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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 Postmenopausal Osteoporosis, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 4
- Development phase
- 67
- Enrollment target
- 10
- Study locations
NCT00303485: Completed Phase 4 study of Postmenopausal Osteoporosis, sponsored by Hoffmann-La Roche.
NCT00303485 is a Phase 4 study of Postmenopausal Osteoporosis that has completed, run by Hoffmann-La Roche. The registered enrollment target is 67 participants, below the 516-participant average among 14 other Postmenopausal Osteoporosis trials with a reported enrollment target (87% lower). The trial reports 10 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00303485, a Phase 4 study of Postmenopausal 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.
Primary Outcome
Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body. It is measured in units of nanograms (ng) per milliliter (mL). The relative change in sCTX was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (sCTX time point- sCTX Baseline) / (sCTX Baseline
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 |
What the finished NCT00303485 record still lists
NCT00303485 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 516-participant average among 14 other Postmenopausal Osteoporosis trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Postmenopausal Osteoporosis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT00303485 lists 10 locations in 7 states (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: Postmenopausal 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.
Learn More About Clinical Trials
Similar trials for Postmenopausal Osteoporosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00303485's enrollment target sits among peer trials
67 14th of 14 higher than 1 of 14 other Postmenopausal Osteoporosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postmenopausal Osteoporosis 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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