Bone Demineralization Lesions in the Injured MarrowPhase 3DBMZolNCT01802658
Bone Demineralization Lesions in the Injured Marrow: Efficacy and Tolerability of Administration Early and Repeated the Zoledronic Acid. Comparative Study, Prospective, Double-blind Controlled (DBMZol)
A Phase 3 study testing Zoledronic acid and NA Cl in people with Bone Demineralization Lesions in the Injured Marrow, run by Nantes University Hospital at 9 sites in France.
Trial summary
Subjects with lesion bone marrow are at risk of fracture by fragility bone. The median time to onset of fracture was 8.5 years. Fracture increases costs of care, dependency. Bone fragility is secondary to hormonal disorders and calcium phosphate, impaired excretion of neuropeptides, vasomotor symptoms associated with… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Bone Demineralization Lesions in the Injured Marrow
- What is being tested?
- Zoledronic acid and NA Cl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 9 sitesFrance
- Study dates
- Nov 2012to Dec 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Being diagnosed with a spinal cord injury less than 12 weeks of etiology stable,
- level of injury C5 L2,
- AIS grade A to D.
- Female or male between 18 and 45 years.
- No pregnancy.
- No osteoporosis.
Show all 10Show fewer
- Good oral health.
- Good glomerular filtration.
- No cons-indication to Zoledronic Acid.
- No drugs affecting bone metabolism
Who cannot join
- pregnancy.
- osteoporosis.
- cons-indication to Zoledronic Acid.
- drugs affecting bone metabolism
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Centre Bouffard - Vercelli CAP Cerbère
Cervera de la Marenda
CRMPR Les Herbiers
Les Herbiers
Centre Mutualiste Neurologique Propara
Montpellier
Institut Régional de Réadaptation Nancy
Nancy
University hospital of Nantes
Nantes, 44000
Hôpital R. Poincaré
Paris
CHU
Saint-Etienne
Centre de l'Arche
Saint-Saturnin
Hôpital Rangueil CHU
Toulouse
About this study
Official title: Bone Demineralization Lesions in the Injured Marrow: Efficacy and Tolerability of Administration Early and Repeated the Zoledronic Acid. Comparative Study, Prospective, Double-blind Controlled
Subjects with lesion bone marrow are at risk of fracture by fragility bone. The median time to onset of fracture was 8.5 years. Fracture increases costs of care, dependency.
Bone fragility is secondary to hormonal disorders and calcium phosphate, impaired excretion of neuropeptides, vasomotor symptoms associated with the asset that promote bone loss and architectural disorganization. These phenomena occur in the first weeks of development of spinal cord injury and predominate in the distal femur and proximal tibia. From the third year, the demineralization stabilizes, bone mass is estimated to be between 70 and 50% of the initial bone mass, the new equilibrium.
No clinical evidence is predictive of fracture risk. A criteria surrogate must be used to assess this risk. There is an association between bone mineral density and fracture risk. The fracture threshold knee was evaluated to 0.87 g/cm2. Evaluation of bone mineral density in the distal femur is a predictor of fracture risk. Measure reliable and reproducible, easy to perform, it is a good element for monitoring the efficacy of anti-resorptive therapy.
- Being tested
- Zoledronic acid, NA Cl
- Keywords
- Bone marrow demineralization lesions,: efficacy and tolerability, zoledronic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic acidDrug
Zoledronic acid 5 mg. IV. 3 infusions. Administration 3 times inclusion M12 and M24 over two years.
NA ClDrug
NACl 100 ml IV. 3 infusions. Administration 3 times inclusion M12, M24 over two years.
| Study group | Role | What they receive |
|---|---|---|
| Zoledronic acid | Active comparator | Zoledronic acid 5 mg. IV. 3 infusions. Administration 3 times over two years. Receives: Drug: Zoledronic acid |
| NACL | Placebo comparator | NACl 100 ml IV. 3 infusions. Administration 3 times over two years. Receives: Drug: NA Cl |
What is being measured
The primary outcome is the main question the study is designed to answer.
determine DMO distal femur at 36 months
Measured: october 2015
Secondary outcomes (4)
Incidence of fractures of members lower in the first 36 months.
to determine incidence of fractures of members lower in the first 36 months
Measured: october 2015
Response to the EQ-5D questionnaire at baseline, M12, M24, M36.
To determine the EQ-5D
Measured: october 2015
DMO (g/cm2) at the distal femur, proximal femur, spine, total body M6, M12, M24, M36.
Determine the DMO
Measured: october 2015
Bioassays: b CTX, PAO, PINP at M6, M12, M24, M36
to measure bioassays
Measured: october 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startNov 2012
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: Recruiting Difficulty
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Demineralization Lesions in the Injured MarrowStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01802658
- Sponsor's protocol ID
- BRD/11/06-P
- Other IDs
- 2012-001778-27
- Acronym
- DBMZol
- Status last verified
- Feb 2018
- First submitted
- 28 Feb 2013
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Demineralization Lesions in the Injured Marrow: Efficacy and Tolerability of Administration Early and Repeated the Zoledronic Acid. Comparative Study, Prospective, Double-blind Controlled
- ClinicalTrials.gov ID
- NCT01802658
- Acronym / sponsor ID
- DBMZol / BRD/11/06-P
- Keywords
- Bone marrow demineralization lesions,: efficacy and tolerability, zoledronic acid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruiting Difficulty
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Nov 2012 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 1 Mar 2013 (estimated)
- 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.
Subjects with lesion bone marrow are at risk of fracture by fragility bone. The median time to onset of fracture was 8.5 years. Fracture increases costs of care, dependency.
Bone fragility is secondary to hormonal disorders and calcium phosphate, impaired excretion of neuropeptides, vasomotor symptoms associated with the asset that promote bone loss and architectural disorganization. These phenomena occur in the first weeks of development of spinal cord injury and predominate in the distal femur and proximal tibia. From the third year, the demineralization stabilizes, bone mass is estimated to be between 70 and 50% of the initial bone mass, the new equilibrium.
No clinical evidence is predictive of fracture risk. A criteria surrogate must be used to assess this risk. There is an association between bone mineral density and fracture risk. The fracture threshold knee was evaluated to 0.87 g/cm2. Evaluation of bone mineral density in the distal femur is a predictor of fracture risk. Measure reliable and reproducible, easy to perform, it is a good element for monitoring the efficacy of anti-resorptive therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zoledronic acid | Active comparator | Drug: Zoledronic acidZoledronic acid 5 mg. IV. 3 infusions. Administration 3 times over two years. |
| NACL | Placebo comparator | Drug: NA ClNACl 100 ml IV. 3 infusions. Administration 3 times over two years. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Being diagnosed with a spinal cord injury less than 12 weeks of etiology stable,
- level of injury C5 L2,
- AIS grade A to D.
- Female or male between 18 and 45 years.
- No pregnancy.
Key exclusion criteria (4 listed)
- pregnancy.
- osteoporosis.
- cons-indication to Zoledronic Acid.
- drugs affecting bone metabolism
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 acidZoledronic acid 5 mg. IV. 3 infusions. Administration 3 times inclusion M12 and M24 over two years. | Drug | Zoledronic acid |
| NA ClNACl 100 ml IV. 3 infusions. Administration 3 times inclusion M12, M24 over two years. | Drug | NACL |
Primary outcome
determine DMO distal femur at 36 months
Time frame: october 2015
4 secondary outcomes
Incidence of fractures of members lower in the first 36 months.
Time frame: october 2015
Response to the EQ-5D questionnaire at baseline, M12, M24, M36.
Time frame: october 2015
DMO (g/cm2) at the distal femur, proximal femur, spine, total body M6, M12, M24, M36.
Time frame: october 2015
Bioassays: b CTX, PAO, PINP at M6, M12, M24, M36
Time frame: october 2015
Results and safety
The study was stopped early (reason given: Recruiting Difficulty). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zoledronic acid and NA Cl in people with Bone Demineralization Lesions in the Injured Marrow, run by Nantes University Hospital at 9 sites 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 10 inclusion and 4 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: stopped early, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruiting Difficulty). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
determine DMO distal femur at 36 months (time frame: october 2015). 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 28 Feb 2018.