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

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ClinicalTrials.gov Identifier: NCT00004650
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
Washington University School of Medicine
Information provided by:
Office of Rare Diseases (ORD)

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: conjugated estrogens Drug: Medroxyprogesterone Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Study Start Date : August 1993

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004650

Sponsors and Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
Washington University School of Medicine
Study Chair: Charles F. Hildebolt Washington University School of Medicine

ClinicalTrials.gov Identifier: NCT00004650     History of Changes
Other Study ID Numbers: 199/11726
First Posted: February 25, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: June 1999

Keywords provided by Office of Rare Diseases (ORD):
disease-related problem/condition
rare disease

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Estrogens, Conjugated (USP)
Medroxyprogesterone Acetate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents