Overview
Sponsor-declared trial summary
Hip fracture
To have zoledronate within 5 days (early) after hip fracture surgery is non-inferior to have zoledronate 3 months (late) after hip fracture surgery measured by the level of bone suppression estimated by the bone turnover marker P1NP 12 months after zoledronate treatment.
Key facts
- Sponsor
- Oslo University Hospital HF
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 1 Dec 2021 → ongoing
- Decision date (initial)
- 2024-06-19
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-510198-32-00
- EudraCT number
- 2020-000638-17
- ClinicalTrials.gov
- NCT20122234
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To have zoledronate within 5 days (early) after hip fracture surgery is non-inferior to have zoledronate 3 months (late) after hip fracture surgery measured by the level of bone suppression estimated by the bone turnover marker P1NP 12 months after zoledronate treatment.
Conditions and MedDRA coding
Hip fracture
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- One low energy hip fracture
- Surgery within 72 hours
- >50 years old - 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 7
- Metal in the opposite hip
- More than one acute fracture (concomitant fracture in addition to hip fracture)
- Anti-osteoporosis treatment with bisphosphonates, denosumab, teriparatid, abaloparatid or romosozumab within the last 10 years
- Glucocorticoid therapy, treatment with gnRH-analogs, aromatase-inhibitors, primary skeletal cancer or metastasis to the skeleton
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Difference between the two groups in proportion of patients having P1NP>35µg/L 12 months after treatment with zoledronate
Secondary endpoints 11
- Grade of early mobilization measured by CAS score in hospital/at discharge from hospital
- Number of patients with delirium assessed by 4AT in hospital
- Difference between the two groups in proportion of patients having CTX>0.28µg/L 12 months after treatment with zoledronate
- Change in BMD 12 months after treatment with zoledronate
- Grade of mobilization and rehabilitation 3 months after fracture measured by TUG test
- Number of patients with fever (T> 38’C) in hospital
- Number of patients treated with antibiotics in hospital
- Time to discharge from hospital after admission and after the hip fracture surgery
- Time to and number of readmissions to hospital (any department)
- Time to and number of new fractures
- Time to and number of deaths
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP1097208 · ATC
- Active substance
- Zoledronic Acid
- Substance synonyms
- ZOLEDRONATE
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 5 mg milligram(s)
- Max total dose
- 5 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- M05BA08 — ZOLEDRONIC ACID
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
—
SCP1023586 · ATC
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 40 millilitre(s)/kilogram
- Max total dose
- 40 millilitre(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05BB01 — ELECTROLYTES
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Oslo University Hospital HF
- Sponsor organisation
- Oslo University Hospital HF
- Address
- Taarnbygget, Kirkeveien 166 Kirkeveien 166
- City
- Oslo
- Postcode
- 0450
- Country
- Norway
Scientific contact point
- Organisation
- Oslo University Hospital HF
- Contact name
- Lene Bergendal Solberg
Public contact point
- Organisation
- Oslo University Hospital HF
- Contact name
- Division of ortopaedic surgery
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Ongoing, recruitment ended | 300 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Norway | 2021-12-01 | 2021-12-01 | 2025-03-31 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-15 | Norway | Acceptable 2024-06-18
|
2024-06-19 |