Back to resultsEffect of Actonel on Periodontal Health of Postmenopausal Women
Primary Purpose
Periodontal Disease
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Risedronate
Sponsored by
About this trial
This is an interventional prevention trial for Periodontal Disease focused on measuring osteopenia, periodontitis
Eligibility Criteria
Inclusion Criteria:
- Osteopenia
- Postmenopausal
Exclusion Criteria:
- Male
- Diabetes
Sites / Locations
- Uhcmc
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
E, I
Arm Description
Outcomes
Primary Outcome Measures
Periodontal alveolar bone changes
Secondary Outcome Measures
Periodontal attachment levels
Full Information
NCT ID
NCT00594334
First Posted
January 3, 2008
Last Updated
July 14, 2022
Sponsor
University Hospitals Cleveland Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00594334
Brief Title
Effect of Actonel on Periodontal Health of Postmenopausal Women
Official Title
Effect of Actonel on Periodontal Health of Postmenopausal Women
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Never started
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
January 2011 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals Cleveland Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hypothesis: Women who use Actonel (risedronate) for osteopenia will show beneficial periodontal effects.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Disease
Keywords
osteopenia, periodontitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
E, I
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Risedronate
Intervention Description
Weekly Risedronate
Primary Outcome Measure Information:
Title
Periodontal alveolar bone changes
Time Frame
one year
Secondary Outcome Measure Information:
Title
Periodontal attachment levels
Time Frame
one year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Osteopenia
Postmenopausal
Exclusion Criteria:
Male
Diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
james liu, md
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
leena palomo, dds msd
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uhcmc
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Actonel on Periodontal Health of Postmenopausal Women
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