Bone LossPhase 1NCT00277706
Impact of Parathyroid Hormone (PTH) on Osseous Cavity
A Phase 1 study testing Periodontal surgery, FORTEO and Vitamin D and Calcium in people with Bone Loss and Periodontitis, run by University of Michigan at 1 site in United States.
Trial summary
Parathyroid hormone (PTH) has potent bone-building actions and has been approved for the treatment of osteoporosis as FORTEO by Eli Lilly \& Co. Numerous studies have verified its effectiveness in increasing bone mass and potential for PTH to positively impact oral bone. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Bone Loss, Periodontitis
- What is being tested?
- Periodontal surgery, FORTEO and Vitamin D and Calcium
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Jul 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range: 30 to 75 years
- Sex: Male and female
- Female patients must be postmenopausal (for at least 2 years), surgically sterilized or utilizing one of the following methods of birth control throughout the trial - IUD, diaphragm, Depo-Provera, Norplant, oral contraceptive with condom or spermicidal gel/foam with a condom, or abstinence
- Patients must be able and willing to follow study procedures and instructions
- Patients must have read, understood and signed an informed consent form
- Patients must have localized or generalized, advanced periodontal disease (American Dental Association Class 4)
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- Patients must present with at least 10 teeth in the functional dentition
- Each patient must have at least one tooth with the following criteria to enter the study:
- Periodontal probing depths of > 6 mm to < 14 mm
- Attachment loss of > 6 mm to < 14 mm
- Bleeding on probing
Who cannot join
- Patients under 30 years of age
- Female patients who are pregnant (as determined by positive urine pregnancy test at screening) or lactating, or female patients who are of childbearing potential who are not using hormonal, barrier methods of birth control or abstinence.
- Patients who are using hormonal contraceptives must have started the method not fewer than 30 days prior to the screening examination.
- Patients with metabolic bone diseases such as Paget's disease, hypercalcemia, vitamin D3 abnormalities or any other metabolic bone disease including osteoporosis. (If Vitamin D levels are low (> 20 ng/ml - 24 ng/ml), dietary supplementation will be initiated and levels re-evaluated after 4 weeks and reconsidered for inclusion at that time.)
- Patients with prior radiation treatment, bone metastasis or other skeletal malignancy
- Patients on medications that would affect bone metabolism
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- Patients with growth hormone deficiency
- Patients with uncontrolled diabetes, sprue, inflammatory bowel disease or other disorders that would affect calcium absorption.
- Patients who are heavy smokers (> 1 pack/day); Patients on bisphosphonates, including Fosamax
- Patients with any form of kidney disease including kidney stones (urolithiasis and nephrolithiasis); and
- Patients on digitalis therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan Center for Oral Health Research
Ann Arbor, Michigan, 48106
About this study
Official title: Impact of Parathyroid Hormone (1-34) on Osseous Regeneration in the Oral Cavity
Parathyroid hormone (PTH) has potent bone-building actions and has been approved for the treatment of osteoporosis as FORTEO by Eli Lilly \& Co. Numerous studies have verified its effectiveness in increasing bone mass and potential for PTH to positively impact oral bone. The hypothesis of this study is that patients administered FORTEO along with periodontal (gum) surgery will respond more favorably than patients who receive placebo.
There will be 40 subjects enrolled in this study. All subjects will receive surgical treatment. 20 subjects will receive FORTEO and 20 will receive placebo. Subjects will be assigned to study group randomly. Neither the subjects nor the clinicians will know whether the subject is receiving FORTEO or placebo.
Read more
Patients will undergo routine periodontal treatment procedures including periodontal surgery. Starting from 3 days prior to surgery, all subjects will self-administer FORTEO or placebo for 6 weeks. Subjects will be trained for self-administration, a procedure similar to diabetic injections. Patients will also take Vitamin D and Calcium by mouth during this time. Study outcomes will be measured by blood collection; oral fluid sampling; oral x-ray and spine and hip bone density scan; routine periodontal examinations; and an oral health quality of life questionnaire.
Patients of both genders and all ethnicities from age 30-75 years will be included in the study. All ethnicities are eligible for entry into study. No vulnerable populations will be included. Pregnant/breast-feeding women and women of childbearing potential on no contraception will be excluded from the study. Research records will not be linkable to the research subjects. Subjects will be randomly assigned to treatment arms and identified by initials and numbers. Informed consent forms will be used to obtain consent for participation in the study from all subjects prior to enrollment. The Principal Investigator or Co-Investigator will explain the details of study involvement and give subjects ample opportunity to ask questions.
It is anticipated that patients on FORTEO will have greater regeneration with periodontal therapy as compared to control patients.
Read the detailed description
Parathyroid hormone is an endogenous hormone with potent anabolic and catabolic actions in bone. It has recently been approved for the treatment of osteoporosis and is marketed as FORTEO by Eli Lilly and Company. Numerous studies in humans have validated its use to increase bone mineral density and prevent fractures. Interest has also surfaced in its potential application in the treatment of non-osteoporotic fractures and several animal studies have supported this local application. Little is known regarding its use in treating conditions of the oral cavity, but animal studies suggest that bones of the oral cavity are responsive to the anabolic actions of PTH. Furthermore, a recent study indicated that in a canine model, PTH was effective at reversing periodontal bone loss. Studies from our laboratory indicate that patients with hyperparathyroidism (HPT) do not have an increase in periodontal disease as measured by attachment levels. In fact, in our patient population there was an increase in osseous activity in patients with HPT in the form of tori and exostoses (bony protuberances in the oral cavity). This suggests that increased circulating levels of PTH do not adversely impact the oral cavity. Furthermore, in a wound healing animal model of bone regeneration, we found that regenerating intramembranous bone was more responsive to anabolic actions of PTH than endogenous bone of the vertebrae. These studies highlight the potential for PTH to positively impact osseous healing in the oral cavity in response to periodontal therapy.
The study will be double blinded, and patients will be randomized into one of two treatment groups (FORTEO or placebo once/daily). Patients will self-administer drug on a QD schedule, and take Vitamin D and Calcium, PO, QD, for six weeks. Drug administration will begin three days prior to periodontal surgery. Subjects will be followed at post-op, week 3, week 6, month 3, month 6, month 9, and month 12 visits. Clinical effects will be measured by serum collection, gingival crevicular fluid (GCF) sampling, standard dental radiographs, oral exam including perio probing, oral health quality of life questionnaire, and DEXA scans.
- Conditions
- Bone Loss, Periodontitis
- Being tested
- Periodontal surgery, FORTEO, Placebo, Vitamin D and Calcium
- Keywords
- periodontitis, bone regeneration, Parathyroid Hormone, moderate to advanced periodontitis
- Medical subject headings
- Bone Diseases, Metabolic, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal surgeryProcedure or surgery
FORTEODrug
parathyroid hormone; self-administration for 6 weeks
PlaceboDrug
placebo; self administration for 6 weeks
Vitamin D and CalciumDietary supplement
PO, QD, for six weeks
| Study group | Role | What they receive |
|---|---|---|
| FORTEO | Experimental | Not described Receives: Procedure: Periodontal surgery; Drug: FORTEO; Dietary Supplement: Vitamin D and Calcium |
| Placebo | Placebo comparator | Not described Receives: Procedure: Periodontal surgery; Drug: Placebo; Dietary Supplement: Vitamin D and Calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this pilot study is to determine the effect of Forteo (PTH) on periodontal regeneration.
Secondary outcomes (1)
The secondary objectives are to determine the effect of PTH on parameters associated with periodontal health such as attachment level, radiographic bone density and bone height, and gingival crevicular fluid levels of bone active cytokines.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2006 (estimated)
- Study startAug 2004
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bone LossStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Investigators
- Laurie K McCauley, DDS, PhD, Principal investigator, Professor and Chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00277706
- Sponsor's protocol ID
- 2004-03
- Status last verified
- Oct 2009
- First submitted
- 12 Jan 2006
- Last updated
- 7 Oct 2009
- Results posted
- No
Publications
Bashutski JD, Eber RM, Kinney JS, Benavides E, Maitra S, Braun TM, Giannobile WV, McCauley LK. The impact of vitamin D status on periodontal surgery outcomes. J Dent Res. 2011 Aug;90(8):1007-12. doi: 10.1177/0022034511407771. Epub 2011 May 9.
PubMed 21555774Bashutski JD, Eber RM, Kinney JS, Benavides E, Maitra S, Braun TM, Giannobile WV, McCauley LK. Teriparatide and osseous regeneration in the oral cavity. N Engl J Med. 2010 Dec 16;363(25):2396-405. doi: 10.1056/NEJMoa1005361. Epub 2010 Oct 16.
PubMed 20950166
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Parathyroid Hormone (1-34) on Osseous Regeneration in the Oral Cavity
- ClinicalTrials.gov ID
- NCT00277706
- Acronym / sponsor ID
- 2004-03
- Conditions
- Bone Loss, Periodontitis
- Keywords
- periodontitis, bone regeneration, Parathyroid Hormone, moderate to advanced periodontitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Aug 2004
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 16 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Parathyroid hormone (PTH) has potent bone-building actions and has been approved for the treatment of osteoporosis as FORTEO by Eli Lilly \& Co. Numerous studies have verified its effectiveness in increasing bone mass and potential for PTH to positively impact oral bone. The hypothesis of this study is that patients administered FORTEO along with periodontal (gum) surgery will respond more favorably than patients who receive placebo.
There will be 40 subjects enrolled in this study. All subjects will receive surgical treatment. 20 subjects will receive FORTEO and 20 will receive placebo. Subjects will be assigned to study group randomly. Neither the subjects nor the clinicians will know whether the subject is receiving FORTEO or placebo.
Patients will undergo routine periodontal treatment procedures including periodontal surgery. Starting from 3 days prior to surgery, all subjects will self-administer FORTEO or placebo for 6 weeks. Subjects will be trained for self-administration, a procedure similar to diabetic injections. Patients will also take Vitamin D and Calcium by mouth during this time. Study outcomes will be measured by blood collection; oral fluid sampling; oral x-ray and spine and hip bone density scan; routine periodontal examinations; and an oral health quality of life questionnaire.
Patients of both genders and all ethnicities from age 30-75 years will be included in the study. All ethnicities are eligible for entry into study. No vulnerable populations will be included. Pregnant/breast-feeding women and women of childbearing potential on no contraception will be excluded from the study. Research records will not be linkable to the research subjects. Subjects will be randomly assigned to treatment arms and identified by initials and numbers. Informed consent forms will be used to obtain consent for participation in the study from all subjects prior to enrollment. The Principal Investigator or Co-Investigator will explain the details of study involvement and give subjects ample opportunity to ask questions.
It is anticipated that patients on FORTEO will have greater regeneration with periodontal therapy as compared to control patients.
Detailed description
Parathyroid hormone is an endogenous hormone with potent anabolic and catabolic actions in bone. It has recently been approved for the treatment of osteoporosis and is marketed as FORTEO by Eli Lilly and Company. Numerous studies in humans have validated its use to increase bone mineral density and prevent fractures. Interest has also surfaced in its potential application in the treatment of non-osteoporotic fractures and several animal studies have supported this local application. Little is known regarding its use in treating conditions of the oral cavity, but animal studies suggest that bones of the oral cavity are responsive to the anabolic actions of PTH. Furthermore, a recent study indicated that in a canine model, PTH was effective at reversing periodontal bone loss. Studies from our laboratory indicate that patients with hyperparathyroidism (HPT) do not have an increase in periodontal disease as measured by attachment levels. In fact, in our patient population there was an increase in osseous activity in patients with HPT in the form of tori and exostoses (bony protuberances in the oral cavity). This suggests that increased circulating levels of PTH do not adversely impact the oral cavity. Furthermore, in a wound healing animal model of bone regeneration, we found that regenerating intramembranous bone was more responsive to anabolic actions of PTH than endogenous bone of the vertebrae. These studies highlight the potential for PTH to positively impact osseous healing in the oral cavity in response to periodontal therapy.
The study will be double blinded, and patients will be randomized into one of two treatment groups (FORTEO or placebo once/daily). Patients will self-administer drug on a QD schedule, and take Vitamin D and Calcium, PO, QD, for six weeks. Drug administration will begin three days prior to periodontal surgery. Subjects will be followed at post-op, week 3, week 6, month 3, month 6, month 9, and month 12 visits. Clinical effects will be measured by serum collection, gingival crevicular fluid (GCF) sampling, standard dental radiographs, oral exam including perio probing, oral health quality of life questionnaire, and DEXA scans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FORTEO | Experimental | Procedure: Periodontal surgery, Drug: FORTEO, Dietary Supplement: Vitamin D and Calcium |
| Placebo | Placebo comparator | Procedure: Periodontal surgery, Drug: Placebo, Dietary Supplement: Vitamin D and Calcium |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age range: 30 to 75 years
- Sex: Male and female
- Female patients must be postmenopausal (for at least 2 years), surgically sterilized or utilizing one of the following methods of birth control throughout the trial - IUD, diaphragm, Depo-Provera, Norplant, oral contraceptive with condom or spermicidal gel/foam with a condom, or abstinence
- Patients must be able and willing to follow study procedures and instructions
- Patients must have read, understood and signed an informed consent form
Key exclusion criteria (11 listed)
- Patients under 30 years of age
- Female patients who are pregnant (as determined by positive urine pregnancy test at screening) or lactating, or female patients who are of childbearing potential who are not using hormonal, barrier methods of birth control or abstinence.
- Patients who are using hormonal contraceptives must have started the method not fewer than 30 days prior to the screening examination.
- Patients with metabolic bone diseases such as Paget's disease, hypercalcemia, vitamin D3 abnormalities or any other metabolic bone disease including osteoporosis. (If Vitamin D levels are low (> 20 ng/ml - 24 ng/ml), dietary supplementation will be initiated and levels re-evaluated after 4 weeks and reconsidered for inclusion at that time.)
- Patients with prior radiation treatment, bone metastasis or other skeletal malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periodontal surgery | Procedure or surgery | FORTEO, Placebo |
| FORTEOparathyroid hormone; self-administration for 6 weeks | Drug | FORTEO |
| Placeboplacebo; self administration for 6 weeks | Drug | Placebo |
| Vitamin D and CalciumPO, QD, for six weeks | Dietary supplement | FORTEO, Placebo |
Primary outcome
The primary objective of this pilot study is to determine the effect of Forteo (PTH) on periodontal regeneration.
1 secondary outcome
The secondary objectives are to determine the effect of PTH on parameters associated with periodontal health such as attachment level, radiographic bone density and bone height, and gingival crevicular fluid levels of bone active cytokines.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2009.
- Derived from this study: PubMed 21555774Bashutski JD, Eber RM, Kinney JS, Benavides E, Maitra S, Braun TM, Giannobile WV, McCauley LK. The impact of vitamin D status on periodontal surgery outcomes. J Dent Res. 2011 Aug;90(8):1007-12. doi: 10.1177/0022034511407771. Epub 2011 May 9.
- Derived from this study: PubMed 20950166Bashutski JD, Eber RM, Kinney JS, Benavides E, Maitra S, Braun TM, Giannobile WV, McCauley LK. Teriparatide and osseous regeneration in the oral cavity. N Engl J Med. 2010 Dec 16;363(25):2396-405. doi: 10.1056/NEJMoa1005361. Epub 2010 Oct 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurie K McCauley, DDS, PhD principal investigator
Professor and Chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Periodontal surgery, FORTEO and Vitamin D and Calcium in people with Bone Loss and Periodontitis, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective of this pilot study is to determine the effect of Forteo (PTH) on periodontal regeneration.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00277706, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2009.