Effect of Actonel on Periodontal Health of Postmenopausal... | NCT00594334

Studies
Effect of Actonel on Periodontal Health of Postmenopausal Women

NCT00594334

Sponsor

University Hospitals Cleveland Medical Center

Status

Withdrawn

Last Update Posted

Jul 19, 2022Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Periodontal Disease

Interventions

Risedronate

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Never started

Expanded Access Info

Yes

Start Date

Jan 2008

Primary Completion Date

Jan 2010Estimated

Completion Date

Jan 2011Estimated

First Submitted Date

Jan 3, 2008

First Submission Date that Met QC Criteria

Jan 14, 2008

First Posted Date

Jan 15, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2022

Last Update Posted Date

Jul 19, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
E, I	Experimental		Drug: Risedronate

Name	Type	Description	Arm Group Labels	Other Names
Risedronate	Drug	Weekly Risedronate	E, I

Measure	Description	Time Frame
Periodontal alveolar bone changes		one year

Measure	Description	Time Frame
Periodontal attachment levels		one year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Osteopenia
Postmenopausal

Exclusion Criteria:

Male
Diabetes

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
james liu, md	University Hospitals Cleveland Medical Center	Principal Investigator
leena palomo, dds msd	University Hospitals Cleveland Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uhcmc		Cleveland	Ohio	44124	United States

Condition Browse Module

MeSH Terms

ID	Term
D010510	Periodontal Diseases
D001851	Bone Diseases, Metabolic
D010518	Periodontitis

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068296	Risedronic Acid

Ancestor Terms

ID	Term
D004164	Diphosphonates
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided