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Phase III Randomized Study of the Effect of Postmenopausal Estrogen Replacement Therapy on Alveolar Bone Loss

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
conjugated estrogens
Medroxyprogesterone
Sponsored by
National Institute of Dental and Craniofacial Research (NIDCR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring disease-related problem/condition, osteoporosis, rare disease

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2000
    Last Updated
    June 23, 2005
    Sponsor
    National Institute of Dental and Craniofacial Research (NIDCR)
    Collaborators
    Washington University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004650
    Brief Title
    Phase III Randomized Study of the Effect of Postmenopausal Estrogen Replacement Therapy on Alveolar Bone Loss
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 1999
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1993 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Institute of Dental and Craniofacial Research (NIDCR)
    Collaborators
    Washington University School of Medicine

    4. Oversight

    5. Study Description

    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.
    Detailed Description
    PROTOCOL OUTLINE: This is a randomized, double-blind, placebo controlled study. Patients are randomly assigned to receive placebo or conjugated estrogens and, if no prior hysterectomy, medroxyprogesterone. Patients also receive calcium supplementation therapy daily for 3 years. Participants in the placebo group may be removed from study if bone loss exceeds 5% per year. A study duration of 3 years is anticipated.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoporosis
    Keywords
    disease-related problem/condition, osteoporosis, rare disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    150 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    conjugated estrogens
    Intervention Type
    Drug
    Intervention Name(s)
    Medroxyprogesterone

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    0 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Charles F. Hildebolt
    Organizational Affiliation
    Washington University School of Medicine
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    9401935
    Citation
    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.
    Results Reference
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    PubMed Identifier
    9446984
    Citation
    Hildebolt CF. Osteoporosis and oral bone loss. Dentomaxillofac Radiol. 1997 Jan;26(1):3-15. doi: 10.1038/sj.dmfr.4600226.
    Results Reference
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    PubMed Identifier
    9780904
    Citation
    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.
    Results Reference
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    Phase III Randomized Study of the Effect of Postmenopausal Estrogen Replacement Therapy on Alveolar Bone Loss

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