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NCT00927186 · ClinicalTrials.gov registry record · Phase 4
Effects of Teriparatide or Zoledronic Acid Treatment on Bone in Postmenopausal Osteoporotic Women
A Phase 4 study of Osteoporosis, Postmenopausal, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 69
- Enrollment target
- 12
- Study locations
NCT00927186: Completed Phase 4 study of Osteoporosis, Postmenopausal, sponsored by Eli Lilly and Company.
NCT00927186 is a Phase 4 study of Osteoporosis, Postmenopausal that has completed, run by Eli Lilly and Company. The registered enrollment target is 69 participants, below the 2,728-participant average among 12 other Osteoporosis, Postmenopausal trials with a reported enrollment target (97% lower). The trial reports 12 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00927186, a Phase 4 study of Osteoporosis, Postmenopausal, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 69 participants
- Enrollment target
- 12
- Study locations
Study Summary
The purpose of this study is to investigate how teriparatide or zoledronic acid affects the bone of postmenopausal osteoporotic women after 6 months of treatment as determined by a bone biopsy sample taken from the iliac crest (upper part of the pelvis). After completing 12 months of treatment all participants are eligible to participate in an additional 12-month open label extension.
Primary Outcome
MS/BS in CC is a measure of the proportion of BS on which new mineralized bone is deposited at the time of tetracycline (T) labeling and is calculated as sum of total extent of double label (DL) plus half the extent of single label (SL) divided by BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in the biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under a microscope. DL
Conditions Studied
Interventions
- DRUG Zoledronic Acid
- DRUG Teriparatide
Study Locations (12)
Georgia
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Atlanta
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Gainesville
Colorado
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Lakewood
Maryland
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Bethesda
Michigan
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Detroit
Nebraska
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Omaha
New Mexico
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Albuquerque
New York
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - West Haverstraw
Wisconsin
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2009-07 |
| Est. Completion | 2012-04 |
| Phase | Phase 4 |
What the finished NCT00927186 record still lists
NCT00927186 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 2,728-participant average among 12 other Osteoporosis, Postmenopausal trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Osteoporosis, Postmenopausal appearing as the primary indexed condition, and to 2 interventions - of which Zoledronic Acid is the first listed.
NCT00927186 lists 12 locations in 11 states (Georgia, Colorado, Maryland).
Frequently Asked Questions
What is clinical trial NCT00927186 about?
NCT00927186 is a clinical study titled "Effects of Teriparatide or Zoledronic Acid Treatment on Bone in Postmenopausal Osteoporotic Women". The purpose of this study is to investigate how teriparatide or zoledronic acid affects the bone of postmenopausal osteoporotic women after 6 months of treatment as determined by a bone biopsy sample taken from the iliac crest (upper part of the pelvis). After completing 12 months of treatment all p...
What is the current status of trial NCT00927186?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 69 participants. The study started on 2009-07. Estimated completion is 2012-04.
What conditions does trial NCT00927186 study?
This clinical trial studies the following conditions: Osteoporosis, Postmenopausal.
What interventions are being tested in trial NCT00927186?
The interventions under investigation include: Zoledronic Acid (DRUG), Teriparatide (DRUG).
Who is sponsoring clinical trial NCT00927186?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00927186 being conducted?
This trial has 12 study locations across Colorado, Georgia, Maryland, Michigan, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00927186's enrollment target sits among peer trials
69 8th of 12 higher than 5 of 12 other Osteoporosis, Postmenopausal trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoporosis, Postmenopausal 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.
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