Status:
COMPLETED
Impact of Parathyroid Hormone (PTH) on Osseous Cavity
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Bone Loss
Periodontitis
Eligibility:
All Genders
30-75 years
Phase:
PHASE1
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 inc...
Detailed Description
Parathyroid hormone is an endogenous hormone with potent anabolic and catabolic actions in bone. It has recently been approved for the treatment of osteoporosis and is marketed as FORTEO by Eli Lilly ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00277706
Start Date
August 1 2004
End Date
July 1 2009
Last Update
October 7 2009
Active Locations (1)
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1
Michigan Center for Oral Health Research
Ann Arbor, Michigan, United States, 48106