Primary outcomeMedian· 10 weeks
Bone Formation Rate
| Group | Value (mm2/week) | Spread |
|---|---|---|
| Teriparatide | 1.76 | 0.99 |
| Control | 2.22 | 1.67 |
Trial · Interventional
TerminatedPhase 2Results postedRegistry dataThe Impact of Parathyroid Hormone (PTH) on Craniofacial Osseous Regeneration in Bone
NCTNCT01279187 (opens ClinicalTrials.gov in a new tab)Other idHUM00042770
This trial was stopped early.
Reason given at the registry: Study was terminated due to patient complications unrelated to study drugs
Results were posted for this trial.
Overview
- Status
- Terminated
- Phase
- Phase 2
- Enrollment
- 27 participants (actual)
- Sponsor
- University of Michigan · Other
- Design
- Randomized · Quadruple masking
- Countries
1 country
United States
- Start
- Feb 2011
- Primary completion
- Mar 2015
- Completion
- Nov 2015
- First posted
- 19 Jan 2011 (estimated)
- Last update posted
- 7 Feb 2018
- Conditions
- Implant
Timeline
1 trial · 1 stopped early · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201120122013201420152016
- Ph 2Terminated
The Impact of Parathyroid Hormone (PTH) on Craniofacial Osseous Regeneration in Bone
NCT01279187Feb 2011 to Nov 2015
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- TeriparatideDrug
- PlaceboDrug
Arms2
Experimental
Teriparatide
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.
Placebo comparator
Control
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.
Primary outcomes1
Outcomes the sponsor listed as primary.
Bone Formation Rate
Time frame · 10 weeks
Registry 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.
Secondary outcomes(4)
Bone Turnover (Mineral Apposition Rates)
Time frame · 10 weeks
Registry 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 of 4 equally-spaced sites per double label. These measurements will be performed on 20 double fluorochrome labels per bone and the average divided by the time between the midpoints of the two labeling periods. MAR serves as an index of osteoblast activity. Reported for cancellous (Cn), endocortical (Ec) at baseline (pre-drug intervention, listed as "first set") and at the end of drug intervention ("second set"). "First set" refers to baseline information (pre-drug), and "second set" refers to data evaluated at the end of the drug administration phase. Periosteal (Ps) data and Ec.Mar Endocortical MAR "second set" was reviewed but no analyzable labeling was noted and so this data is not reported.
Bone Turnover: Cortical Tissue Area
Time frame · 10 weeks
Registry 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 abbreviation: Ct.T.Ar: Ct Cort(ex)(ical) Tissue Area (2D)b "First set" refers to baseline pre-drug data and "second set" was taken at the end of the drug administration phase.
Bone Turnover: Bone Perimeter Length
Time frame · 10 weeks
Registry 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
Bone Turnover: Bone Percentages
Time frame · 10 weeks
Registry 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: Osteoid surface divided by bone surface. Percentage of cancellous bone perimeter covered with osteoid. Oc.S/BS endocortical: Osteoclastic surface as percent of total bone surface in endocortical bone. OS/BS endocortical: Percentage of endocortical bone perimeter covered with osteoid. Oc.S/BS Periosteal: Osteoclastic surface as percent of total bone surface in periosteal bone. Ob.S/BS Periosteal: Percent periosteal bone perimeter with osteoid and adjacent osteoblasts, identified as plump cells with a single, eccentric nucleus and a pale-staining golgi apparatus. Osteoblast Surface divided by bone surface in periosteal bone. OS/BS Periosteal: Percentage of periosteal bone perimeter covered with osteoid.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(4)
Secondary outcomeMean· 10 weeks
Bone Turnover (Mineral Apposition Rates)
| Group | Value (um/day) | Spread |
|---|---|---|
| Teriparatide | 0.5 | 0.1 |
| Control | 0.3 | 0.2 |
Secondary outcomeMean· 10 weeks
Bone Turnover: Cortical Tissue Area
| Group | Value (mm2/week) | Spread |
|---|---|---|
| Teriparatide | 2.2 | 1.6 |
| Control | 1.8 | 1 |
Secondary outcomeMean· 10 weeks
Bone Turnover: Bone Perimeter Length
| Group | Value (mm) | Spread |
|---|---|---|
| Teriparatide | 20.8 | 11.1 |
| Control | 18.7 | 9.6 |
Secondary outcomeMean· 10 weeks
Bone Turnover: Bone Percentages
| Group | Value (percentage (%)) | Spread |
|---|---|---|
| Teriparatide | 0.34 | 0.42 |
| Control | 0.15 | 0.21 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Teriparatidedemeclocycline 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. Teriparatide: 20ug per day,via subcutaneous injection, for 7 weeks | 0 / 14 | 0 / 14 | 12 / 14 |
| Controldemeclocycline 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. Placebo: 20ug per day, self administered injection, for 7 weeks | 0 / 13 | 0 / 13 | 11 / 13 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies2
Studies that cite this trial.
Studies with results
2 studies on this page
Indexing hint: Animal study · 2005
19 results
Enhancement of experimental fracture-healing by systemic administration of recombinant human parathyroid hormone (PTH 1-34).
Alkhiary et al. 2005The Journal of bone and joint surgery. American volumecited by 228
PMID 15805200DOI 10.2106/jbjs.d.02115PUB-15805200
Full text at the publisher19 results
Indexing hint: Randomized controlled trial · 2001
12 results
Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis.
Neer et al. 2001The New England journal of medicinecited by 3,051
PMID 11346808DOI 10.1056/nejm200105103441904PUB-11346808
Rights unknown12 results
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 30 Years up to 85 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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,
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