Bisphosphonates Effects On Alveolar Bone Among Osteoporotic Women

NCT02115490 | Completed DMC

• 1 other identifier: UDDS-OraMed-01-2014
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoporosis

Keywords

Alveolar bone; Bisphosphonates; Cone-beam CT; Osteoporosis

Outcome Measures

Primary Outcomes (1)

• 3D-based Alveolar bone radiographic density

  Bone radiographic density will be assessed using special software of cone beam CT

  One-time assessment; once the woman is scanned by CBCT

Secondary Outcomes (3)

• Alveolar bone histomorphometry

  One-time assessment; once the patient is scanned by CBCT

• 2D-based Alveolar bone radiographic density

  One-time assessment; once the patient is radiographed

• Periodontal Disease Index (PDI)

  One-time assessment in the day of performing the X-ray imaging

Study Arms (2)

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

Interventions

Bisphosphonates DRUG

Osteoporosis_with_Bisphosphonates

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Women with bone diseases other than osteoporosis or osteopenia

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

University of Damascus Dental School

Damascus, Syrian Arab Republic, DM20AM18, Syria

Location

Related Publications (9)

• NIH Consensus Development Panel on Osteoporosis Prevention, Diagnosis, and Therapy, March 7-29, 2000: highlights of the conference. South Med J. 2001 Jun;94(6):569-73. No abstract available.

  PMID: 11440324 BACKGROUND

• Darcey J, Devlin H, Lai D, Walsh T, Southern H, Marjanovic E, Horner K. An observational study to assess the association between osteoporosis and periodontal disease. Br Dent J. 2013 Dec;215(12):617-621. doi: 10.1038/sj.bdj.2013.1191.

  PMID: 24357765 BACKGROUND

• Devlin H. Identification of the risk for osteoporosis in dental patients. Dent Clin North Am. 2012 Oct;56(4):847-61. doi: 10.1016/j.cden.2012.07.010. Epub 2012 Aug 13.

  PMID: 23017555 BACKGROUND

• Doube M, Klosowski MM, Arganda-Carreras I, Cordelieres FP, Dougherty RP, Jackson JS, Schmid B, Hutchinson JR, Shefelbine SJ. BoneJ: Free and extensible bone image analysis in ImageJ. Bone. 2010 Dec;47(6):1076-9. doi: 10.1016/j.bone.2010.08.023. Epub 2010 Sep 15.

  PMID: 20817052 BACKGROUND

• Ho JT, Wu J, Huang HL, Chen MY, Fuh LJ, Hsu JT. Trabecular bone structural parameters evaluated using dental cone-beam computed tomography: cellular synthetic bones. Biomed Eng Online. 2013 Nov 9;12:115. doi: 10.1186/1475-925X-12-115.

  PMID: 24207062 BACKGROUND

• Jeffcoat MK, Cizza G, Shih WJ, Genco R, Lombardi A. Efficacy of bisphosphonates for the control of alveolar bone loss in periodontitis. J Int Acad Periodontol. 2007 Jul;9(3):70-6.

  PMID: 17715838 BACKGROUND

• Kalsi R, Vandana KL, Prakash S. Effect of local drug delivery in chronic periodontitis patients: A meta-analysis. J Indian Soc Periodontol. 2011 Oct;15(4):304-9. doi: 10.4103/0972-124X.92559.

  PMID: 22368351 BACKGROUND

• Karaguzel G, Holick MF. Diagnosis and treatment of osteopenia. Rev Endocr Metab Disord. 2010 Dec;11(4):237-51. doi: 10.1007/s11154-010-9154-0.

  PMID: 21234807 BACKGROUND

• Koh KJ, Kim KA. Utility of the computed tomography indices on cone beam computed tomography images in the diagnosis of osteoporosis in women. Imaging Sci Dent. 2011 Sep;41(3):101-6. doi: 10.5624/isd.2011.41.3.101. Epub 2011 Sep 15.

  PMID: 22010066 BACKGROUND

MeSH Terms

Conditions

Osteoporosis

Interventions

Diphosphonates

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Officials

• Imad Barngkgei, DDS MSc

  PhD student, Department of Oral Medicine, University of Damascus Dental School, Damascus

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2014
• First Posted: April 16, 2014
• Study Start: April 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 29, 2015

Record last verified: 2015-09

Locations

SY (1)