Phase III Randomized Study of the Effect of Postmenopausal Estrogen Replacement Therapy on Alveolar Bone Loss
Information source: Office of Rare Diseases (ORD)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis
Intervention: conjugated estrogens (Drug); Medroxyprogesterone (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: National Institute of Dental and Craniofacial Research (NIDCR) Official(s) and/or principal investigator(s):
Charles F. Hildebolt, Study Chair, Affiliation: Washington University School of Medicine
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.
Clinical Details
Study design: Treatment, Randomized, Double-Blind, Active Control, Efficacy Study
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Additional Information
Related publications: 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. Hildebolt CF. Osteoporosis and oral bone loss. Dentomaxillofac Radiol. 1997 Jan;26(1):3-15. Review. 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.
Starting date: August 1993
Last updated: June 23, 2005
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