Impact of Parathyroid Hormone (PTH) on Osseous Cavity

NCT00277706 | Completed Phase 1

• 1 other identifier: 2004-03
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

periodontitis; bone regeneration; Parathyroid Hormone; moderate to advanced periodontitis

Outcome Measures

Primary Outcomes (1)

• The primary objective of this pilot study is to determine the effect of Forteo (PTH) on periodontal regeneration.

Secondary Outcomes (1)

• The secondary objectives are to determine the effect of PTH on parameters associated with periodontal health such as attachment level, radiographic bone density and bone height, and gingival crevicular fluid levels of bone active cytokines.

Study Arms (2)

FORTEO

EXPERIMENTAL

Procedure: Periodontal surgery; Drug: FORTEO; Dietary Supplement: Vitamin D and Calcium

Placebo

PLACEBO COMPARATOR

Procedure: Periodontal surgery; Drug: Placebo; Dietary Supplement: Vitamin D and Calcium

Interventions

Periodontal surgery PROCEDURE

FORTEO; Placebo

FORTEO DRUG

parathyroid hormone; self-administration for 6 weeks

FORTEO

Placebo DRUG

placebo; self administration for 6 weeks

Placebo

Vitamin D and Calcium DIETARY_SUPPLEMENT

PO, QD, for six weeks

FORTEO; Placebo

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• University of Michigan: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Michigan Center for Oral Health Research

Ann Arbor, Michigan, 48106, United States

Location

Related Publications (2)

• Bashutski JD, Eber RM, Kinney JS, Benavides E, Maitra S, Braun TM, Giannobile WV, McCauley LK. The impact of vitamin D status on periodontal surgery outcomes. J Dent Res. 2011 Aug;90(8):1007-12. doi: 10.1177/0022034511407771. Epub 2011 May 9.

  PMID: 21555774 DERIVED

• Bashutski JD, Eber RM, Kinney JS, Benavides E, Maitra S, Braun TM, Giannobile WV, McCauley LK. Teriparatide and osseous regeneration in the oral cavity. N Engl J Med. 2010 Dec 16;363(25):2396-405. doi: 10.1056/NEJMoa1005361. Epub 2010 Oct 16.

  PMID: 20950166 DERIVED

MeSH Terms

Conditions

Bone Diseases, Metabolic; Periodontitis

Interventions

Teriparatide; Vitamin D; Calcium

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors

Study Officials

• Laurie K McCauley, DDS, PhD

  Professor and Chair

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 12, 2006
• First Posted: January 16, 2006
• Study Start: August 1, 2004
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: October 7, 2009

Record last verified: 2009-10

Locations

US (1)