Zoledronate Early to Hip Fracture Patients - Safe and Effective? A Double-blinded Randomized Controlled Treatment Strategy Trial on Zoledronate in Hip Fracture Patients

Who is this study for? Patients with Hip Fractures, Osteoporosis
What treatments are being studied? Zoledronic Acid
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

To prevent hip fracture patients for having another fracture, secondary fracture preventing medication should be given as soon as possible. Zoledronate is the most efficient bisphosphonate and is given as an intravenous infusion once yearly. However, the appropriate time to initiate zoledronate treatment after a hip fracture has not yet been established. To clarify the optimal timing of zoledronate to hip fracture patients we have designed a double-blinded, placebo-controlled randomized non-inferiority trial to compare if zoledronate administered early (within 5 days) after hip fracture surgery is as good as zoledronate given late (3 months) after hip fracture surgery.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• Low energy hip fracture

• Surgery within 72 hours

• \>50 years old norwegian

• Women age 50-60 must be postmenopausal or not pregnant

• Acceptable kidney function (estimated GFR \>=35) and calcium levels

• Fit to complete the follow-up judged by the recruiting physician

• Signed informed consent by the patient or the next of kin

Locations
Other Locations
Norway
Oslo University Hospital
RECRUITING
Oslo
Contact Information
Primary
Lene B Solberg, PhD MD
l.b.solberg@gmail.com
+4797669950
Backup
Elise B Vesterhus, RN
uxraea@ous-hf.no
Time Frame
Start Date: 2021-12-15
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 300
Treatments
Experimental: ZOLearly
Within 3 days after hip fracture surgery: A single dose of 100 ml containing 5mg zoledronate (Aclasta) will be administered intravenously.~The ZOLearly group will have no further infusions during the study period.
Placebo_comparator: ZOLlate
Within 3 days after hip fracture surgery: A single dose of 100 ml containing 100ml NaCl 9mg/ml (placebo) will be administered intravenously.~3 months after hip fracture surgery (at the out-patient clinic): A single dose of 100 ml containing 5mg zoledronate (Aclasta) will administered intravenously.
Related Therapeutic Areas
Sponsors
Leads: Lene Bergendal Solberg
Collaborators: Roche Diagnostics GmbH, Vestre Viken Hospital Trust, Diakonhjemmet Hospital

This content was sourced from clinicaltrials.gov