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Zoledronate Early to Hip Fracture Patients - Safe and Effective? (ZEBRA)

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ClinicalTrials.gov Identifier: NCT05025293
Recruitment Status : Recruiting
First Posted : August 27, 2021
Last Update Posted : December 16, 2021
Sponsor:
Collaborators:
Vestre Viken Hospital Trust
Roche Diagnostics
Information provided by (Responsible Party):
Lene Bergendal Solberg, Oslo University Hospital

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 3 days) after hip fracture surgery is as good as zoledronate given late (3 months) after hip fracture surgery.

Condition or disease Intervention/treatment Phase
Hip Fractures Osteoporosis Drug: Zoledronic Acid 5Mg/Bag 100Ml Inj Drug: sodium chloride Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blinded randomized controlled non-inferiority trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Zoledronate Early to Hip Fracture Patients - Safe and Effective? A Double-blinded Randomized Controlled Treatment Strategy Trial on Zoledronate in Hip Fracture Patients
Actual Study Start Date : December 15, 2021
Estimated Primary Completion Date : December 1, 2024
Estimated Study Completion Date : December 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Drug: Zoledronic Acid 5Mg/Bag 100Ml Inj
100ml Zoledronic acid (5mg/100ml) administered intravenously
Other Names:
  • Zoledronate
  • Aclasta

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.

Drug: Zoledronic Acid 5Mg/Bag 100Ml Inj
100ml Zoledronic acid (5mg/100ml) administered intravenously
Other Names:
  • Zoledronate
  • Aclasta

Drug: sodium chloride
100ml NaCl 9mg/ml administered intravenously
Other Name: NaCl




Primary Outcome Measures :
  1. Difference between the two groups (ZOLearly vs ZOLlate) in proportion of patients having P1NP>35µg/L 12 months after treatment with zoledronate [ Time Frame: 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


Secondary Outcome Measures :
  1. Grade of early mobilization [ Time Frame: 1-30 days ]
    Measured by Cumulated Ambulation Score (CAS) in hospital and at discharge from hospital. The score range from 0 to 6, where 6 is the best. The patient is scored daily during the stay in hospital.

  2. Delirium assessment [ Time Frame: 1-30 days ]
    Number of patients with delirium assessed by 4 "A" test (4AT) in hospital

  3. Difference between the two groups in proportion of patients having CTX>0.28µg/L 12 months after treatment with zoledronate [ Time Frame: 12 months after treatment with zoledronate ]
    Measured by the bone turnover marker C-telopeptide of type 1 collagen (CTX) (µg/ml) in blood samples

  4. Change in bone mineral density (BMD) [ Time Frame: 12 months after treatment with zoledronate ]
    Measured by dual-energy x-ray absorbtiometry (DXA) in g/cm2 right after hip fracture surgery and after 12 months with zoledronate treatment

  5. Grade of mobilization and rehabilitation [ Time Frame: 3 months after fracture surgery ]
    Measured by Time-up-and-go (TUG) test

  6. Fever (T> 38'C) during hospital stay for fracture surgery [ Time Frame: 1-30 days ]
    Temperature measured in 'C in each patient

  7. Use of antibiotics during hospital stay for fracture surgery [ Time Frame: 1-30 days ]
    Measure duration of antibiotic treatment in each patient

  8. Hospital stay after hip fracture surgery [ Time Frame: 1-30 days ]
    Measure time from admission to discharge from hospital and time from hip fracture surgery to discharge from hospital

  9. Time to readmission to hospital (any department) after first discharge [ Time Frame: 15 months ]
    Measure time to first readmission for each patient

  10. Number of readmissions to hospital (any department) after first discharge [ Time Frame: 15 months ]
    Measure number of readmissions for each patient

  11. Time to new fracture [ Time Frame: 15 months ]
    Measure time to first new fracture after the index fracture for each patient

  12. Total number of new fractures [ Time Frame: 15 months ]
    Measure total number of new fractures

  13. Deaths [ Time Frame: 15 months ]
    Measure total number of deaths


Other Outcome Measures:
  1. Health-related quality of life [ Time Frame: 12 months after treatment with zoledronate ]
    Measured by EQ-5D-5L

  2. Time to fracture healing for the patients with osteosynthesis [ Time Frame: 3 months after fracture treatment ]
    Examined by x-rays and TUG test



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05025293


Contacts
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Contact: Lene B Solberg, PhD MD +4797669950 l.b.solberg@gmail.com
Contact: Elise B Vesterhus, RN uxraea@ous-hf.no

Locations
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Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0424
Contact: Lene B Solberg, PhD    +4797669950    l.b.solberg@gmail.com   
Contact: Elise B Vesterhus, RN       elise.berg.versterhus@gmail.com   
Sponsors and Collaborators
Lene Bergendal Solberg
Vestre Viken Hospital Trust
Roche Diagnostics
Investigators
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Principal Investigator: Solberg B Lene, PhD MD Oslo University Hospital
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Responsible Party: Lene Bergendal Solberg, Principal Investigator, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT05025293    
Other Study ID Numbers: 2018/2234
2020-000638-17 ( EudraCT Number )
First Posted: August 27, 2021    Key Record Dates
Last Update Posted: December 16, 2021
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Lene Bergendal Solberg, Oslo University Hospital:
hip fractures
zoledronic acid
bone turnover markers
delirium
early rehabilitation
bone mineral density
Additional relevant MeSH terms:
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Zoledronic Acid
Osteoporosis
Fractures, Bone
Hip Fractures
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Femoral Fractures
Hip Injuries
Leg Injuries
Bone Density Conservation Agents
Physiological Effects of Drugs