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

This study has been completed.

First Received: February 24, 2000 Last Updated: June 23, 2005 History of Changes

Sponsor:	National Institute of Dental and Craniofacial Research (NIDCR)
Collaborator:	Washington University School of Medicine
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004650

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	Intervention	Phase
Osteoporosis	Drug: conjugated estrogens Drug: Medroxyprogesterone	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Active Control Endpoint Classification: Efficacy Study Masking: Double-Blind Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis

Drug Information available for: Estrogens, conjugated Medroxyprogesterone 17-acetate Medroxyprogesterone

U.S. FDA Resources

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	150
Study Start Date:	August 1993

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

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004650

Sponsors and Collaborators

National Institute of Dental and Craniofacial Research (NIDCR)

Washington University School of Medicine

Investigators

Study Chair:

Charles F. Hildebolt

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.

Study ID Numbers:	199/11726, WUSM-900449
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004650 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

disease-related problem/condition
osteoporosis
rare disease

Additional relevant MeSH terms:

Estrogens
Medroxyprogesterone 17-Acetate
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptive Agents
Contraceptives, Oral
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Osteoporosis
Bone Diseases, Metabolic

Reproductive Control Agents
Contraceptive Agents, Male
Bone Diseases
Hormones
Pharmacologic Actions
Estrogens, Conjugated (USP)
Musculoskeletal Diseases
Therapeutic Uses
Osteoporosis, Postmenopausal
Contraceptives, Oral, Synthetic
Medroxyprogesterone

ClinicalTrials.gov processed this record on March 18, 2010