Post-menopausal OsteoporosisNCT01826656
Bone Healing in Healthy and Post-menopausal Osteoporotic Women
A study testing tooth extraction, CBCT scan and DXA scan in people with Post-menopausal Osteoporosis, run by University College, London at 1 site in United Kingdom.
Trial summary
Both the pathogenesis and the treatment of osteoporosis may potentially interfere at different levels on the multi-stage complex cascade of events involved in bone healing/regeneration. Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-menopausal Osteoporosis
- What is being tested?
- tooth extraction, CBCT scan and DXA scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2014to Nov 2015
- Phase
- Interventional
- 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 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caucasian women, > 50 years old
- women referring to have reached a menopause status, defined as the permanent cessation of the ovulation, since at least 1 year and presenting a diagnosis of osteoporosis based on dual X-rays energy absorptiometry (DXA) measurement of the bone mineral density at the femur neck or lateral spine (t value 2.5 SD or more below the young female adult mean) (TEST GROUP)
- women in menopausal status since at least 1 year and with normal bone mineral density, as assessed by DXA scan (CONTROL GROUP)
- subjects needing a tooth extraction. The tooth to extract should present at least 30% of its attachment level preserved. Wisdom teeth are excluded from this study
- Subjects must have voluntarily signed the informed consent.
Who cannot join
- on hormone replacement therapy (HRT) or taking any other drugs (except Vit D and calcium) for the treatment of osteoporosis (e.g. biphosphonates)
- on chronic treatment (i.e., two weeks or more) with any medication known to affect oral status (e.g., phenytoin, cyclosporine, and non-steroidal anti-inflammatory drugs) within one month from baseline visit.
- affected by systemic diseases recognized to affect bone metabolism (e.g. Cushing's syndrome, Addison's disease, non-controlled diabetes mellitus, leukemia, pernicious anemia, malabsorption syndromes, chronic liver disease, rheumatoid arthritis..)
- on therapy with drugs that can affect bone metabolism (e.g. glucocorticoids, anticonvulsants, anticoagulants, benzodiazepines, cytotoxic drugs, immunosuppressants..)
- affected by any known diseases, infections or recent surgical procedures within 30 days of study initiation.
- knowingly have HIV or Hepatitis
Show all 11Show fewer
- history of local radiation therapy
- affected by limited mental capacity or language skills such that study information cannot be understood, informed consent cannot be obtained, or simple instructions cannot be followed.
- presented an acute endodontic lesion in the test tooth or in the neighbouring areas to the experimental procedure
- smokers
- suffering from a known psychological disorder
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Eastman Clinical Investigation Centre
London, WC1X 8LD
About this study
Official title: A Clinical/Real Time Model of Intramembranous Jawbone Healing in Post-menopausal Osteoporotic and Non-osteoporotic Women. A Pilot Study.
Both the pathogenesis and the treatment of osteoporosis may potentially interfere at different levels on the multi-stage complex cascade of events involved in bone healing/regeneration. To our knowledge no human studies have been performed to clarify the potential effect of osteoporosis on post-extraction alveolar healing. The primary outcome of the study is to compare alveolar bone changes in width and height 3 months after tooth extraction in 10 post-menopausal osteoporotic women and 10 post menopausal non osteoporotic women by the use of cone-beam computer tomography (CBCT) images. The secondary outcomes considered are: clinical changes in the external contour of the ridge and periodontal parameters in the neighbouring teeth after a tooth extraction and 3 months later. In addition the accuracy of panoramic morphometric indexes in detecting osteoporosis will be measured.
Read the detailed description
Despite some contradictory results, there is significant pre-clinical evidence, mainly deriving from fracture studies, of a delay in bone formation together with a decrease in bone mineral density and mechanical resistance in osteoporotic-like conditions. Very few human data are available, mainly deriving from retrospective speculations, but they seem to confirm the existence of a delay in consolidation subsequent to bone fractures, a higher rate of orthopedic complications and a reduction in mechanical strength. Some pre-clinical and clinical studies have also supported a negative effect of osteoporosis on bone graft healing and implant success, but controversial opinions exist.
A useful model to study the influence of osteoporosis on bone healing is the post-extraction socket healing, with consideration of the absence of cartilage formation, the short period needed to heal and its clinical relevance.
The animal studies reported controversial results, but a general reduction and a delay in bone formation with an increase in bone turnover was usually observed in ovariectomized rats. No human studies have clarified the effect of osteoporosis on post-extraction alveolar healing. This pilot study will try to shed light on this topic.
As there are no similar studies in the literature, we estimated that 10 post-menopausal osteoporotic women (test) and 10 healthy pre or post-menopausal women (control) would be a convenient sample to collect enough data for our purpose. This will also allow us to collect information about the variance to power a further study (if needed).
In this study, women who need the extraction of a single tooth due to fracture, destroying caries, periodontitis, endodontic or prosthetic reasons will be included. The tooth should present at least 30% of its periodontal attachment preserved. All the patients will be provided a full-mouth diagnosis of soft and hard tissues, detailed hygiene instructions and the careful removal of plaque and tartar in a highly controlled research environment as part of the project and all the treatment will be free of charge. Subjects of the test group will be recruited among newly diagnosed post-menopausal osteoporotic women attending the Rheumatology clinic at the University College of London Hospital, whilst subjects of the control group will be recruited among healthy women attending the Eastman Dental Institute. Written informed consent will be obtained prior to any clinical evaluation. Differences between test and control groups will be assessed at each time interval using either parametric (if data are normally distributed with approximately equal variances) or non-parametric tests.
- Conditions
- Post-menopausal Osteoporosis
- Being tested
- tooth extraction, CBCT scan, DXA scan, Panoramic radiograph
- Keywords
- intramembranous bone healing, post-menopausal osteoporosis, tooth extraction
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tooth extractionProcedure or surgery
Patients from both groups will follow the extraction of an hopeless tooth
CBCT scanRadiation
A CBCT scan will be performed within 2 days from the tooth extraction at after 3 months (+/-2 days)
DXA scanRadiation
DXA scan will be performed at the hip and lumbar spine in all self-reported non-osteoporotic subjects who hasn't done one within 1 year, to confirm their normal bone mineral density. Osteoporotic subjects already have a DXA scanner.
Panoramic radiographRadiation
As basic standard of care, a panoramic radiograph will be performed to both test and control subjects who haven't done one within the previous year, in order to give them a full-mouth dental diagnosis
| Study group | Role | What they receive |
|---|---|---|
| post-menopausal osteoporotic women | Other | Subjects of test group will follow a tooth extraction and they will perform a CBCT scan within 10 days from the extraction and after 3 months (+/-15 days) Receives: Procedure: tooth extraction; Radiation: CBCT scan; Radiation: DXA scan; Radiation: Panoramic radiograph |
| non-osteoporotic post-menopausal women | Active comparator | Subjects of the control group will follow a tooth extraction and will perform a CBCT scan within 2 days from the extraction and after 3 months (+/- 2 days) Receives: Procedure: tooth extraction; Radiation: CBCT scan; Radiation: DXA scan; Radiation: Panoramic radiograph |
What is being measured
The primary outcome is the main question the study is designed to answer.
alveolar bone width and height alveolar bone changes in width and height
By the use of CBCT scans, alveolar bone changes in width and height will be recorded just after tooth extraction and 3 months later
Measured: within 10 days from tooth extraction and at 3 months (+/- 15 days)
Secondary outcomes (1)
- Clinical changes of soft and hard tissue and of periodontal parameters in the neighbouring teeth; - Accuracy of panoramic morphometric indexes in detecting osteoporosis
- By the use of a probe, periodontal parameters in the neighbouring teeth and relevant clinical changes of the alveolar ridge will be recorded
- On a panoramic radiograph quantitative and qualitative indexes will be calculated and their accuracy in detecting osteoporosis assessed
Measured: after tooth extraction (once the coagulation has been allowed) and at 3 months (+/- 15 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startMay 2014
- Primary completionDec 2014
- Study completionNov 2015
Why it stopped: Unable to recruit suitable patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Post-menopausal OsteoporosisStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikolaos Donos, Professor, Study chair, UCL Eastman Dental Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01826656
- Sponsor's protocol ID
- OsteoporosisTrial
- Status last verified
- Oct 2017
- First submitted
- 26 Mar 2013
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Cortet B. Bone repair in osteoporotic bone: postmenopausal and cortisone-induced osteoporosis. Osteoporos Int. 2011 Jun;22(6):2007-10. doi: 10.1007/s00198-011-1612-3.
PubMed 21523399Shimizu M, Furuya R, Kawawa T, Sasaki T. Bone wound healing after maxillary molar extraction in ovariectomized aged rats: quantitative backscattered electron image analysis. Anat Rec. 2000 May 1;259(1):76-85. doi: 10.1002/(SICI)1097-0185(20000501)259:13.0.CO;2-0.
PubMed 10760746Tanaka S, Shimizu M, Debari K, Furuya R, Kawawa T, Sasaki T. Acute effects of ovariectomy on wound healing of alveolar bone after maxillary molar extraction in aged rats. Anat Rec. 2001 Feb 1;262(2):203-12. doi: 10.1002/1097-0185(20010201)262:23.0.CO;2-#.
PubMed 11169915He YX, Zhang G, Pan XH, Liu Z, Zheng LZ, Chan CW, Lee KM, Cao YP, Li G, Wei L, Hung LK, Leung KS, Qin L. Impaired bone healing pattern in mice with ovariectomy-induced osteoporosis: A drill-hole defect model. Bone. 2011 Jun 1;48(6):1388-400. doi: 10.1016/j.bone.2011.03.720. Epub 2011 Mar 21.
PubMed 21421090Erdogan O, Shafer DM, Taxel P, Freilich MA. A review of the association between osteoporosis and alveolar ridge augmentation. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Dec;104(6):738.e1-13. doi: 10.1016/j.tripleo.2007.04.008. Epub 2007 Jul 26.
PubMed 17656117
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical/Real Time Model of Intramembranous Jawbone Healing in Post-menopausal Osteoporotic and Non-osteoporotic Women. A Pilot Study.
- ClinicalTrials.gov ID
- NCT01826656
- Acronym / sponsor ID
- OsteoporosisTrial
- Conditions
- Post-menopausal Osteoporosis
- Keywords
- intramembranous bone healing, post-menopausal osteoporosis, tooth extraction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit suitable patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Nov 2015
- First posted
- 8 Apr 2013 (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.
Both the pathogenesis and the treatment of osteoporosis may potentially interfere at different levels on the multi-stage complex cascade of events involved in bone healing/regeneration. To our knowledge no human studies have been performed to clarify the potential effect of osteoporosis on post-extraction alveolar healing. The primary outcome of the study is to compare alveolar bone changes in width and height 3 months after tooth extraction in 10 post-menopausal osteoporotic women and 10 post menopausal non osteoporotic women by the use of cone-beam computer tomography (CBCT) images. The secondary outcomes considered are: clinical changes in the external contour of the ridge and periodontal parameters in the neighbouring teeth after a tooth extraction and 3 months later. In addition the accuracy of panoramic morphometric indexes in detecting osteoporosis will be measured.
Detailed description
Despite some contradictory results, there is significant pre-clinical evidence, mainly deriving from fracture studies, of a delay in bone formation together with a decrease in bone mineral density and mechanical resistance in osteoporotic-like conditions. Very few human data are available, mainly deriving from retrospective speculations, but they seem to confirm the existence of a delay in consolidation subsequent to bone fractures, a higher rate of orthopedic complications and a reduction in mechanical strength. Some pre-clinical and clinical studies have also supported a negative effect of osteoporosis on bone graft healing and implant success, but controversial opinions exist.
