NCT00004650

Brief Summary

OBJECTIVES: I. Quantify periodontal alveolar bone loss rates in postmenopausal women. II. Evaluate the effects of estrogen on alveolar bone loss rates in these patients. III. Determine whether changes in periodontal bone mass relate to bone mass changes in other skeletal sites in these patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1993

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2000

Completed
Last Updated

June 24, 2005

Status Verified

June 1, 1999

First QC Date

February 24, 2000

Last Update Submit

June 23, 2005

Conditions

Osteoporosis

Keywords

disease-related problem/conditionosteoporosisrare disease

Interventions

conjugated estrogensDRUG
MedroxyprogesteroneDRUG

Eligibility Criteria

Age0 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
PROTOCOL ENTRY CRITERIA: * Women postmenopausal for at least 2 years * At least 10 teeth for which radiographic measurements can be obtained, i.e.: Not severely tilted Not so closely spaced that interproximal bone is thin Not in positions of restricted access

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (3)

  • Hildebolt CF, Pilgram TK, Dotson M, Yokoyama-Crothers N, Muckerman J, Hauser J, Cohen S, Kardaris E, Vannier MW, Hanes P, Shrout MK, Civitelli R. Attachment loss with postmenopausal age and smoking. J Periodontal Res. 1997 Oct;32(7):619-25. doi: 10.1111/j.1600-0765.1997.tb00940.x.

    PMID: 9401935BACKGROUND

  • Hildebolt CF. Osteoporosis and oral bone loss. Dentomaxillofac Radiol. 1997 Jan;26(1):3-15. doi: 10.1038/sj.dmfr.4600226.

    PMID: 9446984BACKGROUND

  • Hildebolt CF, Brunsden B, Yokoyama-Crothers N, Pilgram TK, Townsend KE, Vannier MW, Shrout MK. Comparison of reliability of manual and computer-intensive methods for radiodensity measures of alveolar bone loss. Dentomaxillofac Radiol. 1998 Jul;27(4):245-50. doi: 10.1038/sj/dmfr/4600352.

    PMID: 9780904BACKGROUND

MeSH Terms

Conditions

OsteoporosisRare Diseases

Interventions

Estrogens, Conjugated (USP)Medroxyprogesterone

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Estradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsHydroxyprogesteronesProgesteronePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Charles F. Hildebolt

    Washington University School of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

February 24, 2000

First Posted

February 25, 2000

Study Start

August 1, 1993

Last Updated

June 24, 2005

Record last verified: 1999-06