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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
History of Changes
  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:

MedlinePlus related topics: Osteoporosis
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:

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:
Alveolar Bone Loss
Osteoporosis
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Bone Diseases, Metabolic
Estrogens, Conjugated (USP)
Estrogens
Medroxyprogesterone
Medroxyprogesterone Acetate
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 23, 2013