Clinical trial • Not applicable • Musculoskeletal
Zoledronic acid for Chronic low back pain | Modic changes
Not applicable trial of Zoledronic acid for Chronic low back pain | Modic changes.
Overview
- Trial Therapeutic Area
- Musculoskeletal
- Trial Disease
- Chronic low back pain | Modic changes
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 11-10-2024
- First CTIS Authorization Date
- 22-01-2025
Trial design
Randomised, placebo comparator: nacl 0.9% (sodium chloride) solution for infusion (nacl 0,9 % b. braun, solution pour perfusion); comparator administered by infusion, matched to active arm schedule (two infusions); product maximums recorded in documentation: max daily volume 100 ml, max total 200 ml.-controlled Not applicable trial across 5 sites in Norway.
- Randomised
- Yes
- Comparator
- Placebo comparator: NaCl 0.9% (sodium chloride) solution for infusion (NaCl 0,9 % B. Braun, solution pour perfusion); comparator administered by infusion, matched to active arm schedule (two infusions); product maximums recorded in documentation: max daily volume 100 ml, max total 200 ml.
- Target Sample Size
- 118
- Trial Duration For Participant
- 365
Eligibility
Recruits 118 No vulnerable population selected; participants are adults (18-65). Informed consent obtained from adult participants using the Subject Information and Informed Consent Form (SIS and ICF) documents; no assent/child consent procedures as minors are excluded..
- Pregnancy Exclusion
- Age <18 and > 65 years and for women with childbearing potential
- Vulnerable Population
- No vulnerable population selected; participants are adults (18-65). Informed consent obtained from adult participants using the Subject Information and Informed Consent Form (SIS and ICF) documents; no assent/child consent procedures as minors are excluded.
Inclusion criteria
- {"criterion_text":"- LBP of > 50% of days for > 6 months duration in the area below the 12th rib and above the gluteal folds with: ODI-score ≥ 30 and/or Numerical Rating Scale (NRS) pain intensity score of ≥ 5 (mean of three NRS scales; current LBP, the worst LBP within the last 2 weeks, and usual/mean LBP within the last 2 weeks), MC containing type 1 at any level Th12-S1 and with craniocaudal height ≥ 10% of vertebral body height and diameter > 5 mm."}
Exclusion criteria
- {"criterion_text":"- Age <18 and > 65 years and for women with childbearing potential"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change from baseline at one year in mean Oswestry Disability Index (ODI)-score","definition_or_measurement_approach":"Change from baseline at one year in mean Oswestry Disability Index (ODI)-score measured by ODI at baseline and at one year"}
Secondary endpoints
- {"endpoint_text":"- Change from baseline at one year in mean LBP intensity (three NRS scales)","definition_or_measurement_approach":"Measured by three Numerical Rating Scales (current LBP, worst LBP within last 2 weeks, usual/mean LBP within last 2 weeks) and change from baseline at one year"}
- {"endpoint_text":"- Change from baseline at one year in Roland Morris Disability Questionnaire (RMDQ) score","definition_or_measurement_approach":"Measured by RMDQ score at baseline and one year; change from baseline at one year"}
- {"endpoint_text":"- Change from baseline at one year in EQ-5D","definition_or_measurement_approach":"Measured by EQ-5D at baseline and one year; change from baseline at one year"}
- {"endpoint_text":"- Concomitant treatments (pharm. and non-pharmacological) used between baseline and one-year follow-up","definition_or_measurement_approach":"Recorded use of concomitant pharmacological and non-pharmacological treatments between baseline and one-year follow-up"}
- {"endpoint_text":"- Global perceived effect at one year follow-up","definition_or_measurement_approach":"Patient-reported global perceived effect assessed at one year follow-up"}
Other endpoints
- {"endpoint_text":"- Improve MRI assessment of Modic changes","definition_or_measurement_approach":""}
- {"endpoint_text":"- health economic analyses","definition_or_measurement_approach":""}
- {"endpoint_text":"- assess underlying biological mechanisms and biomarkers","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 118
- Recruitment Window Months
- 43
- Consent Approach
- Informed consent is obtained using the Subject Information and Informed Consent Form (L1_SIS and ICF) documents (multiple versions available). Specific consent forms for genetic analyses and for the Nevrovit register are included. Participants are adults (18-65) who provide their own consent; no assent process for minors is applicable. Languages of documents are not specified in the available data.
Geography
- Total Number Of Sites
- 5
- Total Number Of Participants
- 118
Norway
- Earliest CTIS Part Ii Submission Date
- 19-12-2024
- Latest Decision Or Authorization Date
- 30-10-2025
- Processing Time Days
- 315
- Number Of Sites
- 5
- Number Of Participants
- 118
Sites
- Site Name
- St. Olavs Hospital HF
- Department Name
- Physical Medicine
- Contact Person Name
- Marthe Halsan Liff
- Contact Person Email
- marthe.halsan.liff@stolav.no
- Site Name
- Oslo University Hospital HF
- Department Name
- Orthopedic Department
- Contact Person Name
- Lene Bergendal Solberg
- Contact Person Email
- lenser@ous-hf.no
- Site Name
- Ostfold Hospital Trust
- Department Name
- Reumatology Department
- Contact Person Name
- Anne Julsrud Haugen
- Contact Person Email
- Anne.Julsrud.Haugen@so-hf.no
- Site Name
- University Hospital of Northern Norway
- Department Name
- Reumatology
- Contact Person Name
- Gunnstein Bakland
- Contact Person Email
- gunnstein.bakland@unn.no
- Site Name
- Haukeland University Hospital
- Department Name
- Neck and Back Clinic
- Contact Person Name
- Thomas Kadar
- Contact Person Email
- thomas.istvan.edelsvard.kadar@helse-bergen.no
Sponsor
Primary sponsor
- Full Name
- Oslo University Hospital HF
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Norway
Investigational products
- Investigational Product Name
- Aclasta 5 mg solution for infusion
- Active Substance
- Zoledronic acid
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised (marketing authorisation EU/1/05/308/001)
- Starting Dose
- 5 mg
- Dose Levels
- 5 mg
- Frequency
- Two infusions (as per trial objective)
- Maximum Dose
- 10 mg
- Investigational Product Name
- NaCl 0,9 % B. Braun, solution pour perfusion
- Active Substance
- Sodium chloride
- Modality
- Small molecule
- Routes Of Administration
- INFUSION
- Route
- INFUSION
- Authorisation Status
- Authorised (marketing authorisation BE121204)
- Starting Dose
- 100 ml
- Dose Levels
- up to 100 ml
- Frequency
- Two infusions (matched to active arm)
- Maximum Dose
- 200 ml
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