OsteoporosisPhase 2NCT02632903
Intravenous Zoledronic Acid for the Treatment of Osteoporosis and Osteonecrosis in Children With Leukemia: A Pilot Study
A Phase 2 study testing Zoledronic acid in people with Osteoporosis and Osteonecrosis, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
Trial summary
This study explores the effect of zoledronic acid on incident vertebral fractures and osteonecrotic lesions in children recently diagnosed with acute lymphoblastic leukemia. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Osteoporosis, Osteonecrosis, Acute Lymphoblastic Leukemia
- What is being tested?
- Zoledronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2016to 20 Aug 2018
- Phase
- Phase 2
- 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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject or subject's legally acceptable representative has provided informed consent.
- Children aged 8 to 16 years at the time of enrolment with a confirmed diagnosis of acute lymphoblastic leukemia (ALL).
- Children with vertebral fractures or osteonecrotic lesions according to the following criteria:
- children with vertebral fractures on lateral spine x-ray and/or osteonecrotic lesions on MRI of the hips and/or knees identified through routine clinical screening at least 8 weeks following chemotherapy initiation OR
- children with vertebral fractures on lateral spine x-ray and/or osteonecrotic lesions of the hips and/or knees on MRI that are identified at any time in the first 12 months after chemotherapy initiation following presentation with back pain (in the case of vertebral fractures, identified by lateral spine x-rays) and/or hip pain (in the case of osteonecrotic lesions, identified by MRI) and/or knee pain (in the case of osteonecrotic lesions, identified by MRI).
Who cannot join
- Any child for whom the treating physician feels participation is not advised.
- Prior treatment with an osteoporosis agent (e.g. bisphosphonate).
- Co-morbidities affecting musculoskeletal health (e.g. cerebral palsy).
- Children with renal failure (eGFR<60ml/min/1.73m2).
- Children with untreated vitamin D deficiency (vitamin D <50nmol/L).
- Children with hypocalcemia.
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- Children planning dental procedures and/or dental surgery during the course of the study.
- Children with asthma who are acetylsalicylic acid (ASA) sensitive.
- Children with a documented history of atrial fibrillation.
- Currently pregnant or planning a pregnancy during the study.
- Currently breastfeeding or planning on breastfeeding during the study.
Trial locations and contacts
1 site in 1 country.
About this study
This study explores the effect of zoledronic acid on incident vertebral fractures and osteonecrotic lesions in children recently diagnosed with acute lymphoblastic leukemia.
- Conditions
- Osteoporosis, Osteonecrosis, Acute Lymphoblastic Leukemia
- Being tested
- Zoledronic acid
- Medical subject headings
- Osteoporosis, Osteonecrosis, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic acidDrug
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Zoledronic Acid | Experimental | Intravenous Zoledronic Acid 0.025mg/kg at baseline and 6 months Receives: Drug: Zoledronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effect of zoledronic acid on preventing incident vertebral fractures
To assess the effect of zoledronic acid on preventing incident vertebral fractures as measured by lateral spine radiographs at 15 months post-diagnosis compared to baseline (with baseline occurring 3 months post-diagnosis). An incident vertebral fracture on lateral spine radiographs will be defined as a new fracture (Genant Grade 1 or more) in a previously normal vertebral body, or worsening of an existing fracture (increase in Genant Grade by at least 1) on the follow-up x-ray that takes place 12 months after the first dose.
Measured: 15 months post-diagnosis (12 months after baseline visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startOct 2016
- Primary completionMar 2018 (estimated)
- Study completion20 Aug 2018
Why it stopped: While the clinical need for and the scientific merit remain valid, this regulated drug trial was not feasible logistically due to limited funds.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Leanne Ward, Children's Hospital of Eastern Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632903
- Sponsor's protocol ID
- ZA8DEC2015
- Status last verified
- Aug 2018
- First submitted
- 15 Dec 2015
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Zoledronic Acid for the Treatment of Osteoporosis and Osteonecrosis in Children With Leukemia: A Pilot Study
- ClinicalTrials.gov ID
- NCT02632903
- Acronym / sponsor ID
- ZA8DEC2015
- Conditions
- Osteoporosis, Osteonecrosis, Acute Lymphoblastic Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: While the clinical need for and the scientific merit remain valid, this regulated drug trial was not feasible logistically due to limited funds.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- 20 Aug 2018 (actual)
- First posted
- 17 Dec 2015 (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.
This study explores the effect of zoledronic acid on incident vertebral fractures and osteonecrotic lesions in children recently diagnosed with acute lymphoblastic leukemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravenous Zoledronic Acid | Experimental | Drug: Zoledronic acidIntravenous Zoledronic Acid 0.025mg/kg at baseline and 6 months |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subject or subject's legally acceptable representative has provided informed consent.
- Children aged 8 to 16 years at the time of enrolment with a confirmed diagnosis of acute lymphoblastic leukemia (ALL).
- Children with vertebral fractures or osteonecrotic lesions according to the following criteria:
Key exclusion criteria (11 listed)
- Any child for whom the treating physician feels participation is not advised.
- Prior treatment with an osteoporosis agent (e.g. bisphosphonate).
- Co-morbidities affecting musculoskeletal health (e.g. cerebral palsy).
- Children with renal failure (eGFR<60ml/min/1.73m2).
- Children with untreated vitamin D deficiency (vitamin D <50nmol/L).
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 | Drug | Intravenous Zoledronic Acid |
Primary outcome
To assess the effect of zoledronic acid on preventing incident vertebral fractures
Time frame: 15 months post-diagnosis (12 months after baseline visit)
To assess the effect of zoledronic acid on preventing incident vertebral fractures as measured by lateral spine radiographs at 15 months post-diagnosis compared to baseline (with baseline occurring 3 months post-diagnosis). An incident vertebral fracture on lateral spine radiographs will be defined as a new fracture (Genant Grade 1 or more) in a previously normal vertebral body, or worsening of an existing fracture (increase in Genant Grade by at least 1) on the follow-up x-ray that takes place 12 months after the first dose.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Osteoporosis and Osteonecrosis, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
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 5 inclusion and 11 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: withdrawn, as of the sponsor's last update on 22 Aug 2018. 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 Canada. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
To assess the effect of zoledronic acid on preventing incident vertebral fractures (time frame: 15 months post-diagnosis (12 months after baseline visit)). 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 22 Aug 2018.