Trials / Completed
CompletedNCT00004650
Phase III Randomized Study of the Effect of Postmenopausal Estrogen Replacement Therapy on Alveolar Bone Loss
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 150 (planned)
- Sponsor
- National Institute of Dental and Craniofacial Research (NIDCR) · NIH
- Sex
- Female
- Age
- 0 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | conjugated estrogens | |
| DRUG | Medroxyprogesterone |
Timeline
- Start date
- 1993-08-01
- First posted
- 2000-02-25
- Last updated
- 2005-06-24
Source: ClinicalTrials.gov record NCT00004650. Inclusion in this directory is not an endorsement.