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



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

For Condition: Osteoporosis
Status: Completed
Sponsor(s): National Institute of Dental and Craniofacial Research (NIDCR) , Washington University School of Medicine
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Active Control, Efficacy Study
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry 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
Total Enrollment: 150

Location and Contact Information:

Overall Study Official:
CharlesHildebolt,  Study Chair,  Washington University School of Medicine


Additional Information:
Study ID Numbers:
  199/11726;  WUSM-900449
Study Start Date: August 1993
Record last reviewed: June 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004650

Other Osteoporosis Studies:
1. Improving Bone Health in Adolescent Girls: The Youth Osteoporosis and Understanding Total Health (YOUTH) Study

2. CVD Risk and Health in Postmenopausal Phytoestrogen Users

3. Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis

4. Building Better Bones in Children

5. Phase 2 Study assessing AMG 162 in the treatment of women with low bone density

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

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