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

ZOLEDRONATE EARLY TO HIP FRACTURE PATIENTS – SAFE AND EFFECTIVE? A DOUBLE-BLINDED RANDOMIZED CONTROLLED TREATMENT STRATEGY TRIAL ON ZOLEDRONATE IN HIP FRACTURE PATIENTS THE ZEBRA TRIAL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-000638-17-NO

Enrollment

300

Registered

2021-01-04

Start date

2021-03-30

Completion date

Unknown

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Interventions

Trade Name: Aclasta Product Name: Zoledronic Acid Product Code: M05B A08 Pharmaceutical Form: Infusion Pharmaceutical form of the placebo: Infusion Route of administration of the placebo: Intravenous

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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

Countries

Norway

Contacts

Public ContactLene Bergendal Solberg

Oslo University Hospital Ullevål

l.b.solberg@gmail.comNorge97669950

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026