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NCT00078026 · ClinicalTrials.gov registry record · Phase 1
An Investigation Into the Short Term Effect of APOMINE in Patients With Osteoporosis or Low Bone Mass
A Phase 1 study, sponsored by Genzyme, a Sanofi Company.
- Terminated
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT00078026 is a Phase 1 study that was terminated before completion, run by Genzyme, a Sanofi Company. The registered enrollment target is 60 participants.
The verdict
NCT00078026, a Phase 1 study, was terminated before completion, sponsored by Genzyme, a Sanofi Company.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
Osteoporosis affects millions of postmenopausal women in the USA. The current approved treatments are all drugs that prevent bone loss and possibly result in small gains in bone mass. Another possible treatment consists of drugs that increase bone formation. There are currently two drugs that stimulate bone formation, sodium fluoride and human parathyroid hormone (hPTH). Neither of these two drugs has been approved by the FDA. APOMINE has shown significant bone formation in animal studies. In this study we plan to test whether APOMINE is able to stimulate new bone formation in women with osteoporosis or low bone mass.
Interventions
- DRUG Apomine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2003-08 |
| Est. Completion | 2004-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00078026
The ClinicalTrials.gov registry entry for NCT00078026 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Apomine is the first listed.
NCT00078026 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00078026 about?
NCT00078026 is a clinical study titled "An Investigation Into the Short Term Effect of APOMINE in Patients With Osteoporosis or Low Bone Mass". Osteoporosis affects millions of postmenopausal women in the USA. The current approved treatments are all drugs that prevent bone loss and possibly result in small gains in bone mass. Another possible treatment consists of drugs that increase bone formation. There are currently two drugs that stimul...
What is the current status of trial NCT00078026?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2003-08. Estimated completion is 2004-12.
What interventions are being tested in trial NCT00078026?
The interventions under investigation include: Apomine (DRUG).
Who is sponsoring clinical trial NCT00078026?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
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