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NCT00431444 · ClinicalTrials.gov registry record · Phase 4
Effects of Zoledronic Acid and Raloxifene on Bone Turnover Markers in Postmenopausal Women With Low Bone Mineral Density
A Phase 4 study of Osteoporosis, sponsored by Novartis.
- Completed
- Registry status
- Phase 4
- Development phase
- 110
- Enrollment target
- 17
- Study locations
NCT00431444: Completed Phase 4 study of Osteoporosis, sponsored by Novartis.
NCT00431444 is a Phase 4 study of Osteoporosis that has completed, run by Novartis. The registered enrollment target is 110 participants, below the 1,545-participant average among 84 other Osteoporosis trials with a reported enrollment target (93% lower). The trial reports 17 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00431444, a Phase 4 study of Osteoporosis, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 110 participants
- Enrollment target
- 17
- Study locations
Study Summary
This study will compare the effects of Zoledronic acid and Raloxifene in reducing bone turnover markers in postmenopausal women with low bone mineral density over 6 months.
Primary Outcome
The primary efficacy variable was the change from baseline in urine NTx (corrected by creatinine). The primary analysis time point was at 6 months of treatment. The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine.
Conditions Studied
Interventions
- DRUG Zoledronic acid
- DRUG Raloxifene
- DRUG Placebo oral pills
- DRUG Placebo intravenous (i.v.) infusion
Study Locations (17)
Florida
- Jacksonville Center for Clinical Research - Jacksonville
- Women's Physicians of Jacksonville - Jacksonville
- Tampa Clinical Research - Tampa
Oregon
- The Portland Clinic - Portland
- Oregon Health and Science University - Portland
Arizona
- Women's Health Research - Phoenix
California
- Associated Pharma Research Center - Buena Park
District of Columbia
- - Washington D.C.
Illinois
- Springfield Clinic - Springfield
Missouri
- Consultants in Women's Health Care - St Louis
Nebraska
- Alegent Health - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2007-01 |
| Est. Completion | 2008-07 |
| Phase | Phase 4 |
What the finished NCT00431444 record still lists
NCT00431444 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 1,545-participant average among 84 other Osteoporosis trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Osteoporosis appearing as the primary indexed condition, and to 4 interventions - of which Zoledronic acid is the first listed.
NCT00431444 lists 17 locations in 14 states (Florida, Oregon, Arizona).
Frequently Asked Questions
What is clinical trial NCT00431444 about?
NCT00431444 is a clinical study titled "Effects of Zoledronic Acid and Raloxifene on Bone Turnover Markers in Postmenopausal Women With Low Bone Mineral Density". This study will compare the effects of Zoledronic acid and Raloxifene in reducing bone turnover markers in postmenopausal women with low bone mineral density over 6 months.
What is the current status of trial NCT00431444?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 110 participants. The study started on 2007-01. Estimated completion is 2008-07.
What conditions does trial NCT00431444 study?
This clinical trial studies the following conditions: Osteoporosis.
What interventions are being tested in trial NCT00431444?
The interventions under investigation include: Zoledronic acid (DRUG), Raloxifene (DRUG), Placebo oral pills (DRUG), Placebo intravenous (i.v.) infusion (DRUG).
Who is sponsoring clinical trial NCT00431444?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00431444 being conducted?
This trial has 17 study locations across Arizona, California, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for 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 NCT00431444's enrollment target sits among peer trials
110 36th of 84 higher than 49 of 84 other Osteoporosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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