Phase III Randomized Study of the Effect of Postmenopausal Estrogen Replacement Therapy on Alveolar Bone Loss - Full Text View

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

This study has been completed.

Sponsors and Collaborators:	National Institute of Dental and Craniofacial Research (NIDCR) 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

MedlinePlus related topics:

Osteoporosis

Drug Information available for:

Medroxyprogesterone Medroxyprogesterone 17-acetate Estrogens, conjugated

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Efficacy Study

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
First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004650
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

disease-related problem/condition

osteoporosis

rare disease

Study placed in the following topic categories:

Estrogens, Conjugated (USP)

Medroxyprogesterone 17-Acetate

Musculoskeletal Diseases

Rare Diseases

Osteoporosis

Medroxyprogesterone

Bone Diseases, Metabolic

Alveolar Bone Loss

Bone Diseases

Additional relevant MeSH terms:

Estrogens

Antineoplastic Agents, Hormonal

Antineoplastic Agents

Contraceptive Agents

Physiological Effects of Drugs

Contraceptives, Oral

Hormones, Hormone Substitutes, and Hormone Antagonists

Contraceptive Agents, Female

Reproductive Control Agents

Contraceptive Agents, Male

Hormones

Pharmacologic Actions

Therapeutic Uses

Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on November 20, 2008