Impact of Parathyroid Hormone (PTH) on Osseous Cavity
Status:
Completed
Trial end date:
2009-07-01
Target enrollment:
Participant gender:
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 involvement and give subjects ample
opportunity to ask questions.
It is anticipated that patients on FORTEO will have greater regeneration with periodontal
therapy as compared to control patients.