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Dental Panoramic Radiographs to Screen for Post-menopausal Osteoporosis (OsteoPano)

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ClinicalTrials.gov Identifier: NCT03304743
Recruitment Status : Not yet recruiting
First Posted : October 9, 2017
Last Update Posted : January 30, 2018
Sponsor:
Collaborator:
Queen Mary University of London
Information provided by (Responsible Party):
Dr Elena Calciolari, University of Parma

Brief Summary:

Osteoporosis is a common disease that makes the bones fragile and easy to break. Osteoporotic fractures are a serious health problem resulting in pain, reduced mobility, increasing degree of dependence and sometimes death.

Osteoporosis is currently diagnosed by measuring bone density at the hip/spine through an exam called DXA. Although all post-menopausal women are at higher risk, currently Italian national guidelines do not recommend population-screening programs. This leads to several cases not being identified before a fracture occurs.

Since dental panoramic radiographs (OPGs) are common procedures during dental check-ups or before dental treatments, it would be of great value if dentists could use them to identify people with unknown osteoporosis and early refer them to a specialist before they fracture.

This study aims to test if it is meaningful to use OPGs to screen for post-menopausal osteoporosis. In particular, it will inform on how many undiagnosed osteoporotic women attend a Dental Hospital, how willing they are to have a DXA scan after a dental appointment and how precise the OPGs are as screening tools.

124 post-menopausal women will be recruited, which will undergo an OPG and a DXA scan to check their bone density.


Condition or disease Intervention/treatment Phase
Osteoporosis, Postmenopausal Diagnostic Test: Dental panoramic radiograph Diagnostic Test: DXA Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Two examiners blinded to the DXA results will independently measure the panoramic indices on the OPGs.
Primary Purpose: Other
Official Title: Dental Panoramic Radiographs to Screen for Post-menopausal Osteoporosis
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: X-Rays

Arm Intervention/treatment
Experimental: Post-menopausal women Diagnostic Test: Dental panoramic radiograph

If not performed within the previous 6 months at the Centre of Dentistry, an OPG will be performed during enrolment visit.

OPGs are routine low-dose x-rays that are often performed during dental check-ups, follow-ups or before dental treatments (e.g. extractions, implant placement, etc.), as they allow the evaluation of both bone and dental structures of both jaws, the sinus and temporo-mandibular joints.


Diagnostic Test: DXA

On Visit 2, a DXA scan of the hip and lumbar spine will be performed, with the Hologic QDR-4500 Acclaim densitometer owned by the University of Parma and located at the "Centro Osteoporosi e malattie metaboliche scheletriche", if not already available from the previous 6 months.

DXA is a low-dose exam that allows the measurement of bone mineral density in relation to a T- score, and is considered the gold-standard for the diagnosis of osteoporosis.

Patients will be classified into healthy (T score -1), osteopenic (T score between -1 and -2.5) and osteoporotic (T score-2.5).





Primary Outcome Measures :
  1. sensitivity and specificity of Klemetti Index [ Time Frame: At study completion (end of visit 2), so within 6 months from enrolment (visit 1) ]
    To assess the sensitivity and specificity of Klemetti Index (KI) to screen for osteoporosis in postmenopausal women attending the Centre of Dentistry at the University of Parma


Secondary Outcome Measures :
  1. sensitivity and specificity of mandibular cortical width [ Time Frame: At study completion (end of visit 2), so within 6 months from enrolment (visit 1) ]
    To assess the sensitivity and specificity of mandibular cortical width (MCW) to screen for osteoporosis in postmenopausal women

  2. sensitivity and specificity of panoramic mandibular index [ Time Frame: At study completion (end of visit 2), so within 6 months from enrolment (visit 1) ]
    To assess the sensitivity and specificity of panoramic mandibular index (PMI) to screen for osteoporosis in postmenopausal women

  3. Precision and reproducibility of Klemetti index [ Time Frame: At study completion (end of visit 2), so within 6 months from enrolment (visit 1) ]
    Two blind examiners will calculate the index twice (within at least one week from the first evaluation) and intra and inter examiner reproducibility will be assessed through Kappa statistics

  4. Number of undiagnosed osteoporotic women [ Time Frame: during the 9 months of recruitment ]
    To record the number of undiagnosed post-menopausal osteoporotic women attending a University Dental Hospital (Centro Universitario di Odontoiatria)

  5. number of osteoporotic women requiring treatment [ Time Frame: during the 9 months of recruitment ]
    To record the number of osteoporotic women identified as osteoporotic as part of the study that would require pharmacological treatment (based on the Italian modified version of FRAX "DeFRA", and on the Consultant Rheumatologist's advice)

  6. % of post-menopausal women willing to be screened for osteoporosis after a dental appointment [ Time Frame: during the 9 months of recruitment ]
    This will be calculated as the percentage of post-menopausal women meeting the inclusion/exclusion criteria and willing to be screened for osteoporosis after a dental appointment (and therefore enrolled) out of all the patients approached.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women in menopause
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ≥ 65 years old
  • In self-reported menopause, defined as the permanent cessation of ovulation, for at least one year (Soules et al., 2001).

Exclusion Criteria:

  • Affected by systemic diseases (with the exception of osteoporosis) recognized to severely affect bone metabolism (e.g. Cushing's syndrome, Addison's disease, diabetes mellitus type 1, leukaemia, pernicious anaemia, malabsorption syndromes, chronic liver disease, rheumatoid arthritis).
  • Knowingly affected by HIV or viral hepatitis.
  • History of local radiation therapy in the last five years.
  • 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.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality which may increase the risk associated with trial participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03304743


Contacts
Contact: Elena Calciolari, DDS, MS, PhD +39 0521906700 e.calciolari@qmul.ac.uk
Contact: Federico Rivara, DDS, MS +39 0521906700 federivara@gmail.com

Locations
Italy
Centro Universitario di Odontoiatria Recruiting
Parma, Italy
Contact: Elena Calciolari, DDS, MS, PhD    +39 0521906700    e.calciolari@qmul.ac.uk   
Contact: Federico Rivara, DDS, MS    +39 0521906700    federivara@gmail.com   
Sponsors and Collaborators
University of Parma
Queen Mary University of London
Investigators
Principal Investigator: Elena Calciolari, DDS, MS, PHD University of Parma and Queen Mary University of London

Publications:
Responsible Party: Dr Elena Calciolari, Dr, MS, Phd, Clinical Research Fellow, University of Parma
ClinicalTrials.gov Identifier: NCT03304743     History of Changes
Other Study ID Numbers: P-001
First Posted: October 9, 2017    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Information with regards to study participants will be kept confidential and managed in accordance with the Data Protection Act 198.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr Elena Calciolari, University of Parma:
dental panoramic radiographs
osteoporosis
feasibility study

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases