Impact of Parathyroid Hormone (PTH) on Osseous Cavity

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.

Conditions

• Bone Loss
• Periodontitis

Interventions

PROCEDURE

Periodontal surgery

DRUG

FORTEO

parathyroid hormone; self-administration for 6 weeks

DRUG

Placebo

placebo; self administration for 6 weeks

DIETARY_SUPPLEMENT

Vitamin D and Calcium

PO, QD, for six weeks

Sponsors & Collaborators

• Eli Lilly and Company

  collaborator INDUSTRY

• University of Michigan

  lead OTHER

Principal Investigators

• Laurie K McCauley, DDS, PhD · Professor and Chair

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-08-31

Primary Completion

2009-07-31

Completion

2009-07-31

Countries

• United States

Study Locations