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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:
ClinicalTrials.gov Identifier:
NCT00004650
First Posted: February 25, 2000
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Washington University School of Medicine
Information provided by:
Office of Rare Diseases (ORD)
February 24, 2000
February 25, 2000
December 9, 2005
August 1993
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No Changes Posted
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Phase III Randomized Study of the Effect of Postmenopausal Estrogen Replacement Therapy on Alveolar Bone Loss
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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.

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.

Interventional
Phase 3
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Osteoporosis
  • Drug: conjugated estrogens
  • Drug: Medroxyprogesterone
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
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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
Sexes Eligible for Study: Female
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
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NCT00004650
199/11726
WUSM-900449
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National Institute of Dental and Craniofacial Research (NIDCR)
Washington University School of Medicine
Study Chair: Charles F. Hildebolt Washington University School of Medicine
Office of Rare Diseases (ORD)
June 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP