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Effect of Actonel on Periodontal Health of Postmenopausal Women

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by University Hospitals Cleveland Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00594334
First Posted: January 15, 2008
Last Update Posted: February 26, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospitals Cleveland Medical Center
  Purpose
Hypothesis: Women who use Actonel (risedronate) for osteopenia will show beneficial periodontal effects.

Condition Intervention Phase
Periodontal Disease Drug: Risedronate Phase 4

University Hospitals Cleveland Medical Center has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Actonel on Periodontal Health of Postmenopausal Women

Resource links provided by NLM:


Further study details as provided by University Hospitals Cleveland Medical Center:

Primary Outcome Measures:
  • Periodontal alveolar bone changes [ Time Frame: one year ]

Secondary Outcome Measures:
  • Periodontal attachment levels [ Time Frame: one year ]

Estimated Enrollment: 240
Study Start Date: January 2008
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E, I Drug: Risedronate
Weekly Risedronate

Detailed Description:
Women who use Actonel for osteopenia will show beneficial attachment loss, alveolar bone height and morphology as compared to those who do not when oral hygiene is corrected for.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Osteopenia
  • Postmenopausal

Exclusion Criteria:

  • Male
  • Diabetes
  Contacts and Locations
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): NCT00594334


Contacts
Contact: leena palomo, dds msd 2163686300 leena.palomo@case.edu
Contact: james liu, md 2168443888 james.liu@uhhospitals.org

Locations
United States, Ohio
Uhcmc Recruiting
Cleveland, Ohio, United States, 44124
Principal Investigator: james liu, md         
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Investigators
Principal Investigator: james liu, md UHCMC
Principal Investigator: leena palomo, dds msd uhcmc
  More Information

Responsible Party: James Liu MD, Leena Palomo DDS MSD, UHCMC
ClinicalTrials.gov Identifier: NCT00594334     History of Changes
Other Study ID Numbers: 010706
First Submitted: January 3, 2008
First Posted: January 15, 2008
Last Update Posted: February 26, 2009
Last Verified: February 2009

Keywords provided by University Hospitals Cleveland Medical Center:
osteopenia
periodontitis

Additional relevant MeSH terms:
Periodontal Diseases
Gingival Diseases
Mouth Diseases
Stomatognathic Diseases
Risedronate Sodium
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Bone Density Conservation Agents
Physiological Effects of Drugs