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

First Received on January 3, 2008. Last Updated on February 25, 2009 History of Changes

Sponsor:	University Hospital Case Medical Center
Information provided by:	University Hospital Case Medical Center
ClinicalTrials.gov Identifier:	NCT00594334

Purpose

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

Condition	Intervention	Phase
Periodontal Disease	Drug: Risedronate	Phase IV

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:

Drug Information available for: Risedronic acid Risedronate sodium

U.S. FDA Resources

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

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
Physiological Effects of Drugs

Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012