Metastatic Breast Cancer in the SpinePhase 2ZGMBCNCT05280067
ZETAMET™ BONE GRAFT IN THE REPAIR OF BONE DEFECTS FROM METASTATIC BREAST CANCER IN VERTEBRAL BONES
A Phase 2 study testing ZetaMet™ (ZetaFuse™ Bone Graft) in people with Metastatic Breast Cancer in the Spine, run by Zetagen Therapeutics, Inc at 2 sites in Canada.
Trial summary
ZetaMet™ is indicated for patients with destructive, lytic lesions due to metastatic breast cancer to bone, with or without involvement of other sites, with at least one metastatic lesion located in a vertebral body of the spine, and a Spinal Instability Neoplastic Score (SINS) ≥3 and ≤9. Read more about this study
- Who is it for?
- Ages 22 to 75 years, women only
- Conditions the study is for
- Metastatic Breast Cancer in the Spine
- What is being tested?
- ZetaMet™ (ZetaFuse™ Bone Graft)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Sep 2022to 10 Oct 2025
- 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 22 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 22 (inclusive) and 75 years (inclusive) at the time of enrollment.
- Life expectancy of 12 months or more.
- Female patient with histologically confirmed diagnosis of primary breast cancer.
- Metastatic breast cancer to bone, with or without involvement of other sites (patients with single metastasis qualify)
- At least one lytic metastatic lesion located in the vertebral body of the spine.
- Normal spinal alignment.
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- SINS ≥3 and ≤9.
- Signed and dated Informed Consent Form (ICF).
- Patient is willing and able to participate in required follow-up visits at the Investigational Site and to complete study procedures and questionnaires.
Who cannot join
- Vertebral body collapse.
- Spinal cord compression.
- Known allergy to Investigational Device materials.
- Using medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., chronic systemic steroids).
- Current tobacco smoker or stopped smoking in past 6 months.
- Uncontrolled diabetes mellitus, HbAIC cutoff.
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- An active systemic infection (e.g., hepatitis, acquired immunodeficiency syndrome (AIDS), AIDS-related complex (ARC).
- Currently participating in any investigational trial not related to this trial.
- Any other severe acute or chronic medical condition that may interfere with the interpretation of the trial results, in the judgment of the PI, which would make the patient inappropriate for entry into this trial.
- Pregnant or planning to become pregnant during the trial.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
McGill University Health Center
Montreal, Quebec, H3G1A4
Vancouver Coastal Health Research Institute
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: FEASIBILITY STUDY OF ZETAMET™ BONE GRAFT IN THE REPAIR OF BONE DEFECTS FROM METASTATIC BREAST CANCER IN THE SPINAL VERTEBRAL BODY: A PHASE 2A, MULTICENTER, OPEN-LABELED, SINGLE-ARM STUDY
ZetaMet™ is indicated for patients with destructive, lytic lesions due to metastatic breast cancer to bone, with or without involvement of other sites, with at least one metastatic lesion located in a vertebral body of the spine, and a Spinal Instability Neoplastic Score (SINS) ≥3 and ≤9. ZetaMet™ is percutaneously implanted into the bone defect created by the metastatic tumor in a spinal vertebral body. ZetaMet™ is only for implantation into the vertebral body.
Read the detailed description
This is an open-label single-arm study. Subjects (N=10) will be recruited from up to 4 Investigational Sites in Canada. Key inclusion criteria are metastatic breast cancer to bone with at least one lytic metastatic lesion located in a vertebral body of the spine and a SINS ≥3 and ≤9. ZetaMet™ will be percutaneously implanted into the vertebral body defect(s) created by the lytic metastatic tumor. Post-operative care will be per standard of care (SOC) at the Investigational Site. Subjects will be followed for 180 days post-treatment. If post-surgical radiation treatment is planned, it should not occur for at least 84 days post-surgery to allow for bone formation.
- Conditions
- Metastatic Breast Cancer in the Spine
- Being tested
- ZetaMet™ (ZetaFuse™ Bone Graft)
- Keywords
- Metastatic Breast Cancer, Bone Metastases, Spine Metastases, Vancouver, Metastatic Breast Cancer to Bone, X-radiation therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZetaMet™ (ZetaFuse™ Bone Graft)Combination product
ZetaMet™ (ZetaFuse™ Bone Graft) will be percutaneously implanted into the vertebral body defect(s) created by the lytic metastatic tumor.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Device ZetaMet™ | Experimental | ZetaMet™ is percutaneously implanted into the bone defect created by the metastatic tumor in a spinal vertebral body. ZetaMet™ is only for implantation into the vertebral body. Receives: Combination Product: ZetaMet™ (ZetaFuse™ Bone Graft) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Skeletal Related Events (SREs)
SREs include pathologic fracture, spinal cord compression, radiation therapy to bone, or surgical intervention.
Measured: Day 0 up to Day 180
Number of subjects with at least one adverse event (AE)
An AE is any unfavorable sign, symptom, or disease temporally associated with study participation, including the use of the Investigational Device and all study procedures. An AE may or may not be related to the use of the Investigational Device or a study procedure. AEs may include abnormal laboratory findings, radiologic events, medical complications, and changes from baseline in the subject's condition.
Measured: Day 0 up to Day 180
Number of subjects with at least one procedure-related AE
A procedure-related AE is any unfavorable sign, symptom, or disease temporally associated with any study procedure. These AEs may include abnormal laboratory findings, radiologic events, medical complications, and changes from baseline in the subject's condition, related to any study procedure.
Measured: Day 0 up to Day 180
Number of subjects with at least one device-related AE
A device-related AE is any unfavorable sign, symptom, or disease temporally associated with the Investigational Device. These AEs may include abnormal laboratory findings, radiologic events, medical complications, and changes from baseline in the subject's condition, related to the Investigational Device.
Measured: Day 0 up to Day 180
Change in SINS assessment at 21 days compared to baseline
The SINS is a scoring system based on six parameters; one for pain and five radiographic parameters (location, bone lesion quality, spinal alignment, vertebral body collapse and involvement of posterolateral elements). The SINS ranges 0-18. Score in range 0-6 denote stability; 7-12 intermediate instability and 13-18 instability.
Measured: Day 0 to Day 21 postoperatively
Change in SINS assessment at 42 days compared to baseline
The SINS is a scoring system based on six parameters; one for pain and five radiographic parameters (location, bone lesion quality, spinal alignment, vertebral body collapse and involvement of posterolateral elements). The SINS ranges 0-18. Score in range 0-6 denote stability; 7-12 intermediate instability and 13-18 instability.
Measured: Day 0 to Day 42 postoperatively
Change in SINS assessment at 84 days compared to baseline
The SINS is a scoring system based on six parameters; one for pain and five radiographic parameters (location, bone lesion quality, spinal alignment, vertebral body collapse and involvement of posterolateral elements). The SINS ranges 0-18. Score in range 0-6 denote stability; 7-12 intermediate instability and 13-18 instability.
Measured: Day 0 to Day 84 postoperatively
Change in SINS assessment at 180 days compared to baseline
The SINS is a scoring system based on six parameters; one for pain and five radiographic parameters (location, bone lesion quality, spinal alignment, vertebral body collapse and involvement of posterolateral elements). The SINS ranges 0-18. Score in range 0-6 denote stability; 7-12 intermediate instability and 13-18 instability.
Measured: Day 0 to Day 180 postoperatively
Change in Short Form 12v2 (SF-12v2) score compared to baseline
The 12-Item Short Form Survey version 2 (SF-12v2) is a shortened version of the SF-36v2 designed to reduce respondent burden while achieving minimum standards of precision for purposes of group comparisons involving multiple health dimensions. The SF-12v2 is given at baseline and at 180 days postoperatively.
