NCT03623633

Comparative Antiresorptive Efficacy Discontinuation of Denosumab

Comparative Antiresorptive Efficacy of Alendronate or Raloxifene Following Discontinuation of Denosumab

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Female
• Age: 45 Years
• Healthy volunteers: Accepted

Summary

Osteoporosis remains a significant healthcare burden for the United States. Current FDA-approved osteoporosis treatments include teriparatide, abaloparatide, bisphosphonates, denosumab, and raloxifene. Denosumab is a fully human monoclonal antibody that specifically binds to receptor activator of nuclear factor kappa-B ligand (RANKL). Denosumab potently suppresses osteoclastic activity but bone turnover rapidly normalizes and bone turnover marker levels can rebound above baseline levels after the drug is discontinued. This study will help us determine the optimal duration and relative efficacy of two oral antiresorptive medications that are FDA-approved for treatment of postmenopausal osteoporosis (alendronate and raloxifene) in preventing the rebound increase in bone turnover that occurs after denosumab discontinuation.

Conditions

• Osteoporosis, Postmenopausal
• Osteoporosis

Interventions

Type	Name	Description
DRUG	denosumab	denosumab 60 milligrams subcutaneously every 6 months
DRUG	alendronate	alendronate 70 milligrams weekly
DRUG	raloxifene	raloxifene 60 milligrams daily

Timeline

• Start date: 2018-11-30
• Primary completion: 2023-02-01
• Completion: 2023-08-01
• First posted: 2018-08-09
• Last updated: 2023-06-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study