The Impact of Parathyroid Hormone (PTH) on Craniofacial Osseous Regeneration in Bone
Condition: Implant
Intervention: Teriparatide; Placebo
Intervention description: 20ug per day,via subcutaneous injection, for 7 weeks; 20ug per day, self administered injection, for 7 weeks
Intervention MeSH terms: Teriparatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 30 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: dental; implant

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.
    

Eligibility 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,