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NCT00172081 · ClinicalTrials.gov registry record · Phase 3
TOP: Recombinant Human Parathyroid Hormone (ALX1-11) on Fracture Incidence in Women With Postmenopausal Osteoporosis
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,532
- Enrollment target
NCT00172081 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 2,532 participants.
The verdict
NCT00172081, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,532 participants
- Enrollment target
Study Summary
This is an 18-month, double-blind, placebo-controlled, Phase III trial with a 12-month interim analysis of the effect of ALX1-11, recombinant human parathyroid hormone (1-84) (rhPTH \[1-84\]), on fracture incidence in women with postmenopausal osteoporosis, the TOP study.
Interventions
- DRUG placebo
- DRUG ALX1-11
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,532 participants |
| Start Date | 2000-04-27 |
| Est. Completion | 2003-11-07 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00172081
The ClinicalTrials.gov registry entry for NCT00172081 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,532 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00172081 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00172081 about?
NCT00172081 is a clinical study titled "TOP: Recombinant Human Parathyroid Hormone (ALX1-11) on Fracture Incidence in Women With Postmenopausal Osteoporosis". This is an 18-month, double-blind, placebo-controlled, Phase III trial with a 12-month interim analysis of the effect of ALX1-11, recombinant human parathyroid hormone (1-84) (rhPTH \[1-84\]), on fracture incidence in women with postmenopausal osteoporosis, the TOP study.
What is the current status of trial NCT00172081?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,532 participants. The study started on 2000-04-27. Estimated completion is 2003-11-07.
What interventions are being tested in trial NCT00172081?
The interventions under investigation include: placebo (DRUG), ALX1-11 (DRUG).
Who is sponsoring clinical trial NCT00172081?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
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