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

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ClinicalTrials.gov Identifier: NCT01279187
Recruitment Status : Terminated (Study was terminated due to patient complications unrelated to study drugs)
First Posted : January 19, 2011
Results First Posted : February 7, 2018
Last Update Posted : February 7, 2018
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Jill Bashutski, University of Michigan

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Implant
Interventions: Drug: Teriparatide
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

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

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.

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


Participant Flow:   Overall Study
    Teriparatide   Control
STARTED   14   13 
COMPLETED   14   13 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

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

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.

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

Total Total of all reporting groups

Baseline Measures
   Teriparatide   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   13   27 
Age 
[Units: Years]
Mean (Full Range)
 54 
 (33 to 71) 
 53.5 
 (33 to 71) 
 53.95 
 (33 to 71) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      9  64.3%      6  46.2%      15  55.6% 
Male      5  35.7%      7  53.8%      12  44.4% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   14   13   27 


  Outcome Measures

1.  Primary:   Bone Formation Rate   [ Time Frame: 10 weeks ]

2.  Secondary:   Bone Turnover (Mineral Apposition Rates)   [ Time Frame: 10 weeks ]

3.  Secondary:   Bone Turnover: Cortical Tissue Area   [ Time Frame: 10 weeks ]

4.  Secondary:   Bone Turnover: Bone Perimeter Length   [ Time Frame: 10 weeks ]

5.  Secondary:   Bone Turnover: Bone Percentages   [ Time Frame: 10 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jill Bashutski
Organization: University of Michigan
e-mail: jillbashutski@gmail.com


Publications:

Responsible Party: Jill Bashutski, University of Michigan
ClinicalTrials.gov Identifier: NCT01279187     History of Changes
Other Study ID Numbers: HUM00042770
First Submitted: January 18, 2011
First Posted: January 19, 2011
Results First Submitted: June 28, 2017
Results First Posted: February 7, 2018
Last Update Posted: February 7, 2018