Effect of Actonel on Periodontal Health of Postmenopausal Women

• Sponsor: University Hospitals Cleveland Medical Center (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT00594334
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arm: 1
• Duration (Months): 36
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Periodontal Disease	Drug: Risedronate	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Effect of Actonel on Periodontal Health of Postmenopausal Women
• Study Start Date: Jan 1, 2008
• Anticipated Primary Completion Date: Jan 1, 2010
• Anticipated Study Completion Date: Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: E, I	Drug: Risedronate; Weekly Risedronate

Outcome Measures

Primary Outcome Measures

1. Periodontal alveolar bone changes [one year]

Secondary Outcome Measures

1. Periodontal attachment levels [one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Osteopenia

• Postmenopausal

Exclusion Criteria:

• Male

• Diabetes

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Uhcmc	Cleveland	Ohio	United States	44124

Sponsors and Collaborators

• University Hospitals Cleveland Medical Center

Investigators

• Principal Investigator: james liu, md, University Hospitals Cleveland Medical Center
• Principal Investigator: leena palomo, dds msd, University Hospitals Cleveland Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospitals Cleveland Medical Center
• ClinicalTrials.gov Identifier: NCT00594334
• Other Study ID Numbers: 010706
• First Posted: Jan 15, 2008
• Last Update Posted: Jul 19, 2022
• Last Verified: Jul 1, 2022

• Keywords provided by University Hospitals Cleveland Medical Center: osteopenia; periodontitis
• Additional relevant MeSH terms: Periodontal Diseases; Risedronic Acid

Study Results

No Results Posted as of Jul 19, 2022