NCT02499237

Zoledronic Acid to Maintain Bone Mass After Denosumab Discontinuation

The Effect of Zoledronic Acid Infusion in the Bone Loss Observed Following Denosumab Discontinuation in Postmenopausal Women With Low Bone Mass

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: 424 General Military Hospital · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

In contrast with bisphosphonates,discontinuation of denosumab results in gradual loss of bone mineral density gains. The investigators aim to evaluate whether in patients treated with denosumab, a single zoledronic acid infusion would prevent the anticipated bone loss.

Detailed description

Discontinuation of denosumab results in a rebound rise of bone turnover markers and gradual loss of the achieved bone mineral density gains. In contrast, bisphosphonates, such as zoledronic acid, remain within the skeleton acting for several months or even years after discontinuation while maintaining bone mineral density despite the cessation of treatment. In this study, the investigators aim to evaluate changes in bone mineral density of the lumbar spine and the femoral neck, as well as in bone turnover markers one year after treatment discontinuation both in denosumab-treated women and in denosumab-treated women who switched to zoledronic acid infusion one year before treatment discontinuation.

Conditions

• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	Denosumab	Treatment of low bone mass with subcutaneous injections of denosumab 60 mg every 6 months for one year
DRUG	Zoledronic acid	Treatment of low bone mass with a single infusion of zoledronic acid 5 mg for one year

Timeline

• Start date: 2015-07-01
• Primary completion: 2018-11-01
• Completion: 2018-11-26
• First posted: 2015-07-16
• Last updated: 2019-03-11

Locations

2 sites across 1 country: Greece