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

NCT01279187 | Terminated Phase 2 Results

• 1 other identifier: HUM00042770
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Implant

Keywords

dental; implant

Outcome Measures

Primary Outcomes (1)

• Bone Formation Rate

  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.

  10 weeks

Secondary Outcomes (4)

• Bone Turnover (Mineral Apposition Rates)

  10 weeks

• Bone Turnover: Cortical Tissue Area

  10 weeks

• Bone Turnover: Bone Perimeter Length

  10 weeks

• Bone Turnover: Bone Percentages

  10 weeks

Study Arms (2)

Teriparatide

EXPERIMENTAL

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 days of tetracycline HCl (250 mg, four times per day). On day of the last teriparatide (or placebo) injection, subjects will present for bone core removal and dental implant placement.

Drug: Teriparatide

Control

PLACEBO COMPARATOR

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 days of tetracycline HCl (250 mg, four times per day). On day of the last teriparatide (or placebo) injection, subjects will present for bone core removal and dental implant placement.

Drug: Placebo

Interventions

Teriparatide DRUG

20ug per day,via subcutaneous injection, for 7 weeks

Also known as: Forteo

Teriparatide

Placebo DRUG

20ug per day, self administered injection, for 7 weeks

Also known as: carrier

Control

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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,

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 (4)

• 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.

  BACKGROUND

• 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. doi: 10.1056/NEJM200105103441904.

  PMID: 11346808 BACKGROUND

• 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. doi: 10.2106/JBJS.D.02115.

  PMID: 15805200 BACKGROUND

• 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. doi: 10.1097/01.blo.0000079443.64912.18.

  PMID: 14646773 BACKGROUND

MeSH Terms

Interventions

Teriparatide; Carrier State

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Epidemiologic Methods; Public Health; Environment and Public Health

Results Point of Contact

• Title: Jill Bashutski
• Organization: University of Michigan

jillbashutski@gmail.com

Study Officials

• Jill Bashutski, DDS, MS

  Faculty

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: January 18, 2011
• First Posted: January 19, 2011
• Study Start: February 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 7, 2018
• Results First Posted: February 7, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)