Osteomyelitis ChronicPhase 2POMREPNCT07668583
EFFICACY AND SAFETY OF ZOLEDRONATE VERSUS PLACEBO ON PAIN AT WEEK 12 IN PEDIATRIC PATIENTS WITH CHRONIC RECURRENT MULTIFOCAL OSTEOMYELITIS
A Phase 2 study testing Zoledronic Acid / Zoledronate 4 MG/100 ML Intravenous Solution and NaCL 0.9% Intravenous Solution in people with Osteomyelitis Chronic, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Chronic recurrent multifocal osteomyelitis (CRMO) is a rare auto-inflammatory bone disease that primarily affects children and/or adolescents at a median age of 10 years. Until now, there is no consensus regarding the treatment of CRMO. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Osteomyelitis Chronic
- What is being tested?
- Zoledronic Acid / Zoledronate 4 MG/100 ML Intravenous Solution and NaCL 0.9% Intravenous Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2026to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- aged ≥4 and <17 years for whom:
- Physician-confirmed diagnosis of CRMO according to Jansson's criteria, with compatible MRI findings. Having lesions on MRI within 12 weeks prior to inclusion and clinically active disease defined by at least one of 2 criteria: patient/parent VAS (pain) superior or equal to 30/100 and/or physician VAS superior or equal to 30/100 after failure of at least 4 weeks of NSAIDs at a stable dose
- Written informed consent signed by the parents (the child may sign the consent if they wish, but their signature is not mandatory)
- Having had a dental review within 3 months prior to inclusion, with completion of any necessary invasive dental work before the first dose of zoledronate.
Who cannot join
- History of malignancy or current tumour
- History of seizure
- Current infectious osteomyelitis
- Contraindication to the study drug
- Hypersensitivity to the active substance, to other bisphosphonates, or to any excipient (sodium hydroxide, hydrochloric acid for pH adjustment, water for injection) ;
- Hypocalcemia ;
Show all 18Show fewer
- Severe renal impairment with creatinine clearance < 35 ml/min ;
- Prior treatment with bisphosphonates and/or biotherapy within 6 months prior to inclusion.
- History of HIV, HBV, or HCV infection.
- Congenital or acquired prolonged QT interval (>0.44 seconds) on ECG.
- Clinically significant vertebral deformities, including vertebral fracture and/or angular kyphosis with risk of spinal cord compression.
- Suspected or confirmed tuberculosis.
- History of renal or hepatic insufficiency.
- Already enrolled in another interventional study.
- Pregnant or breastfeeding participants
- Not affiliated with the French social security system.
- Patient or legal guardians with limited understanding of the French language
- Serum 25-hydroxy vitamin D level <30 ng/mL at screening. Participants may be re-screened after correction of vitamin D deficiency.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Kremlin-Bicêtre Hospital
Le Kremlin-Bicêtre, Val De Marne, 94270
Perrine DUSSER, MD, PhD, +33145213254, perrine.dusser@aphp.fr
About this study
Official title: EFFICACY AND SAFETY OF ZOLEDRONATE VERSUS PLACEBO ON PAIN AT WEEK 12 IN PEDIATRIC PATIENTS WITH CHRONIC RECURRENT MULTIFOCAL OSTEOMYELITIS RESISTANT TO NON-STEROIDAL ANTI-INFLAMMATORY DRUG
Chronic recurrent multifocal osteomyelitis (CRMO) is a rare auto-inflammatory bone disease that primarily affects children and/or adolescents at a median age of 10 years. Until now, there is no consensus regarding the treatment of CRMO. Non-steroidal anti-inflammatory drugs (NSAIDs) are considered the first line of therapy with remission in approximately 30% of cases. If unsuccessful, several treatments are tried in addition to NSAIDs, including bisphosphonates and anti-TNFs.
The effectiveness of bisphosphonates (including zoledronate) has been reported in clinical cases and/or retrospective series. They are said to be particularly effective in multifocal forms, mandibular and/or vertebral involvement, but no controlled trials have been conducted. Bisphosphonates have even been proposed as first-line therapy in spinal involvement. The only prospective study, is a phase II trial currently underway in Denmark to study the efficacy of zoledronate (NCT02594878) versus placebo in SAPHO (acronym, standing for Synovitis - Acne - Pustulosis - Hyperostosis - Osteitis) patients considered to be a very similar form of CRMO occurring in adults.
In this context, this study proposes evaluate the efficacy of zoledronate compared to placebo in reducing pain at week 12 in children aged ≥4 and <17 years with NSAID-resistant CRMO. Zoledronate will be administered in three escalating doses: 0.025 mg/kg at baseline (W0), 0.05 mg/kg at week 12 (W12), and 0.05 mg/kg at week 24 (W24). In addition to pain reduction, improvements in MRI findings will be observed, biological markers of inflammation, and quality of life in the zoledronate group. Although subjective, pain reduction remains the most widely used criterion in clinical practice to assess therapeutic efficacy. Zoledronate efficacy will therefore be assessed by the change in standardized pain score (0-10 scale) from baseline to week 12 as the primary endpoint, with additional pain assessments at weeks 4, 24, and 36 as secondary endpoints.
Read the detailed description
Chronic recurrent multifocal osteomyelitis (CRMO) is a rare auto-inflammatory bone disease that primarily affects children and/or adolescents at a median age of 10 years. Until now, there is no consensus regarding the treatment of CRMO. Non-steroidal anti-inflammatory drugs (NSAIDs) are considered the first line of therapy with remission in approximately 30% of cases. If unsuccessful, several treatments are tried in addition to NSAIDs, including bisphosphonates and anti-TNFs.
The effectiveness of bisphosphonates (including zoledronate) has been reported in clinical cases and/or retrospective series. They are said to be particularly effective in multifocal forms, mandibular and/or vertebral involvement, but no controlled trials have been conducted. Bisphosphonates have even been proposed as first-line therapy in spinal involvement. The only prospective study, is a phase II trial currently underway in Denmark to study the efficacy of zoledronate (NCT02594878) versus placebo in SAPHO (acronym, standing for Synovitis - Acne - Pustulosis - Hyperostosis - Osteitis) patients considered to be a very similar form of CRMO occurring in adults.
In this context, this study proposes to evaluate the efficacy of zoledronate compared to placebo in reducing pain at week 12 in children aged ≥4 and <17 years with NSAID-resistant CRMO. Zoledronate will be administered in three escalating doses: 0.025 mg/kg at baseline (W0), 0.05 mg/kg at week 12 (W12), and 0.05 mg/kg at week 24 (W24). In addition to pain reduction, improvements in MRI findings will be observed, biological markers of inflammation, and quality of life in the zoledronate group. Although subjective, pain reduction remains the most widely used criterion in clinical practice to assess therapeutic efficacy. Zoledronate efficacy will therefore be assessed by the change in standardized pain score (0-10 scale) from baseline to week 12 as the primary endpoint, with additional pain assessments at weeks 4, 24, and 36 as secondary endpoints.
Main objective: To evaluate the efficacy of zoledronate, administered at increasing doses (0.025 mg/kg at baseline, 0.05 mg/kg at week 12, and 0.05 mg/kg at week 24; maximum dose 4 mg per infusion), versus placebo on the change in standardized pain score (0-10 scale) from baseline to week 12 in children aged ≥4 and <17 years with NSAID-resistant CRMO.
Secondary objectives:
- To compare pain evolution between the two groups at weeks 4, 24 and 36 (pain at week 12 being the primary endpoint).
- To compare the use of NSAIDs, other analgesics and corticosteroids between the two groups during follow-up.
- To compare clinical signs (pain on palpation, arthritis, spinal deformity, extra-osseous manifestations, growth and puberty) between the two groups at baseline and follow-up visits.
- To compare biological inflammatory markers between the two groups at baseline and follow-up visits.
- To evaluate disease activity using the CNO Clinical Disease Activity Score (CNO CDAS) between the two groups at baseline and follow-up visits.
- To compare radiological disease activity on whole-body MRI between the two groups at baseline and follow-up visits using the mRINBO score.
- To assess treatment response using PedCNO30 and PedCNO50 score between the two groups at baseline and follow-up visits.
- To compare the rate of radiological remission (early remission at week 12; remission at weeks 24 and 36) between the two groups.
- To compare the rates of clinical and biological remission between the two groups at weeks 12, 24 and 36.
- To evaluate changes in health-related quality of life between the two groups at baseline and follow-up visits.
- To assess the impact on schooling (children) and work absenteeism (parents) between the two groups.
- To evaluate the safety and tolerance of zoledronate.
- To assess the cost-effectiveness of the strategy
- Conditions
- Osteomyelitis Chronic
- Being tested
- Zoledronic Acid / Zoledronate 4 MG/100 ML Intravenous Solution, NaCL 0.9% Intravenous Solution
- Keywords
- Osteomyelitis
- Medical subject headings
- Osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic Acid / Zoledronate 4 MG/100 ML Intravenous SolutionDrug
Baseline : 0.025 mg/kg ; Week 4 : 0.05 mg/kg ; Week 6 : 0.05 mg/kg
NaCL 0.9% Intravenous SolutionOther
Baseline, Week 4 \& Week 6
| Study group | Role | What they receive |
|---|---|---|
| Zoledronate | Experimental | Zoledronic acid, perfusion IV Baseline : 0.025 mg/kg ; Week 12 : 0.05 mg/kg ; Week 24 : 0.05 mg/kg Receives: Drug: Zoledronic Acid / Zoledronate 4 MG/100 ML Intravenous Solution |
| NaCL 0.9% | Placebo comparator | NaCl 0.9%, perfusion IV Baseline Week 12 Week 24 Receives: Other: NaCL 0.9% Intravenous Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain score from baseline to week 12
Change in standardized pain score (0-10 scale) from baseline to week 12, using Visual Analog Scale VAS 0-10/ 0 = no pain ; 10 = worst imaginable pain
Measured: week 12
Secondary outcomes (14)
Compare pain score (0-10 scale) evolution between groups at Weeks 4, 24 and 36
Change in standardized pain score (0-10 scale) from baseline to week 4,24 \&36, using Visual Analog Scale VAS 0-10/ 0 = no pain ; 10 = worst imaginable pain
Measured: Week 4, 24 and 36
Use of NSAIDs, other analgesics and corticosteroids between the two groups during follow-up.
compare the use of NSAIDs, other analgesics and corticosteroids between the two groups during follow-up.
Measured: Week 12, 24 and 36
Clinical signs (Number of participants presenting clinical manifestations of CRMO (pain on palpation, arthritis, spinal deformity, extra-osseous manifestations, growth impairment and pubertal delay) between the two groups at baseline and follow-up visits
Clinical manifestations will be assessed by physical examination at baseline and at weeks 12, 24 and 36. The proportion of participants presenting each manifestation (pain on palpation, arthritis, spinal deformity, dermatological manifestations, inflammatory bowel disease, growth impairment and pubertal delay) will be compared between groups.
Measured: Week 12, 24 and 36
Biological inflammatory markers between the two groups at baseline and follow-up visits.
compare biological inflammatory markers between the two groups at baseline and follow-up visits.
Measured: Week 12, 24 and 36
CNO Clinical Disease Activity Score (CNO CDAS)
The Chronic Nonbacterial Osteomyelitis Clinical Disease Activity Score (CNO CDAS) is a composite disease activity score consisting of three components: (1) patient/parent pain assessment (0-10 visual analog scale), (2) patient/parent global assessment of disease activity (0-10 visual analog scale), and (3) physician assessment of the number of clinically active CNO lesions (0-10). Total scores range from 0 to 30, with higher scores indicating greater disease activity and a worse clinical condition. The CNO CDAS will be assessed at baseline and at weeks 12, 24, and 36.
Measured: Week 12, 24 and 36
Whole-body MRI disease activity assessed by the modified Radiological Index for Non-Bacterial Osteitis (mRINBO)
The mRINBO score will be assessed on whole-body MRI at baseline and follow-up visits. The score incorporates the number of radiologically active lesions, the maximum lesion size (RALmax), extramedullary inflammatory changes, and chronic radiological changes. Higher scores indicate greater radiological disease activity. Whole-body MRI assessments will be performed at baseline and at weeks 12, 24, and 36.
Measured: Week 12, 24 and 36
Proportion of participants achieving PedCNO30 response at week 36
PedCNO30 is defined as at least 30% improvement in at least three of five core variables, with no more than one variable worsening by >30%.
Measured: week 36
Radiological remission
Compare the rate of radiological remission (early remission at week 12; remission at weeks 24 and 36) between the two groups.
Measured: Week 12, 24 and 36
Clinical and biological remission
compare the rates of clinical and biological remission between the two groups at weeks 12, 24 and 36.
Measured: Week 12, 24 and 36
Health-related quality of life assessed by the Pediatric Quality of Life Inventory (PedsQL)
PedsQL total score ranges from 0 to 100. Higher scores indicate better health-related quality of life.
Measured: week 36
Number of days of school absenteeism (children) and work absenteeism (parents) recorded using the electronic patient-reported outcome (ePRO) diary, during each 12-week period
School and parental absenteeism will be assessed as the number of days missed from school by the child and the number of days missed from work by the parent during the previous 12 weeks. Data will be collected using the electronic patient-reported outcome (ePRO) diary and compared between treatment groups.
Measured: week 36
Safety and tolerability of zoledronate, assessed by the incidence of adverse events and serious adverse events during the 36-week follow-up period
Measured: week 36
Incremental cost-effectiveness ratio (ICER) of zoledronate versus placebo at week 36
Cost-effectiveness will be assessed by estimating the incremental cost-effectiveness ratio (ICER), expressed as cost per quality-adjusted life year (QALY) gained.
Measured: week 36
Proportion of participants achieving PedCNO50 response at week 36
PedCNO50 is defined as at least 50% improvement in at least three of five core variables, with no more than one variable worsening by >50%.
Measured: week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start15 Sep 2026 (estimated)
- Primary completion15 Mar 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteomyelitis ChronicStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- POMREP is a double-blinded multicentre prospective phase II proof-of-concept randomised controlled trial (parallel group 2:1) evaluating the efficacy of Zoledronate over a placebo in reducing pain for pediatric patients with CRMO.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Perrine DUSSER, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668583
- Sponsor's protocol ID
- APHP220795
- Other IDs
- 2023-506420-93-00, 2023
- Acronym
- POMREP
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFICACY AND SAFETY OF ZOLEDRONATE VERSUS PLACEBO ON PAIN AT WEEK 12 IN PEDIATRIC PATIENTS WITH CHRONIC RECURRENT MULTIFOCAL OSTEOMYELITIS RESISTANT TO NON-STEROIDAL ANTI-INFLAMMATORY DRUG
- ClinicalTrials.gov ID
- NCT07668583
- Acronym / sponsor ID
- POMREP / APHP220795
- Conditions
- Osteomyelitis Chronic
- Keywords
- Osteomyelitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 15 Mar 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic recurrent multifocal osteomyelitis (CRMO) is a rare auto-inflammatory bone disease that primarily affects children and/or adolescents at a median age of 10 years. Until now, there is no consensus regarding the treatment of CRMO. Non-steroidal anti-inflammatory drugs (NSAIDs) are considered the first line of therapy with remission in approximately 30% of cases. If unsuccessful, several treatments are tried in addition to NSAIDs, including bisphosphonates and anti-TNFs.
The effectiveness of bisphosphonates (including zoledronate) has been reported in clinical cases and/or retrospective series. They are said to be particularly effective in multifocal forms, mandibular and/or vertebral involvement, but no controlled trials have been conducted. Bisphosphonates have even been proposed as first-line therapy in spinal involvement. The only prospective study, is a phase II trial currently underway in Denmark to study the efficacy of zoledronate (NCT02594878) versus placebo in SAPHO (acronym, standing for Synovitis - Acne - Pustulosis - Hyperostosis - Osteitis) patients considered to be a very similar form of CRMO occurring in adults.
