Periodontal Disease and Post-menopausal Osteoporosis

NCT02184962 | Completed DMC

• 2 other identifiers: MEV-2030UNC-2013
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to investigate the levels of RANKL and Osteoprotegerin, and their relationship in gingival crevicular fluid of post-menopausal women with osteoporosis/osteopenia and chronic periodontitis simultaneously and evaluate the effect that the use of bisphosphonates in periodontal disease. Study hypothesis: "The osteoporosis / osteopenia in postmenopausal women patients with periodontal disease affect the ratio RANKL / OPG in gingival crevicular fluid samples favoring osteoclastogenesis processes "

Conditions

Osteoporosis; Osteopenia; Periodontal Disease

Outcome Measures

Primary Outcomes (1)

• levels of RANKL and OPG

  one year

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with osteopenia / osteoporosis and controls with normal osseous condition. Both groups with chronic periodontitis

You may qualify if:

• Women between 45-70 years with Absorptiometry Dual Energy X-ray (DEXA).
• Control group: post-menopausal women with periodontal disease and normal osseous condition.
• Study group: post-menopausal womens with periodontal disease and osteoporosis/osteopenia with and without bisphosphonate treatment (risedronate or ibandronate 150 mg) for longer than 3 months before the study and another.

You may not qualify if:

• Patients with history of aggressive periodontitis and had received any periodontal treatment when they entered the study
• Patients with any systemic illness (except osteopenia/osteoporosis)
• Patients who received antibiotic or non-steroidal anti-inflammatory therapy in the 6 months prior to the study.

Sponsors & Collaborators

• Universidad Nacional de Córdoba: lead

Study Sites (1)

Facultad de Odontología - Universidad Nacional de Córdoba

Córdoba, Córdoba Province, 5000, Argentina

Location

MeSH Terms

Conditions

Osteoporosis; Bone Diseases, Metabolic; Periodontal Diseases

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• María E Verde, Odontóloga

  Facultad de Odontología - UNC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: María Eugenia Verde - Cátedra de Periodoncia A - UNC

Study Record Dates

• First Submitted: July 3, 2014
• First Posted: July 9, 2014
• Study Start: May 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: July 9, 2014

Record last verified: 2014-07

Locations

AR (1)