Zoledronate early to patients after hip surgery-safe and effective?

Phase 1

• Conditions: Osteoporosis; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2020-000638-17-NO
• Lead Sponsor: Oslo University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-04
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

-Low energy hip fracture
-Surgery within 72 hours
->50 years old
-Acceptable kidney function (eGFR > 35)
-Fit to complete the follow-up in the judgement of the recruiting physician
-Signed informed consent by patient or next of kin
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 270

Exclusion Criteria

-Metal in the opposite hip
-Anti-osteoporotic treatment within the last 10 years
-Not fit for treatment with zoledronate in the judgement of the recruiting physician (moribund, too sick)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Our main hypothesis is that giving zoledronate to patients within 3 days after hip fracture surgery is non-inferior to the anti-fracture effect of giving zoledronate 3 months after hip fracture surgery. ;Secondary Objective: We hypothesize that the risk for delirium, infections, early mobilization and rehabilitation after surgery in hip fracture patients is comparable between giving zoledronate day 1-3 and 3 months after hip fracture surgery. ;Primary end point(s): Bone turnover marker P1NP 12 months after treatment with zoledronate;Timepoint(s) of evaluation of this end point: In hospital, 3, 6 and 12 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Time after treatment with zoledronate;Timepoint(s) of evaluation of this end point: In hospital, 3, 6 and 12 months