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OpenTrials
Completed

NCT Number: NCT00004650

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

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.

Completed

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Disease Attributes Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rare Diseases

Age range

0 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conjugated estrogens

Drug

medroxyprogesterone

Drug

Sponsors and collaborators

Lead sponsor

National Institute of Dental and Craniofacial Research (NIDCR)

Nih

Collaborators

  • Washington University School of Medicine

Registry information

Important dates

Study start
1993
First posted
Feb 25, 2000
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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