Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004650
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Phase III Randomized Study of the Effect of Postmenopausal Estrogen Replacement Therapy on Alveolar Bone Loss
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1999-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| WUSM-900449 | None | None | None |