Trial · Interventional

CompletedPhase 1Registry data

Impact of Parathyroid Hormone (PTH) on Osseous Cavity

NCTNCT00277706Other id2004-03

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1
Enrollment: 40 participants (estimated)
Sponsor: University of Michigan · Other
Design: Randomized · Double masking
Countries: 1 country
United States
Start: Aug 2004
Primary completion: Jul 2009
Completion: Jul 2009
First posted: 16 Jan 2006 (estimated)
Last update posted: 7 Oct 2009 (estimated)
Conditions: Bone Loss · Periodontitis

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2004200520062007200820092010

Ph 1
Impact of Parathyroid Hormone (PTH) on Osseous Cavity
NCT00277706
Aug 2004 to Jul 2009

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Periodontal surgeryProcedure
FORTEODrug
PlaceboDrug
Vitamin D and CalciumDietary supplement

Arms2

Experimental
FORTEO
Placebo comparator
Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2010

5 results

Teriparatide and osseous regeneration in the oral cavity.

Bashutski et al. 2010The New England journal of medicinecited by 192

PMID 20950166PMC5695223DOI 10.1056/nejmoa1005361PUB-20950166

Rights unknown5 results

Source link See results (5)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedBashutski 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

Eligibility

Who could join, as posted.

Sex: All
Age: from 30 Years up to 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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