Treatment With Zoledronic Acid Subsequent to Denosumab in Osteoporosis

• Status: Completed
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Denosumab is an antibody against receptor-activator of nuclear factor kappa-B ligand that prevents recruitment and differentiation of mature osteoclasts. Treatment markedly decrease bone resorption and fracture risk, and many patients will reach osteopenic bone mineral density (BMD) levels on treatment with denosumab. The treatment effect on bone turnover and BMD has, however, been demonstrated to be reversible. This study will show if the bone mass can be maintained by administrating zoledronic acid and if timing of the first dose of zoledronic acid after last dose of denosumab matters.

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

Details

• Lead Sponsor: Aarhus University Hospital
• Collaborators: Amgen; University of Aarhus
• Treatments: Denosumab; Diphosphonates; Zoledronic Acid

Criteria

Inclusion Criteria:

• Postmenopausal women (postmenopausal for at least two years)

• Men above 50 years

• Treatment for at least two years with denosumab

• Last denosumab injection less than five months ago

Exclusion Criteria:

• Low-energy vertebral fracture at any time

• Low-energy hip fracture within the last 12 months

• BMD T-score < -2,5 (lumbar spine, total hip or femoral neck)

• Alendronate treatment for more than three years prior to denosumab treatment

• Ongoing treatment with glucocorticoids

• Metabolic bone disease

• Hormone replacement therapy

• Cancer

• Estimated glomerular filtration rate (eGFR) < 35 mL/min

• Allergy to zoledronic acid

• Hypocalcaemia

• Contraindications for zoledronic acid according to the SPC