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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: Clinical Trial Phase 1 study, sponsored by Genzyme, a Sanofi Company.
NCT00078026 is a Phase 1 study that was terminated before completion, run by Genzyme, a Sanofi Company. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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 |
Why NCT00078026 stopped before completion
NCT00078026 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Apomine is the first listed.
NCT00078026 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00078026's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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