Zoledronic Acid to Maintain Bone Mass After Denosumab Discontinuation

• Status: Completed
• Trial end date: 2018-11-26
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: 424 General Military Hospital
• Collaborators: 251 Hellenic Air Force & VA General Hospital; Leiden University Medical Center
• Treatments: Denosumab; Diphosphonates; Zoledronic Acid

Criteria

Inclusion Criteria:

• postmenopausal women

• osteopenic (T-score > -2.5 but < -1.0) after treatment with denosumab

Exclusion Criteria:

• secondary osteoporosis;

• diseases that could affect bone metabolism;

• medications that could affect bone metabolism;

• history of any antiosteoporotic treatment other than denosumab prior to randomization

• severe liver or kidney disease (creatinine clearance < 60ml/min/1.73m2)