Phase III Randomized Study of the Effect of Postmenopausal Estrogen Replacement Therapy on Alveolar Bone Loss
|ClinicalTrials.gov Identifier: NCT00004650|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
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|
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)|
|Enrollment :||150 participants|
|Study Start Date :||August 1993|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004650
|Study Chair:||Charles F. Hildebolt||Washington University School of Medicine|