In this context, this study proposes evaluate the efficacy of zoledronate compared to placebo in reducing pain at week 12 in children aged ≥4 and <17 years with NSAID-resistant CRMO. Zoledronate will be administered in three escalating doses: 0.025 mg/kg at baseline (W0), 0.05 mg/kg at week 12 (W12), and 0.05 mg/kg at week 24 (W24). In addition to pain reduction, improvements in MRI findings will be observed, biological markers of inflammation, and quality of life in the zoledronate group. Although subjective, pain reduction remains the most widely used criterion in clinical practice to assess therapeutic efficacy. Zoledronate efficacy will therefore be assessed by the change in standardized pain score (0-10 scale) from baseline to week 12 as the primary endpoint, with additional pain assessments at weeks 4, 24, and 36 as secondary endpoints.
Detailed description
Chronic recurrent multifocal osteomyelitis (CRMO) is a rare auto-inflammatory bone disease that primarily affects children and/or adolescents at a median age of 10 years. Until now, there is no consensus regarding the treatment of CRMO. Non-steroidal anti-inflammatory drugs (NSAIDs) are considered the first line of therapy with remission in approximately 30% of cases. If unsuccessful, several treatments are tried in addition to NSAIDs, including bisphosphonates and anti-TNFs.
The effectiveness of bisphosphonates (including zoledronate) has been reported in clinical cases and/or retrospective series. They are said to be particularly effective in multifocal forms, mandibular and/or vertebral involvement, but no controlled trials have been conducted. Bisphosphonates have even been proposed as first-line therapy in spinal involvement. The only prospective study, is a phase II trial currently underway in Denmark to study the efficacy of zoledronate (NCT02594878) versus placebo in SAPHO (acronym, standing for Synovitis - Acne - Pustulosis - Hyperostosis - Osteitis) patients considered to be a very similar form of CRMO occurring in adults.
In this context, this study proposes to evaluate the efficacy of zoledronate compared to placebo in reducing pain at week 12 in children aged ≥4 and <17 years with NSAID-resistant CRMO. Zoledronate will be administered in three escalating doses: 0.025 mg/kg at baseline (W0), 0.05 mg/kg at week 12 (W12), and 0.05 mg/kg at week 24 (W24). In addition to pain reduction, improvements in MRI findings will be observed, biological markers of inflammation, and quality of life in the zoledronate group. Although subjective, pain reduction remains the most widely used criterion in clinical practice to assess therapeutic efficacy. Zoledronate efficacy will therefore be assessed by the change in standardized pain score (0-10 scale) from baseline to week 12 as the primary endpoint, with additional pain assessments at weeks 4, 24, and 36 as secondary endpoints.
Main objective: To evaluate the efficacy of zoledronate, administered at increasing doses (0.025 mg/kg at baseline, 0.05 mg/kg at week 12, and 0.05 mg/kg at week 24; maximum dose 4 mg per infusion), versus placebo on the change in standardized pain score (0-10 scale) from baseline to week 12 in children aged ≥4 and <17 years with NSAID-resistant CRMO.
Secondary objectives:
- To compare pain evolution between the two groups at weeks 4, 24 and 36 (pain at week 12 being the primary endpoint).
- To compare the use of NSAIDs, other analgesics and corticosteroids between the two groups during follow-up.
- To compare clinical signs (pain on palpation, arthritis, spinal deformity, extra-osseous manifestations, growth and puberty) between the two groups at baseline and follow-up visits.
- To compare biological inflammatory markers between the two groups at baseline and follow-up visits.
- To evaluate disease activity using the CNO Clinical Disease Activity Score (CNO CDAS) between the two groups at baseline and follow-up visits.
- To compare radiological disease activity on whole-body MRI between the two groups at baseline and follow-up visits using the mRINBO score.
- To assess treatment response using PedCNO30 and PedCNO50 score between the two groups at baseline and follow-up visits.
- To compare the rate of radiological remission (early remission at week 12; remission at weeks 24 and 36) between the two groups.
- To compare the rates of clinical and biological remission between the two groups at weeks 12, 24 and 36.
- To evaluate changes in health-related quality of life between the two groups at baseline and follow-up visits.
- To assess the impact on schooling (children) and work absenteeism (parents) between the two groups.
- To evaluate the safety and tolerance of zoledronate.
- To assess the cost-effectiveness of the strategy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- POMREP is a double-blinded multicentre prospective phase II proof-of-concept randomised controlled trial (parallel group 2:1) evaluating the efficacy of Zoledronate over a placebo in reducing pain for pediatric patients with CRMO.
| Arm | Type | Receives |
|---|---|---|
| Zoledronate | Experimental | Drug: Zoledronic Acid / Zoledronate 4 MG/100 ML Intravenous SolutionZoledronic acid, perfusion IV Baseline : 0.025 mg/kg ; Week 12 : 0.05 mg/kg ; Week 24 : 0.05 mg/kg |
| NaCL 0.9% | Placebo comparator | Other: NaCL 0.9% Intravenous SolutionNaCl 0.9%, perfusion IV Baseline Week 12 Week 24 |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- aged ≥4 and <17 years for whom:
- Physician-confirmed diagnosis of CRMO according to Jansson's criteria, with compatible MRI findings. Having lesions on MRI within 12 weeks prior to inclusion and clinically active disease defined by at least one of 2 criteria: patient/parent VAS (pain) superior or equal to 30/100 and/or physician VAS superior or equal to 30/100 after failure of at least 4 weeks of NSAIDs at a stable dose
- Written informed consent signed by the parents (the child may sign the consent if they wish, but their signature is not mandatory)
- Having had a dental review within 3 months prior to inclusion, with completion of any necessary invasive dental work before the first dose of zoledronate.
Key exclusion criteria (18 listed)
- History of malignancy or current tumour
- History of seizure
- Current infectious osteomyelitis
- Contraindication to the study drug
- Hypersensitivity to the active substance, to other bisphosphonates, or to any excipient (sodium hydroxide, hydrochloric acid for pH adjustment, water for injection) ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoledronic Acid / Zoledronate 4 MG/100 ML Intravenous SolutionBaseline : 0.025 mg/kg ; Week 4 : 0.05 mg/kg ; Week 6 : 0.05 mg/kg | Drug | Zoledronate |
| NaCL 0.9% Intravenous SolutionBaseline, Week 4 \& Week 6 | Other | NaCL 0.9% |
Primary outcome
Change in pain score from baseline to week 12
Time frame: week 12
Change in standardized pain score (0-10 scale) from baseline to week 12, using Visual Analog Scale VAS 0-10/ 0 = no pain ; 10 = worst imaginable pain
14 secondary outcomes
Compare pain score (0-10 scale) evolution between groups at Weeks 4, 24 and 36
Time frame: Week 4, 24 and 36
Use of NSAIDs, other analgesics and corticosteroids between the two groups during follow-up.
Time frame: Week 12, 24 and 36
Clinical signs (Number of participants presenting clinical manifestations of CRMO (pain on palpation, arthritis, spinal deformity, extra-osseous manifestations, growth impairment and pubertal delay) between the two groups at baseline and follow-up visits
Time frame: Week 12, 24 and 36
Biological inflammatory markers between the two groups at baseline and follow-up visits.
Time frame: Week 12, 24 and 36
CNO Clinical Disease Activity Score (CNO CDAS)
Time frame: Week 12, 24 and 36
Whole-body MRI disease activity assessed by the modified Radiological Index for Non-Bacterial Osteitis (mRINBO)
Time frame: Week 12, 24 and 36
Proportion of participants achieving PedCNO30 response at week 36
Time frame: week 36
Radiological remission
Time frame: Week 12, 24 and 36
Clinical and biological remission
Time frame: Week 12, 24 and 36
Health-related quality of life assessed by the Pediatric Quality of Life Inventory (PedsQL)
Time frame: week 36
Number of days of school absenteeism (children) and work absenteeism (parents) recorded using the electronic patient-reported outcome (ePRO) diary, during each 12-week period
Time frame: week 36
Safety and tolerability of zoledronate, assessed by the incidence of adverse events and serious adverse events during the 36-week follow-up period
Time frame: week 36
Incremental cost-effectiveness ratio (ICER) of zoledronate versus placebo at week 36
Time frame: week 36
Proportion of participants achieving PedCNO50 response at week 36
Time frame: week 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Perrine DUSSER, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zoledronic Acid / Zoledronate 4 MG/100 ML Intravenous Solution and NaCL 0.9% Intravenous Solution in people with Osteomyelitis Chronic, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Perrine DUSSER, MD, PhD (+33145213254, perrine.dusser@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain score from baseline to week 12 (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.