Phase III Randomized Study of the Effect of Postmenopausal Estrogen Replacement Therapy on Alveolar Bone Loss
Phase 3
Completed
- Conditions
- Osteoporosis
- Registration Number
- NCT00004650
- Lead Sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 150
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method