Impact of Parathyroid Hormone (PTH) on Osseous Cavity

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Collaborator: Eli Lilly and Company
• Treatments: Calcium; Hormones; Teriparatide; Vitamin D

Criteria

Inclusion Criteria:

• Age range: 30 to 75 years

• Sex: Male and female

• Female patients must be postmenopausal (for at least 2 years), surgically sterilized or utilizing one of the following methods of birth control throughout the trial - IUD, diaphragm, Depo-Provera, Norplant, oral contraceptive with condom or spermicidal gel/foam with a condom, or abstinence

• Patients must be able and willing to follow study procedures and instructions

• Patients must have read, understood and signed an informed consent form

• Patients must have localized or generalized, advanced periodontal disease (American Dental Association Class 4)

• Patients must present with at least 10 teeth in the functional dentition

• Each patient must have at least one tooth with the following criteria to enter the study:

• Periodontal probing depths of > 6 mm to < 14 mm

• Attachment loss of > 6 mm to < 14 mm

• Bleeding on probing

Exclusion Criteria:

• Patients under 30 years of age

• Female patients who are pregnant (as determined by positive urine pregnancy test at screening) or lactating, or female patients who are of childbearing potential who are not using hormonal, barrier methods of birth control or abstinence.

• Patients who are using hormonal contraceptives must have started the method not fewer than 30 days prior to the screening examination.

• Patients with metabolic bone diseases such as Paget's disease, hypercalcemia, vitamin D3 abnormalities or any other metabolic bone disease including osteoporosis. (If Vitamin D levels are low (> 20 ng/ml - 24 ng/ml), dietary supplementation will be initiated and levels re-evaluated after 4 weeks and reconsidered for inclusion at that time.)

• Patients with prior radiation treatment, bone metastasis or other skeletal malignancy

• Patients on medications that would affect bone metabolism

• Patients with growth hormone deficiency

• Patients with uncontrolled diabetes, sprue, inflammatory bowel disease or other disorders that would affect calcium absorption.

• Patients who are heavy smokers (> 1 pack/day); Patients on bisphosphonates, including Fosamax

• Patients with any form of kidney disease including kidney stones (urolithiasis and nephrolithiasis); and

• Patients on digitalis therapy