Expired Study
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Ann Arbor, Michigan 48106


Purpose:

Good bone healing and bone build-up are necessary for the success of dental implants. Research in animals and humans has shown that a drug, called Forteo, can increase bone build-up and bone strength over time. Forteo has been approved by the Food and Drug Administration (FDA) for use in patients with a condition where bone is broken down and weakened, called osteoporosis. The investigators do not know, however, whether Forteo is effective for use in humans for improving bone healing after implant placement, and whether it will have the same bone-building and bone-strengthening effects as for patients with osteoporosis. This research study is being done to learn what effect 7 weeks of treatment with Forteo will have on bone build-up and strengthening of bone for patients receiving implants.


Study summary:

A single center, placebo-controlled, double blind parallel study of teriparatide use in patients requiring dental implant therapy is planned. Subjects who qualify based on the inclusion/exclusion criteria will be randomly placed into one of two treatment groups, teriparatide (20 μg/day) or placebo control. Both patients and investigators will be blinded. Serum and gingival crevicular fluid (GCF) samples, radiographs, and a tetracycline-labelled bone core will constitute the main data gathered for analysis. After implant surgery, patients will return at 2 weeks for post-operative care and then at 14 weeks for an implant impression and again at 16 weeks to receive the final restoration. Twelve months after implant placement, patients will be seen for a follow-up exam and standardized radiograph to ensure proper healing.


Criteria:

Inclusion Criteria: - Age range 30-85 yrs - Sex: male and female (female subjects must be postmenopausal, surgically sterilized or utilizing birth control or abstinence throughout the period of Teriparatide administration) - Subjects must be able and willing to follow study procedures and instructions; - Subjects must have read, understood and signed an informed consent form; - Subjects must have a need for the replacement of at least one tooth in the mandibular premolar/molar region with at least 12 months since the tooth extraction. - Sites must be adaptable for dental implant placement without the necessity for grafting. Exclusion Criteria: - Subjects under 30 years or over 85 years of age, - Female subjects who are pregnant, lactating, or female subjects who are of childbearing potential who are not using contraceptives, - Subjects with metabolic bone diseases such as Paget's disease, hypercalcemia (mild to moderate hypocalcemia is acceptable for entry into the study), moderate to severe vitamin D3 abnormalities (If vitamin D levels are below 16 ng/ml and patient exhibits interest, dietary supplementation will be suggested and levels re-evaluated after 4 weeks and reconsidered for inclusion at that time), any other metabolic bone diseases including osteoporosis, - Subjects with prior radiation therapy, bone metastases or other skeletal malignancy, - Subjects on medications that would affect bone metabolism, - Subjects with growth hormone deficiency, - Subjects with uncontrolled diabetes, sprue, inflammatory bowel disease or other disorders that would affect calcium absorption - Subjects that are heavy smokers (> 1 pack/d), - Subjects with tetracycline sensitivity or allergy, - Subjects on bisphosphonates, - Subjects with any form of kidney disease including kidney stones (urolithiasis and nephrolithiasis), - Subjects with known allergies to tetracycline and/or demeclocycline,


Study is Available At:


Original ID:

HUM00042770


NCT ID:

NCT01279187


Secondary ID:


Study Acronym:


Brief Title:

The Impact of Parathyroid Hormone (PTH) on Craniofacial Osseous Regeneration in Bone


Official Title:

The Impact of Parathyroid Hormone (PTH) on Craniofacial Osseous Regeneration in Bone


Overall Status:

Terminated


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

30 Years


Maximum Age:

85 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Michigan


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

Study was terminated due to patient complica


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

27


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jill Bashutski, DDS, MS
Principal Investigator
Faculty

Study Dates

Start Date:February 2011
Completion Date:November 2015
Completion Type:Actual
Primary Completion Date:March 2015
Primary Completion Type:Actual
Verification Date:January 2018
Last Changed Date:January 31, 2018
First Received Date:January 18, 2011
First Results Date:June 28, 2017

Study Outcomes

Outcome Type:Primary Outcome
Measure:Bone Formation Rate
Time Frame:10 weeks
Safety Issues:False
Description:To determine the impact of PTH on bone quality and bone turnover in the oral cavity. The primary outcome variable will be bone formation rate.
Outcome Type:Secondary Outcome
Measure:Bone Turnover (Mineral Apposition Rates)
Time Frame:10 weeks
Safety Issues:False
Description:Bone turnover was assessed indirectly by bone histomorphometry using the following abbreviations: Mineral Apposition Rate (MAR): Distance between 2 fluorochrome markers that comprise a double label on the surfaces of cancellous bone measured at an average
Outcome Type:Secondary Outcome
Measure:Bone Turnover: Cortical Tissue Area
Time Frame:10 weeks
Safety Issues:False
Description:Bone turnover was assessed indirectly by evaluating cellular parameters of PTH action (i.e. numbers of osteoblasts, osteoclasts, apoptotic osteoblasts). The methods used to obtain the outcomes described below were bone histomorphometry using the following
Outcome Type:Secondary Outcome
Measure:Bone Turnover: Bone Perimeter Length
Time Frame:10 weeks
Safety Issues:False
Description:Bone histomorphometry was used to assess bone perimeter length in mm as follows: Cn.Pm cancellous: Cancellous Bone Perimeter Ec.Pm: endocortical bone perimeter Ps.Pm: Periosteal Periosteal bone perimeter
Outcome Type:Secondary Outcome
Measure:Bone Turnover: Bone Percentages
Time Frame:10 weeks
Safety Issues:False
Description:Oc.S/BS cancellous: Osteoclast suface divided by bone surface. Osteoclastic surface as percent of total bone surface in cancellous bone. Percent cancellous bone perimeter with osteoclasts (large, multinuclear, TRAP positive cells). OS/BS cancellous: Oste

Study Interventions

Intervention Type:Drug
Name:Teriparatide
Description:20ug per day,via subcutaneous injection, for 7 weeks
Arm Name:Teriparatide
Other Name:Forteo
Intervention Type:Drug
Name:Placebo
Description:20ug per day, self administered injection, for 7 weeks
Arm Name:Control
Other Name:carrier

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Control
Description:demeclocycline HCl (150 mg, four times per day for 3d) followed by a 12 day intermission then 3 more days of demeclocycline HCl (150 mg, four times per day). One day after the last demeclocycline dosage, subjects will be instructed to self-administer teriparatide (or placebo) for 7 weeks. Twenty-five days after the last demeclocycline dosage, subjects will begin their second set of tetracycline labels:(250 mg, four times per day) for three days, followed by 12 days off, and then repeat another 3
Study Arm Type:Experimental
Arm Name:Teriparatide
Description:demeclocycline HCl (150 mg, four times per day for 3d) followed by a 12 day intermission then 3 more days of demeclocycline HCl (150 mg, four times per day). One day after the last demeclocycline dosage, subjects will be instructed to self-administer teriparatide (or placebo) for 7 weeks. Twenty-five days after the last demeclocycline dosage, subjects will begin their second set of tetracycline labels:(250 mg, four times per day) for three days, followed by 12 days off, and then repeat another 3

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Michigan
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Eli Lilly and Company

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Chen H, Frankenburg EP, Goldstein SA, McCauley LK. Combination of local and systemic parathyroid hormone enhances bone regeneration. Clin Orthop Relat Res. 2003 Nov;(416):291-302.
PMID:14646773
Reference Type:Reference
Citation:Alkhiary YM, Gerstenfeld LC, Krall E, Westmore M, Sato M, Mitlak BH, Einhorn TA. Enhancement of experimental fracture-healing by systemic administration of recombinant human parathyroid hormone (PTH 1-34). J Bone Joint Surg Am. 2005 Apr;87(4):731-41.
PMID:15805200
Reference Type:Reference
Citation:Neer RM, Arnaud CD, Zanchetta JR, Prince R, Gaich GA, Reginster JY, Hodsman AB, Eriksen EF, Ish-Shalom S, Genant HK, Wang O, Mitlak BH. Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med. 2001 May 10;344(19):1434-41.
PMID:11346808
Reference Type:Reference
Citation:Hanley, D., et al., Pharmacologic mechanisms of therapeutics:Parathyroid Hormone, in Principles of Bone Biology, J. Bilezikian, L. Raisz, and T. Martin, Editors. 2008, Academic Press: San Diego. p. 1661-1695.

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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