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NCT01166958 · ClinicalTrials.gov registry record · Phase 4
Enhancing Osteoporosis Therapy: Can We Open the Anabolic Window?
A Phase 4 study, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 4
- Development phase
- 26
- Enrollment target
NCT01166958 is a Phase 4 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 26 participants.
The verdict
NCT01166958, a Phase 4 study, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 26 participants
- Enrollment target
Study Summary
Current osteoporosis therapies produce a prompt increase in bone mass, followed by only modest or no further subsequent gains. This limitation, known as the "remodeling transient," reflects the "coupling" of bone resorption with formation such that interventions impacting either of these processes lead to compensatory changes of the other. For example, medications which increase bone formation promptly also stimulate bone resorption. Thus, given the need to dramatically increase bone mass in patients with osteoporosis, it is necessary to "uncouple" formation and resorption. The investigators believe this to be possible using currently existing FDA-approved therapeutic agents, by using a novel, sequential approach. This pilot project will obtain preliminary data essential to support future work. In this study, the investigators will begin to explore the use of sequential anabolic treatment with teriparatide followed by antiresorptive therapy with raloxifene. The investigators propose that such sequential treatment will allow opening of the "anabolic window," the brief period of time following initiation of teriparatide therapy in which bone formation exceeds resorption.
Interventions
- DRUG Teriparatide
- DRUG Raloxifene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2010-09 |
| Est. Completion | 2012-11 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01166958
The ClinicalTrials.gov registry entry for NCT01166958 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Teriparatide is the first listed.
NCT01166958 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01166958 about?
NCT01166958 is a clinical study titled "Enhancing Osteoporosis Therapy: Can We Open the Anabolic Window?". Current osteoporosis therapies produce a prompt increase in bone mass, followed by only modest or no further subsequent gains. This limitation, known as the "remodeling transient," reflects the "coupling" of bone resorption with formation such that interventions impacting either of these processes l...
What is the current status of trial NCT01166958?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 26 participants. The study started on 2010-09. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01166958?
The interventions under investigation include: Teriparatide (DRUG), Raloxifene (DRUG).
Who is sponsoring clinical trial NCT01166958?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
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