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NCT00303485 · ClinicalTrials.gov registry record · Phase 4
A Study of Bone Turnover Markers in Post-Menopausal Women With Osteoporosis Treated With Monthly Boniva (Ibandronate)
A Phase 4 study of Post Menopausal Osteoporosis, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 4
- Development phase
- 67
- Enrollment target
- 10
- Study locations
NCT00303485 is a Phase 4 study of Post Menopausal Osteoporosis that has completed, run by Hoffmann-La Roche. The registered enrollment target is 67 participants. The trial reports 10 study locations across 7 states.
The verdict
NCT00303485, a Phase 4 study of Post Menopausal Osteoporosis, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 67 participants
- Enrollment target
- 10
- Study locations
Study Summary
This study will determine the rapidity of suppression of the bone resorption marker sCTX in post-menopausal women with osteoporosis.Other bone turnover markers will also be evaluated. Patients will be randomised to either monthly Boniva 150mg or placebo, in combination with vitamin D and calcium supplementation. The anticipated time on study treatment is approximately 7 months, and the target sample size is \<100 individuals.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Vitamin D and calcium supplementation
- DRUG ibandronate [Bonviva/Boniva]
Study Locations (10)
Other
- - Ponce
- - San Juan
- - San Juan
California
- - Beverly Hills
- - La Jolla
Georgia
- - Augusta
Minnesota
- - Woodbury
New York
- - The Bronx
Pennsylvania
- - Hopwood
Wisconsin
- - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2006-02 |
| Est. Completion | 2007-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00303485
The ClinicalTrials.gov registry entry for NCT00303485 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Post Menopausal Osteoporosis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT00303485 reports 10 study locations spanning 7 distinct geographic areas - top geographies include Other, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT00303485 about?
NCT00303485 is a clinical study titled "A Study of Bone Turnover Markers in Post-Menopausal Women With Osteoporosis Treated With Monthly Boniva (Ibandronate)". This study will determine the rapidity of suppression of the bone resorption marker sCTX in post-menopausal women with osteoporosis.Other bone turnover markers will also be evaluated. Patients will be randomised to either monthly Boniva 150mg or placebo, in combination with vitamin D and calcium sup...
What is the current status of trial NCT00303485?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 67 participants. The study started on 2006-02. Estimated completion is 2007-06.
What conditions does trial NCT00303485 study?
This clinical trial studies the following conditions: Post Menopausal Osteoporosis.
What interventions are being tested in trial NCT00303485?
The interventions under investigation include: Placebo (DRUG), Vitamin D and calcium supplementation (DRUG), ibandronate [Bonviva/Boniva] (DRUG).
Who is sponsoring clinical trial NCT00303485?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00303485 being conducted?
This trial has 10 study locations across California, Georgia, Minnesota, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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