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
Recruitment status was Recruiting
Sponsor:
University Hospital Case Medical Center
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
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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
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 May 23, 2013