NCT00066027

Effects of Low-Dose Doxycycline on Oral Bone Loss

Low-Dose Doxycycline Effects on Osteopenic Bone Loss

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: Female
• Age: 45 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this clinical trial is to determine whether low-dose doxycycline can reduce alveolar bone density loss in postmenopausal osteopenic women with periodontitis and not on hormone replacement therapy (i.e., estrogen deficient).

Detailed description

The primary purpose of this clinical trial is to determine whether low-dose doxycycline (LDD) can reduce alveolar bone density loss in postmenopausal osteopenic women with periodontitis and not on hormone replacement therapy (i.e., estrogen deficient). The effects of LDD on alveolar bone height loss, progressive periodontal attachment loss, systemic bone mineral density, gingival crevicular fluid biochemical markers of collagen degradation and bone resorption and serum biomarkers of bone formation, bone resorption and inflammation also will be assessed. In addition, another objective is to determine if the microbial effects obtained with LDD over two years are equivalent to a placebo control. This clinical trial involves two clinical sites: the University of Nebraska Medical Center College of Dentistry and Stony Brook University School of Dental Medicine. A total of 128 postmenopausal osteopenic women with periodontitis between the ages of 45 and 70 at the time of telephone screening will be randomized to LDD or placebo groups and subjects will be followed for two years.

Conditions

• Periodontitis

Interventions

Type	Name	Description
DRUG	20 mg doxycycline hyclate	Subjects in the LDD group took 20 mg doxycycline hyclate tablets twice daily for two years
DRUG	Placebo	Subjects in the placebo group took a placebo look-alike twice daily for two years.

Timeline

• Start date: 2002-06-01
• Primary completion: 2005-10-01
• Completion: 2005-10-01
• First posted: 2003-08-05
• Last updated: 2023-09-06

Locations

2 sites across 1 country: United States