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

Osteoporosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004650
• Other study ID #: 199/11726
• Secondary ID: WUSM-900449
• Status: Completed
• Phase: Phase 3
• First received: February 24, 2000
• Last updated: June 23, 2005
• Start date: August 1993

Study information

• Verified date: June 1999
• Source: Office of Rare Diseases (ORD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• conjugated estrogens

• Medroxyprogesterone

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Dental and Craniofacial Research (NIDCR)	Washington University School of Medicine

References & Publications (3)

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. — View 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. — View Citation

Hildebolt CF. Osteoporosis and oral bone loss. Dentomaxillofac Radiol. 1997 Jan;26(1):3-15. Review. — View Citation