NCT02576652

Bone Histomorphometry in Postmenopausal Men and Women With Osteoarthritis Undergoing Total Hip Replacement

Bone Histomorphometry of the Proximal Femur in Denosumab-treated Subjects Undergoing Total Hip Replacement

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 50 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to determine the incidence of modeling-based bone formation in the femoral neck in participants who have received denosumab and are undergoing total hip replacement (THR).

Conditions

• Osteoporosis

Interventions

Type	Name	Description
OTHER	Tetracycline	Treatment during cycle 1 consists of a total oral dose of 1000 mg of tetracycline daily for a total of 3 days.
OTHER	Demeclocycline	Treatment during cycle 2 consists of a total oral dose of 600 mg of demeclocycline daily for 3 days.
PROCEDURE	Total Hip Replacement	Participants entering this study were prescheduled to undergo elective THR due to osteoarthritis. Surgery was to be performed according to local standard of care. During THR a fragment of femoral bone was acquired for histomorphometry evaluation.

Timeline

• Start date: 2015-12-22
• Primary completion: 2017-12-18
• Completion: 2017-12-18
• First posted: 2015-10-15
• Last updated: 2019-04-26
• Results posted: 2019-04-26

Locations

2 sites across 1 country: United States