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

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ClinicalTrials.gov Identifier: NCT03304743
Recruitment Status : Recruiting
First Posted : October 9, 2017
Last Update Posted : October 12, 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.

While several studies support the use of panoramic indices, they have never been tested in an Italian University Hospital setting and in a study adequately powered and controlled for confounding variables.

The aim of this study is to assess the feasibility of using dental panoramic indices to screen for post-menopausal osteoporosis.


Condition or disease Intervention/treatment
Osteoporosis, Postmenopausal Diagnostic Test: Dental panoramic radiograph

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 124 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Dental Panoramic Radiographs to Screen for Post-menopausal Osteoporosis
Actual Study Start Date : June 12, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: X-Rays

Group/Cohort Intervention/treatment
Post-menopausal women
A cohort of 124 consecutive post-menopausal women that performed a DXA scan within the previous 12 months
Diagnostic Test: Dental panoramic radiograph

If not performed within the previous 12 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.





Primary Outcome Measures :
  1. sensitivity and specificity of Klemetti Index [ Time Frame: 12 months is the maximum time between DXA results and OPT results, so it is also the timing for this outcome measurement ]
    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: 12 months is the maximum time between DXA results and OPT results, so it is also the timing for this outcome measurement ]
    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: 12 months is the maximum time between DXA results and OPT results, so it is also the timing for this outcome measurement ]
    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: 12 months is the maximum time between DXA results and OPT results, so it is also the timing for this outcome measurement ]
    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 post-menopausal women attending a University Dental Hospital (Centro Universitario di Odontoiatria) and identified as osteoporotic with the help of the panoramic indices [ Time Frame: up to 18 months ]
  5. number of osteoporotic women identified as osteoporotic with the help of panoramic indices and their risk of fractures [ Time Frame: At study completion, up to 18 months from the beginning of the study ]
    this will be calculated based on the Italian modified version of FRAX, "DeFRA"



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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
Sampling Method:   Non-Probability Sample
Study Population
All post-menopausal women ≥ 65 years old attending the Centro Universitario di Odontoiatria in the new patients' or follow-ups' clinics will be approached to check for the inclusion/exclusion criteria and their willingness to take part in the study. Furthermore, doctors (general practitioners or osteoporosis specialists) will be contacted and will be kindly asked to inform their patient that had done a DXA scan within the past 12 months about the study. Potentially eligible patients will be booked an appointment at the "Centro Universitario di Odontoiatria, Dipartimento di Medicina e Chirurgia, Università di Parma" to check for inclusion/exclusion criteria and for the recruitment.
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).
  • With a DXA examination at the hip and lumbar spine performed within the previous 12 months

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: October 12, 2018
Last Verified: October 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 data will be pseudo anonymised

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