A useful model to study the influence of osteoporosis on bone healing is the post-extraction socket healing, with consideration of the absence of cartilage formation, the short period needed to heal and its clinical relevance.
The animal studies reported controversial results, but a general reduction and a delay in bone formation with an increase in bone turnover was usually observed in ovariectomized rats. No human studies have clarified the effect of osteoporosis on post-extraction alveolar healing. This pilot study will try to shed light on this topic.
As there are no similar studies in the literature, we estimated that 10 post-menopausal osteoporotic women (test) and 10 healthy pre or post-menopausal women (control) would be a convenient sample to collect enough data for our purpose. This will also allow us to collect information about the variance to power a further study (if needed).
In this study, women who need the extraction of a single tooth due to fracture, destroying caries, periodontitis, endodontic or prosthetic reasons will be included. The tooth should present at least 30% of its periodontal attachment preserved. All the patients will be provided a full-mouth diagnosis of soft and hard tissues, detailed hygiene instructions and the careful removal of plaque and tartar in a highly controlled research environment as part of the project and all the treatment will be free of charge. Subjects of the test group will be recruited among newly diagnosed post-menopausal osteoporotic women attending the Rheumatology clinic at the University College of London Hospital, whilst subjects of the control group will be recruited among healthy women attending the Eastman Dental Institute. Written informed consent will be obtained prior to any clinical evaluation. Differences between test and control groups will be assessed at each time interval using either parametric (if data are normally distributed with approximately equal variances) or non-parametric tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| post-menopausal osteoporotic women | Other | Procedure: tooth extraction, Radiation: CBCT scan, Radiation: DXA scan, Radiation: Panoramic radiographSubjects of test group will follow a tooth extraction and they will perform a CBCT scan within 10 days from the extraction and after 3 months (+/-15 days) |
| non-osteoporotic post-menopausal women | Active comparator | Procedure: tooth extraction, Radiation: CBCT scan, Radiation: DXA scan, Radiation: Panoramic radiographSubjects of the control group will follow a tooth extraction and will perform a CBCT scan within 2 days from the extraction and after 3 months (+/- 2 days) |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Caucasian women, > 50 years old
- women referring to have reached a menopause status, defined as the permanent cessation of the ovulation, since at least 1 year and presenting a diagnosis of osteoporosis based on dual X-rays energy absorptiometry (DXA) measurement of the bone mineral density at the femur neck or lateral spine (t value 2.5 SD or more below the young female adult mean) (TEST GROUP)
- women in menopausal status since at least 1 year and with normal bone mineral density, as assessed by DXA scan (CONTROL GROUP)
- subjects needing a tooth extraction. The tooth to extract should present at least 30% of its attachment level preserved. Wisdom teeth are excluded from this study
- Subjects must have voluntarily signed the informed consent.
Key exclusion criteria (11 listed)
- on hormone replacement therapy (HRT) or taking any other drugs (except Vit D and calcium) for the treatment of osteoporosis (e.g. biphosphonates)
- on chronic treatment (i.e., two weeks or more) with any medication known to affect oral status (e.g., phenytoin, cyclosporine, and non-steroidal anti-inflammatory drugs) within one month from baseline visit.
- affected by systemic diseases recognized to affect bone metabolism (e.g. Cushing's syndrome, Addison's disease, non-controlled diabetes mellitus, leukemia, pernicious anemia, malabsorption syndromes, chronic liver disease, rheumatoid arthritis..)
- on therapy with drugs that can affect bone metabolism (e.g. glucocorticoids, anticonvulsants, anticoagulants, benzodiazepines, cytotoxic drugs, immunosuppressants..)
