Effect of Actonel on Periodontal Health of Postmenopausal Women

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University Hospital Case Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT00594334
First received: January 3, 2008
Last updated: February 25, 2009
Last verified: February 2009
  Purpose

Hypothesis: Women who use Actonel (risedronate) for osteopenia will show beneficial periodontal effects.


Condition Intervention Phase
Periodontal Disease
Drug: Risedronate
Phase 4

University Hospital Case 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Hospital Case Medical Center:

Primary Outcome Measures:
  • Periodontal alveolar bone changes [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Periodontal attachment levels [ Time Frame: one year ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Osteopenia
  • Postmenopausal

Exclusion Criteria:

  • Male
  • Diabetes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Hospital Case Medical Center
Investigators
Principal Investigator: james liu, md UHCMC
Principal Investigator: leena palomo, dds msd uhcmc
  More Information

No publications provided

Responsible Party: James Liu MD, Leena Palomo DDS MSD, UHCMC
ClinicalTrials.gov Identifier: NCT00594334     History of Changes
Other Study ID Numbers: 010706
Study First Received: January 3, 2008
Last Updated: February 25, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by University Hospital Case Medical Center:
osteopenia
periodontitis

Additional relevant MeSH terms:
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Risedronic acid
Bone Density Conservation Agents
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014