Treatment with zoledronic acid subsequent to denosumab in osteoporosis

Phase 1

• Conditions: Osteoporosis; MedDRA version: 20.0Level: LLTClassification code 10031289Term: Osteoporosis, unspecifiedSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2015-005529-37-DK
• Lead Sponsor: Bente Lomholt Langdahl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-15
• Last Update Posted: 31 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified