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NCT00277706 · ClinicalTrials.gov registry record · Phase 1
Impact of Parathyroid Hormone (PTH) on Osseous Cavity
A Phase 1 study, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT00277706: Completed Phase 1 study, sponsored by University of Michigan.
NCT00277706 is a Phase 1 study that has completed, run by University of Michigan. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00277706, a Phase 1 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
Parathyroid hormone (PTH) has potent bone-building actions and has been approved for the treatment of osteoporosis as FORTEO by Eli Lilly \& Co. Numerous studies have verified its effectiveness in increasing bone mass and potential for PTH to positively impact oral bone. The hypothesis of this study is that patients administered FORTEO along with periodontal (gum) surgery will respond more favorably than patients who receive placebo. There will be 40 subjects enrolled in this study. All subjects will receive surgical treatment. 20 subjects will receive FORTEO and 20 will receive placebo. Subjects will be assigned to study group randomly. Neither the subjects nor the clinicians will know whether the subject is receiving FORTEO or placebo. Patients will undergo routine periodontal treatment procedures including periodontal surgery. Starting from 3 days prior to surgery, all subjects will self-administer FORTEO or placebo for 6 weeks. Subjects will be trained for self-administration, a procedure similar to diabetic injections. Patients will also take Vitamin D and Calcium by mouth during this time. Study outcomes will be measured by blood collection; oral fluid sampling; oral x-ray and spine and hip bone density scan; routine periodontal examinations; and an oral health quality of life questionnaire. Patients of both genders and all ethnicities from age 30-75 years will be included in the study. All ethnicities are eligible for entry into study. No vulnerable populations will be included. Pregnant/breast-feeding women and women of childbearing potential on no contraception will be excluded from the study. Research records will not be linkable to the research subjects. Subjects will be randomly assigned to treatment arms and identified by initials and numbers. Informed consent forms will be used to obtain consent for participation in the study from all subjects prior to enrollment. The Principal Investigator or Co-Investigator will explain the details of study involv
Interventions
- DRUG Placebo
- DIETARY_SUPPLEMENT Vitamin D and Calcium
- DRUG FORTEO
- PROCEDURE Periodontal surgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2004-08 |
| Est. Completion | 2009-07 |
| Phase | Phase 1 |
What the finished NCT00277706 record still lists
NCT00277706 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00277706 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00277706 about?
NCT00277706 is a clinical study titled "Impact of Parathyroid Hormone (PTH) on Osseous Cavity". Parathyroid hormone (PTH) has potent bone-building actions and has been approved for the treatment of osteoporosis as FORTEO by Eli Lilly \& Co. Numerous studies have verified its effectiveness in increasing bone mass and potential for PTH to positively impact oral bone. The hypothesis of this study...
What is the current status of trial NCT00277706?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2004-08. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00277706?
The interventions under investigation include: Placebo (DRUG), Vitamin D and Calcium (DIETARY_SUPPLEMENT), FORTEO (DRUG), Periodontal surgery (PROCEDURE).
Who is sponsoring clinical trial NCT00277706?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00277706's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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