Alendronic acid (Alendronate) for Osteoporosis

Inclusion criteria

• {"criterion_text":"-Female, Postmenopausal, Current treatment with Alendronate, Alendronate treatment >3 år AND no previous major osteoporotic fracture OR Alendronate treatment >5 år AND latest major osteporotic fracture > 3 years ago, ** Major osteoprotic fracture is defined as low energy fractures in hip, proximal humerus, distal radius, or vertebral fracture"}

Exclusion criteria

• {"criterion_text":"-T-score < - 3,5 in hip (total hip or femoral neck) or lumbar spine, Treatment with systemic glucocorticoids for more than two weeks, ongoing or within 12 months, Uncontrolled inflammatory disease, Active malignancy, eGFR < 40 mL/min, Atypical femur fracture (ever), OsteoNecrosis of the Jaw (active), Unable to give inform consent"}

Primary endpoints

• {"endpoint_text":"-Incidence of fragility fractures during the study periode","definition_or_measurement_approach":"Not further defined in the record; stated as incidence of fragility fractures during the study period."}

Secondary endpoints

• {"endpoint_text":"-Changes in BMD spine and hip from inclusion to study end (3 years), Changes in Bone Turnover Markers over the study period (CTX and P1NP),Proportion of patients meeting restart criteria ,Adverse events.","definition_or_measurement_approach":"Changes in BMD spine and hip measured from inclusion to study end (3 years); Bone turnover markers (CTX and P1NP) measured over study period; proportion meeting restart criteria (criteria not specified here); adverse events recorded (details not specified here)."}

Denmark

Earliest CTIS Part Ii Submission Date

15-07-2024

Latest Decision Or Authorization Date

08-08-2025

Processing Time Days

389

Number Of Sites

8

Number Of Participants

1400

Primary sponsor

Full Name

Odense University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":"sponsorDuties codes: 1, 8","organisation_type":"Hospital/Clinic/Other health care facility"}