- affected by any known diseases, infections or recent surgical procedures within 30 days of study initiation.
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 |
|---|---|---|
| tooth extractionPatients from both groups will follow the extraction of an hopeless tooth | Procedure or surgery | non-osteoporotic post-menopausal women, post-menopausal osteoporotic women |
| CBCT scanA CBCT scan will be performed within 2 days from the tooth extraction at after 3 months (+/-2 days) | Radiation | non-osteoporotic post-menopausal women, post-menopausal osteoporotic women |
| DXA scanDXA scan will be performed at the hip and lumbar spine in all self-reported non-osteoporotic subjects who hasn't done one within 1 year, to confirm their normal bone mineral density. Osteoporotic subjects already have a DXA scanner. | Radiation | non-osteoporotic post-menopausal women, post-menopausal osteoporotic women |
| Panoramic radiographAs basic standard of care, a panoramic radiograph will be performed to both test and control subjects who haven't done one within the previous year, in order to give them a full-mouth dental diagnosis | Radiation | non-osteoporotic post-menopausal women, post-menopausal osteoporotic women |
Primary outcome
alveolar bone width and height alveolar bone changes in width and height
Time frame: within 10 days from tooth extraction and at 3 months (+/- 15 days)
By the use of CBCT scans, alveolar bone changes in width and height will be recorded just after tooth extraction and 3 months later
1 secondary outcome
- Clinical changes of soft and hard tissue and of periodontal parameters in the neighbouring teeth; - Accuracy of panoramic morphometric indexes in detecting osteoporosis
Time frame: after tooth extraction (once the coagulation has been allowed) and at 3 months (+/- 15 days)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Background: PubMed 21523399Cortet B. Bone repair in osteoporotic bone: postmenopausal and cortisone-induced osteoporosis. Osteoporos Int. 2011 Jun;22(6):2007-10. doi: 10.1007/s00198-011-1612-3.
- Background: PubMed 10760746Shimizu M, Furuya R, Kawawa T, Sasaki T. Bone wound healing after maxillary molar extraction in ovariectomized aged rats: quantitative backscattered electron image analysis. Anat Rec. 2000 May 1;259(1):76-85. doi: 10.1002/(SICI)1097-0185(20000501)259:13.0.CO;2-0.
- Background: PubMed 11169915Tanaka S, Shimizu M, Debari K, Furuya R, Kawawa T, Sasaki T. Acute effects of ovariectomy on wound healing of alveolar bone after maxillary molar extraction in aged rats. Anat Rec. 2001 Feb 1;262(2):203-12. doi: 10.1002/1097-0185(20010201)262:23.0.CO;2-#.
- Background: PubMed 21421090He YX, Zhang G, Pan XH, Liu Z, Zheng LZ, Chan CW, Lee KM, Cao YP, Li G, Wei L, Hung LK, Leung KS, Qin L. Impaired bone healing pattern in mice with ovariectomy-induced osteoporosis: A drill-hole defect model. Bone. 2011 Jun 1;48(6):1388-400. doi: 10.1016/j.bone.2011.03.720. Epub 2011 Mar 21.
- Background: PubMed 17656117Erdogan O, Shafer DM, Taxel P, Freilich MA. A review of the association between osteoporosis and alveolar ridge augmentation. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Dec;104(6):738.e1-13. doi: 10.1016/j.tripleo.2007.04.008. Epub 2007 Jul 26.
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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.
Nikolaos Donos, Professor study chair
UCL Eastman Dental Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tooth extraction, CBCT scan and DXA scan in people with Post-menopausal Osteoporosis, run by University College, London at 1 site in United Kingdom.
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 5 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: withdrawn, as of the sponsor's last update on 27 Oct 2017. 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 Kingdom. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
alveolar bone width and height alveolar bone changes in width and height (time frame: within 10 days from tooth extraction and at 3 months (+/- 15 days)). 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 NCT01826656, which also lists 5 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 27 Oct 2017.