ZAMBA: Zoledronic Acid for Modic Back Pain.

2024-517345-14-00 Protocol ZAMBA Therapeutic confirmatory (Phase III) Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 5 sites · Protocol ZAMBA

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Authorised, recruitment pending
Participants planned 118
Countries 1
Sites 5

Low Back Pain

The objective of this trial is to assess the efficacy and safety of two infusions of 5 mg zoledronic acid is more effective than placebo (NaCl) in reducing back-specific disability, measured by Oswestry disability Index (ODI), in patients with chronic low back pain with Modic changes.

Key facts

Sponsor
Oslo University Hospital HF
Participant type
Patients
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Musculoskeletal Diseases [C05]
Decision date (initial)
2025-01-22
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
Oslo University Hospital

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The objective of this trial is to assess the efficacy and safety of two infusions of 5 mg zoledronic acid is more effective than placebo (NaCl) in reducing back-specific disability, measured by Oswestry disability Index (ODI), in patients with chronic low back pain with Modic changes.

Secondary objectives 1

  1. Improve MRI assessment of Modic changes, health economic analyses, assess underlying biological mechanisms and biomarkers.

Conditions and MedDRA coding

Low Back Pain

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

  1. 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 1

  1. Age <18 and > 65 years and for women with childbearing potential

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Change from baseline at one year in mean Oswestry Disability Index (ODI)-score

Secondary endpoints 1

  1. Change from baseline at one year in mean LBP intensity (three NRS scales), Change from baseline at one year in Roland Morris Disability Questionnaire (RMDQ) score, Change from baseline at one year in EQ-5D, Concomitant treatments (pharm. and non-pharmacological) used between baseline and one-year follow-up, Global perceived effect at one year follow-up

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Aclasta 5 mg solution for infusion

PRD10109345 · Product

Active substance
Zoledronic Acid
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
5 mg milligram(s)
Max total dose
10 mg milligram(s)
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
M05BA08 — ZOLEDRONIC ACID
Marketing authorisation
EU/1/05/308/001
MA holder
SANDOZ PHARMACEUTICALS D.D.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Comparator 1

NaCl 0,9 % B. Braun, solution pour perfusion

PRD5372766 · Product

Active substance
Sodium Chloride
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INFUSION
Max daily dose
100 ml millilitre(s)
Max total dose
200 ml millilitre(s)
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
B05BB01 — ELECTROLYTES
Marketing authorisation
BE121204
MA holder
B.BRAUN MELSUNGEN AG
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Oslo University Hospital HF

73 Total trials 37 Recruiting 25 Ended
Academic / Non-commercial
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
Department of Research and Innovation, Division of Clinical Neuroscience

Public contact point

Organisation
Oslo University Hospital HF
Contact name
Department of Research and Innovation, Division of Clinical Neuroscience

Locations

1 EU/EEA country · 5 investigational sites

By country

CountryMS statusPlanned subjectsSites
Norway Authorised, recruitment pending 118 5
Rest of world — 0 —

Investigational sites

Norway

5 sites · Authorised, recruitment pending
Oslo University Hospital HF
Orthopedic Department, Taarnbygget, Kirkeveien 166, Oslo
University Hospital of Northern Norway
Reumatology, Postboks 100, 9038, Tromsø
Ostfold Hospital Trust
Reumatology Department, P. O. Box 16, 1603, Fredrikstad
St. Olavs Hospital HF
Physical Medicine, P. O. Box 3250, Torgarden, Trondheim
Haukeland University Hospital
Neck and Back Clinic, Haukelandsveien 22, 5009, Bergen

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 17 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol EU CT No 2024 517345 14 00 1.2
Protocol (for publication) D1_Protocol EU CT No 2024 517345 14 00 v1_1 09Dec2024 revisjon clean 1.1
Protocol (for publication) D1_Protocol EU CT No 2024 517345 14 00 v1_1 09Dec2024 revisjon track changes 1.1
Protocol (for publication) D4_ Patient facing documents questionnaire 1
Recruitment arrangements (for publication) K1_ Recruitment arrangements 1
Subject information and informed consent form - Extract (for publication) L1_ SIS and ICF v1_2 30Oct2025_with track changes 1.2
Subject information and informed consent form (for publication) L1_ SIS and ICF 1
Subject information and informed consent form (for publication) L1_ SIS and ICF v1_1 09Dec2024 revisjon clean 1.1
Subject information and informed consent form (for publication) L1_ SIS and ICF v1_1 09Dec2024 revisjon track changes 1.1
Subject information and informed consent form (for publication) L1_ SIS and ICF v1_2 30Oct2025_clean 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_Consentform_genetic analyses_v1_09Dec2024 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Samtykke Nevrovit register_v1_10Sept2020 1
Summary of Product Characteristics (SmPC) (for publication) E2 SmPC Aclasta v1 19May2015 1
Summary of Product Characteristics (SmPC) (for publication) E2_ SmPC NaCl 1
Synopsis of the protocol (for publication) D1_Protocol synopsis MS EU CT No 2024 517345 14 00 1
Synopsis of the protocol (for publication) D1_Protocol synopsis MS EU CT No 2024 517345 14 00 26 v1_1 09Dec24 revisjon clean 1.1
Synopsis of the protocol (for publication) D1_Protocol synopsis MS EU CT No 2024 517345 14 00 26 v1_1 09Dec24 revisjon track changes 1.1

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-10-11 Norway Acceptable
2025-01-22
 2025-01-22
2 NON SUBSTANTIAL MODIFICATION NSM-1 2025-10-30 Norway Acceptable
2025-01-22
 2025-10-30

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