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NCT00130403 · ClinicalTrials.gov registry record · Phase 4
OPTAMISE: Clinical Effectiveness of Teriparatide After Alendronate or Risedronate Therapy in Osteoporotic Postmenopausal Women
A Phase 4 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 4
- Development phase
- 290
- Enrollment target
NCT00130403 is a Phase 4 study that has completed, run by Sanofi. The registered enrollment target is 290 participants.
The verdict
NCT00130403, a Phase 4 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 290 participants
- Enrollment target
Study Summary
To determine how prior therapy with alendronate or risedronate in postmenopausal women with osteoporosis influences the clinical effectiveness of teriparatide; The primary objective of the study is to compare the teriparatide (human, recombinant PTH\[1-34\])-associated change from baseline in a marker of bone formation, N-terminal propeptide of type I collagen (P1NP), between subjects previously treated with risedronate and those previously treated with alendronate.
Interventions
- DRUG risedronate sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 290 participants |
| Start Date | 2004-03 |
| Est. Completion | 2007-03 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00130403
The ClinicalTrials.gov registry entry for NCT00130403 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 290 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which risedronate sodium is the first listed.
NCT00130403 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00130403 about?
NCT00130403 is a clinical study titled "OPTAMISE: Clinical Effectiveness of Teriparatide After Alendronate or Risedronate Therapy in Osteoporotic Postmenopausal Women". To determine how prior therapy with alendronate or risedronate in postmenopausal women with osteoporosis influences the clinical effectiveness of teriparatide; The primary objective of the study is to compare the teriparatide (human, recombinant PTH\[1-34\])-associated change from baseline in a mark...
What is the current status of trial NCT00130403?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 290 participants. The study started on 2004-03. Estimated completion is 2007-03.
What interventions are being tested in trial NCT00130403?
The interventions under investigation include: risedronate sodium (DRUG).
Who is sponsoring clinical trial NCT00130403?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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