Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT03087851
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT03087851
Study Brief:
Protocol Section:
NCT03087851