NCT00594334

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2008

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 15, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

2 years

First QC Date

January 3, 2008

Last Update Submit

July 14, 2022

Conditions

Periodontal Disease

Keywords

osteopeniaperiodontitis

Outcome Measures

Primary Outcomes (1)

  • Periodontal alveolar bone changes

    one year

Secondary Outcomes (1)

  • Periodontal attachment levels

    one year

Study Arms (1)

E, I

EXPERIMENTAL
Drug: Risedronate

Interventions

RisedronateDRUG

Weekly Risedronate

E, I

Eligibility Criteria

Age40 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Osteopenia
  • Postmenopausal

You may not qualify if:

  • Male
  • Diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhcmc

Cleveland, Ohio, 44124, United States

Location

MeSH Terms

Conditions

Periodontal DiseasesBone Diseases, MetabolicPeriodontitis

Interventions

Risedronic Acid

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • james liu, md

    University Hospitals Cleveland Medical Center

    PRINCIPAL INVESTIGATOR

  • leena palomo, dds msd

    University Hospitals Cleveland Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

January 3, 2008

First Posted

January 15, 2008

Study Start

January 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2011

Last Updated

July 19, 2022

Record last verified: 2022-07

Locations

US(1)