Zoledronate Early to Hip Fracture Patients - Safe and Effective?

NCT05025293 | Recruiting Phase 4 DMC

• 2 other identifiers: 2018/22342020-000638-17
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hip Fractures; Osteoporosis

Keywords

hip fractures; zoledronic acid; bone turnover markers; delirium; early rehabilitation; bone mineral density

Outcome Measures

Primary Outcomes (1)

• Difference between the two groups (ZOLearly vs ZOLlate) in proportion of patients having P1NP>35µg/L 12 months after treatment with zoledronate

  Measured by the bone turnover marker N-terminal propeptide of type 1 procollagen (P1NP) (µg/ml) in blood samples

  12 months after treatment with zoledronate

Secondary Outcomes (13)

• Grade of early mobilization

  1-30 days

• Delirium assessment

  1-30 days

• Difference between the two groups in proportion of patients having CTX>0.28µg/L 12 months after treatment with zoledronate

  12 months after treatment with zoledronate

• Change in bone mineral density (BMD)

  12 months after treatment with zoledronate

• Grade of mobilization and rehabilitation

  3 months after fracture surgery

Other Outcomes (2)

• Health-related quality of life

  12 months after treatment with zoledronate

• Time to fracture healing for the patients with osteosynthesis

  3 months after fracture treatment

Study Arms (2)

ZOLearly

EXPERIMENTAL

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.

Drug: Zoledronic Acid 5Mg/Bag 100Ml Inj

ZOLlate

PLACEBO COMPARATOR

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.

Drug: Zoledronic Acid 5Mg/Bag 100Ml Inj; Drug: sodium chloride

Interventions

Zoledronic Acid 5Mg/Bag 100Ml Inj DRUG

100ml Zoledronic acid (5mg/100ml) administered intravenously

Also known as: Zoledronate, Aclasta

ZOLearly; ZOLlate

sodium chloride DRUG

100ml NaCl 9mg/ml administered intravenously

Also known as: NaCl

ZOLlate

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Metal in the opposite hip
• Anti-osteoporosis treatment with bisphosphonates, denosumab, teriparatide, abaloparatide or romosozumab within the last 10 years
• Glucocorticoid therapy
• Too sick to receive treatment with zoledronate judged by the recruiting or treating physician
• Any other contraindication listed on the SmPC of the IMP(s) including pregnancy
• Participating in another trial that might affect the current study

Sponsors & Collaborators

• Lene Bergendal Solberg: lead
• Vestre Viken Hospital Trust: collaborator
• Roche Diagnostics GmbH: collaborator
• Diakonhjemmet Hospital: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

RECRUITING

MeSH Terms

Conditions

Hip Fractures; Osteoporosis; Delirium

Interventions

Zoledronic Acid; Sodium Chloride

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Solberg B Lene, PhD MD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lene B Solberg, PhD MD

CONTACT

+4797669950; l.b.solberg@gmail.com

Elise B Vesterhus, RN

CONTACT

uxraea@ous-hf.no

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patients are randomized by an electronic system (Viedoc). The randomization is masked for the investigator, the care providers, the participants and the outcomes assessor. Only un-blinded authorized study personnel who prepare the study medicine will see the allocation. The study medicine will be kept in a locked box. Blinded authorized personnel will give the study medication to the patients. The infusions will be covered by a locked box not allowing the patients or others to know the type of infusion.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Double-blinded randomized controlled non-inferiority trial

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 27, 2021
• Study Start: December 15, 2021
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 2, 2024

Record last verified: 2024-04

Locations

NO (1)