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Clinical Trial: Phase III Randomized Study of the Effect of Postmenopausal Estrogen Replacement Therapy on Alveolar Bone Loss
This study has been completed.
|
Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Osteoporosis | Drug: conjugated estrogens Drug: Medroxyprogesterone | Phase III |
MedlinePlus related topics: Osteoporosis
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Efficacy Study
Expected Total Enrollment: 150
Study start: August 1993
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
Genders Eligible for Study: 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
Location Information
Charles F. Hildebolt, Study Chair, Washington University School of Medicine
More Information
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.
Record last reviewed: June 1999
Last Updated: October 13, 2004
Record first received: February 24, 2000
ClinicalTrials.gov Identifier: NCT00004650
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Conjugated Estrogen Vaginal Cream (Drug Digest)
- Premarin Vaginal Cream (Drug Digest)
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