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

This study has been completed.
Sponsor:
Collaborator:
Washington University School of Medicine
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004650
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: June 1999
  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 3

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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Washington University School of Medicine
Investigators
Study Chair: Charles F. Hildebolt Washington University School of Medicine
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00004650     History of Changes
Other Study ID Numbers: 199/11726, WUSM-900449
Study First Received: February 24, 2000
Last Updated: June 23, 2005
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
Estrogens, Conjugated (USP)
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Medroxyprogesterone
Medroxyprogesterone Acetate
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on October 19, 2014