increased callus formation. For each of these indices, healing was graded on a scale of 1 to 4 with 1 = no change (less than 25%), 2 = minimum healing (25-50%), 3 = moderate healing (50-75%), and 4 = complete healing (greater than 75%). A composite score was calculated by summing the subscale scores for the 4 indice
Interventions
- DRUG teriparatide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2012-12 |
| Est. Completion | 2016-09 |
| Phase | Phase 4 |
What the finished NCT01705587 record still lists
NCT01705587 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which teriparatide is the first listed.
NCT01705587 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01705587 about?
NCT01705587 is a clinical study titled "Fracture (FX) Improvement With Teriparatide: FiX-IT Study". This open label comparison study examines the hypothesis that teriparatide given immediately following repair of an atypical subtrochanteric or diaphyseal femoral shaft fracture will enhance healing and improve bone mineral density compared to delayed treatment (after six months) with teriparatide o...
What is the current status of trial NCT01705587?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 13 participants. The study started on 2012-12. Estimated completion is 2016-09.
What interventions are being tested in trial NCT01705587?
The interventions under investigation include: teriparatide (DRUG).
Who is sponsoring clinical trial NCT01705587?
This trial is sponsored by Susan L. Greenspan, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01705587's enrollment target sits among peer trials
13 1910th of 2000 higher than 88 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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