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

January 3, 2008
February 25, 2009
January 2008
January 2010   (final data collection date for primary outcome measure)
Periodontal alveolar bone changes [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00594334 on ClinicalTrials.gov Archive Site
Periodontal attachment levels [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effect of Actonel on Periodontal Health of Postmenopausal Women
Effect of Actonel on Periodontal Health of Postmenopausal Women

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Periodontal Disease
Drug: Risedronate
Weekly Risedronate
Experimental: E, I
Intervention: Drug: Risedronate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
January 2011
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Osteopenia
  • Postmenopausal

Exclusion Criteria:

  • Male
  • Diabetes
Female
40 Years to 80 Years
Yes
Contact: leena palomo, dds msd 2163686300 leena.palomo@case.edu
Contact: james liu, md 2168443888 james.liu@uhhospitals.org
United States
 
NCT00594334
010706
No
James Liu MD, Leena Palomo DDS MSD, UHCMC
University Hospital Case Medical Center
Not Provided
Principal Investigator: james liu, md UHCMC
Principal Investigator: leena palomo, dds msd uhcmc
University Hospital Case Medical Center
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP