Bisphosphonates Effects On Alveolar Bone Among Osteoporotic Women

September 26, 2015 updated by: Damascus University

The Effect of Orally Administered Bisphosphonates in the Treatment of Osteoporosis on the Alveolar Bone Using Panoramic and Cone-Beam CT Imaging: A Case-control Study

Osteoporosis is a public health problem. It is a skeletal disease being treated by Bisphosphonates as the first choice medication. The effects of these drugs were investigated for periodontal disease treatment both locally and systemically. However, it is very important to know their indirect effects on alveolar bone (i.e. their effects when used for treating osteoporosis). So, in this study, alternations that involve the alveolar bone when osteoporotic women use bisphosphonates will be studied radiologically using cone-beam CT and digital panoramic radiography. The goal is to provide dentists with information about changes in the characterization of the alveolar bone among these women. This is important for both periodontology and implantology. Maxillary and mandibular bone structural characterization among osteoporotic women had not been studied before. Furthermore, in an opposite direction, dental radiographs may aid in detecting osteoporosis.

Osteoporotic women, under bisphosphonates therapy or not, will be invited to participate in this study. In addition, osteopenic and normal women regarding bone fragility will be included too, for comparison purposes. Panoramic radiographs will be taken. In addition, women under bisphosphonates for 6 months or more will be scanned by Cone -beam CT as it can give an idea about bone histomorphometry with a low radiation dose.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Osteoporosis is a skeletal disease characterized by a low bone mass, deterioration of the bone structure and an increased risk of bone fracture. Although jaws are not at risk of fracture, they revealed changes due to the disease. Bisphosphonates are the most common medical therapy for osteoporosis as they improve bone structure and reduce its absorption. From a periodontal point of view, it was suggested as an adjunctive therapy for periodontal bone loss. Controversy exists regarding their effects, however. In addition, their effects on the periodontal status and jaw bones are unknown when these drugs are prescribed for treating osteoporosis, i.e. not for periodontal purposes. It is also unknown whether their effects on alveolar bone, if any, can be detected by simple radiographs (such as panoramic radiographs) or required advanced techniques (e.g. Cone-beam CT).

In this study, their effects on alveolar bone are going to be evaluated using panoramic radiography and Cone-beam CT, as well as the clinical parameters of periodontal diseases. Cone-beam CT will also offer a way to compare bone histomorphometry of the jaws between groups. Bisphosphonates will be prescribed by physicians of osteoporotic women. The investigators will not interfere drug administration at all. Thus, the investigators can test their indirect effect on jaw bones. Osteoporotic women, who used bisphosphonates for 6 months minimum, will be invited to participate in this investigation. In addition, women with osteoporosis who are not under one of the bisphosphonates will be invited too, as a control. Control group will also include a number of osteopenic and normal women for comparison purposes, as these medications are not indicated for them. Women should be free of bone diseases other than osteoporosis or osteopenia.

On panoramic radiographs, radiographic bone density and mandibular cortical index will be assessed. Aluminum step-wedge will be used with panoramic radiography as it offers more accurate density measurements. In Cone-beam CT, radiographic density, apparent bone histomorphometric analysis and radiographic parameters of the periodontal disease will be assessed. Clinical measurements of periodontal disease will be recorded for two purposes. First, to adjust for the confounding factor (periodontal disease) when evaluating the trabecular bone between groups. Second, to test if using these drugs improve the periodontal status as their benefits are still controversial.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Syrian Arab Republic
      • Damascus, Syrian Arab Republic, DM20AM18
        • University of Damascus Dental School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women who were referred to perform Dual Energy X-Ray Absorptiometry (DXA) examination will be invited to participate in this study if they were diagnosed with osteoporosis. They may be under bisphosphonates or not. They will be met in Alassd and Almowsat University-Hospitals where DXA is available. If they meet inclusion criteria, mentioned below, they will be invited.

Description

Inclusion Criteria:

  • Women with osteoporosis who already use bisphosphonates.
  • Women with osteoporosis who are not under bisphosphonates yet, or are not indicated for such therapy.
  • Women with osteopenia either using or not bisphosphonates.

Exclusion Criteria:

  • Women with bone diseases other than osteoporosis or osteopenia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Osteoporosis_with_Bisphosphonates
This group of patients are taking Bisphosphonates orally in their treatment
Drug: Bisphosphonates
Osteoporosis-without-Bisphosphonates
This group of patients has not taken Bisphosphonates in the course of treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3D-based Alveolar bone radiographic density
Time Frame: One-time assessment; once the woman is scanned by CBCT
Bone radiographic density will be assessed using special software of cone beam CT
One-time assessment; once the woman is scanned by CBCT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alveolar bone histomorphometry
Time Frame: One-time assessment; once the patient is scanned by CBCT
Bone histomorphometry will be assessed using special software used primarily with Micro-CT scans
One-time assessment; once the patient is scanned by CBCT
2D-based Alveolar bone radiographic density
Time Frame: One-time assessment; once the patient is radiographed
This will be assessed using conventional panoramic radiographs
One-time assessment; once the patient is radiographed
Periodontal Disease Index (PDI)
Time Frame: One-time assessment in the day of performing the X-ray imaging
One-time assessment in the day of performing the X-ray imaging

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Investigators

  • Principal Investigator: Imad Barngkgei, DDS MSc, PhD student, Department of Oral Medicine, University of Damascus Dental School, Damascus
  • Study Director: Iyad Al-Haffar, DDS MSc PhD, Associate Professor of Oral Medicine, Department of Oral Medicine, University of Damascus Dental School, Damascus
  • Study Director: Razan Khattab, DDS MSc PhD, Professor of Periodontology, Department of Periodontology, University of Damascus Dental School, Damascus, SYRIA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

April 11, 2014

First Submitted That Met QC Criteria

April 15, 2014

First Posted (Estimate)

April 16, 2014

Study Record Updates

Last Update Posted (Estimate)

September 29, 2015

Last Update Submitted That Met QC Criteria

September 26, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-OraMed-01-2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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