Measured: Day 0 to Day 180 postoperatively
Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 21 days compared to baseline
The Numeric Rating Scale (NRS) is a psychometric response scale which is commonly used in questionnaires and studies to measure the intensity of pain. In this study we will use a 11-point (0-10) scale where "0" denotes no pain and "10" is the worst imaginable pain.
Measured: Day 0 to Day 21 postoperatively
Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 42 days compared to baseline
The Numeric Rating Scale (NRS) is a psychometric response scale which is commonly used in questionnaires and studies to measure the intensity of pain. In this study we will use a 11-point (0-10) scale where "0" denotes no pain and "10" is the worst imaginable pain.
Measured: Day 0 to Day 42 postoperatively
Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 84 days compared to baseline
The Numeric Rating Scale (NRS) is a psychometric response scale which is commonly used in questionnaires and studies to measure the intensity of pain. In this study we will use a 11-point (0-10) scale where "0" denotes no pain and "10" is the worst imaginable pain.
Measured: Day 0 to Day 84 postoperatively
Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 180 days compared to baseline
The Numeric Rating Scale (NRS) is a psychometric response scale which is commonly used in questionnaires and studies to measure the intensity of pain. In this study we will use a 11-point (0-10) scale where "0" denotes no pain and "10" is the worst imaginable pain.
Measured: Day 0 to Day 180 postoperatively
Change in vertebral body defect size measured by CT at 42 days compared to baseline
Vertebral body defect size measured by CT
Measured: Day 0 to Day 42 postoperatively
Change in vertebral body defect size measured by planar radiographs at 42 days compared to baseline
Vertebral body defect size and planar radiographs
Measured: Day 0 to Day 42 postoperatively
Change in vertebral body defect size measured by CT at 180 days compared to baseline
Vertebral body defect size measured by CT
Measured: Day 0 to Day 180 postoperatively
Change in vertebral body defect size measured by planar radiographs at 180 days compared to baseline
Vertebral body defect size measured by planar radiographs
Measured: Day 0 to Day 180 postoperatively
Duration of use of postoperative prescription opioid
The average per group duration of intake of opioids in the post-operative setting.
Measured: Day 180 postoperatively
Daily dose of postoperative prescription opioid use
The average per group dosage of opioids in the post-operative setting.
Measured: Day 180 postoperatively
Naloxone concentrations in blood collected from patients at 30 minutes following the vertebroplasty procedure
Two blood samples (5 mL each) of whole blood are collected at 30 minutes following the placement of the surgical bandage (n=2 blood collections of a total of 10 mL per patient). When naloxone blood concentrations remain below 1.016-ng/mL, there is not a reduction in opioid analgesia
Measured: 30 minutes following the placement of the surgical bandage
Naloxone concentrations in blood collected from patients at 60 minutes after the vertebroplasty procedure
Two blood samples (5 mL each) will be collected at 60 minutes following the placement of the surgical bandage (n=2 blood collections of a total of 10 mL per patient). When naloxone blood concentrations remain below 1.016-ng/mL, there is not a reduction in opioid analgesia
Measured: 60 minutes following the placement of the surgical bandage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start1 Sep 2022
- Primary completion10 Oct 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast Cancer in the SpineStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zetagen Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280067
- Sponsor's protocol ID
- ZG-2021-002
- Acronym
- ZGMBC
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2022
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FEASIBILITY STUDY OF ZETAMET™ BONE GRAFT IN THE REPAIR OF BONE DEFECTS FROM METASTATIC BREAST CANCER IN THE SPINAL VERTEBRAL BODY: A PHASE 2A, MULTICENTER, OPEN-LABELED, SINGLE-ARM STUDY
- ClinicalTrials.gov ID
- NCT05280067
- Acronym / sponsor ID
- ZGMBC / ZG-2021-002
- Conditions
- Metastatic Breast Cancer in the Spine
- Keywords
- Metastatic Breast Cancer, Bone Metastases, Spine Metastases, Vancouver, Metastatic Breast Cancer to Bone, X-radiation therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Zetagen Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 15 Mar 2022 (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.
ZetaMet™ is indicated for patients with destructive, lytic lesions due to metastatic breast cancer to bone, with or without involvement of other sites, with at least one metastatic lesion located in a vertebral body of the spine, and a Spinal Instability Neoplastic Score (SINS) ≥3 and ≤9. ZetaMet™ is percutaneously implanted into the bone defect created by the metastatic tumor in a spinal vertebral body. ZetaMet™ is only for implantation into the vertebral body.
Detailed description
This is an open-label single-arm study. Subjects (N=10) will be recruited from up to 4 Investigational Sites in Canada. Key inclusion criteria are metastatic breast cancer to bone with at least one lytic metastatic lesion located in a vertebral body of the spine and a SINS ≥3 and ≤9. ZetaMet™ will be percutaneously implanted into the vertebral body defect(s) created by the lytic metastatic tumor. Post-operative care will be per standard of care (SOC) at the Investigational Site. Subjects will be followed for 180 days post-treatment. If post-surgical radiation treatment is planned, it should not occur for at least 84 days post-surgery to allow for bone formation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational Device ZetaMet™ | Experimental | Combination Product: ZetaMet™ (ZetaFuse™ Bone Graft)ZetaMet™ is percutaneously implanted into the bone defect created by the metastatic tumor in a spinal vertebral body. ZetaMet™ is only for implantation into the vertebral body. |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age between 22 (inclusive) and 75 years (inclusive) at the time of enrollment.
- Life expectancy of 12 months or more.
- Female patient with histologically confirmed diagnosis of primary breast cancer.
- Metastatic breast cancer to bone, with or without involvement of other sites (patients with single metastasis qualify)
- At least one lytic metastatic lesion located in the vertebral body of the spine.
Key exclusion criteria (10 listed)
- Vertebral body collapse.
- Spinal cord compression.
- Known allergy to Investigational Device materials.
- Using medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., chronic systemic steroids).
- Current tobacco smoker or stopped smoking in past 6 months.
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 |
|---|---|---|
| ZetaMet™ (ZetaFuse™ Bone Graft)ZetaMet™ (ZetaFuse™ Bone Graft) will be percutaneously implanted into the vertebral body defect(s) created by the lytic metastatic tumor. | Combination product | Investigational Device ZetaMet™ |
Primary outcome
Number of Skeletal Related Events (SREs)
Time frame: Day 0 up to Day 180
SREs include pathologic fracture, spinal cord compression, radiation therapy to bone, or surgical intervention.
Number of subjects with at least one adverse event (AE)
Time frame: Day 0 up to Day 180
An AE is any unfavorable sign, symptom, or disease temporally associated with study participation, including the use of the Investigational Device and all study procedures. An AE may or may not be related to the use of the Investigational Device or a study procedure. AEs may include abnormal laboratory findings, radiologic events, medical complications, and changes from baseline in the subject's condition.
Number of subjects with at least one procedure-related AE
Time frame: Day 0 up to Day 180
A procedure-related AE is any unfavorable sign, symptom, or disease temporally associated with any study procedure. These AEs may include abnormal laboratory findings, radiologic events, medical complications, and changes from baseline in the subject's condition, related to any study procedure.
Number of subjects with at least one device-related AE
Time frame: Day 0 up to Day 180
A device-related AE is any unfavorable sign, symptom, or disease temporally associated with the Investigational Device. These AEs may include abnormal laboratory findings, radiologic events, medical complications, and changes from baseline in the subject's condition, related to the Investigational Device.
Change in SINS assessment at 21 days compared to baseline
Time frame: Day 0 to Day 21 postoperatively
The SINS is a scoring system based on six parameters; one for pain and five radiographic parameters (location, bone lesion quality, spinal alignment, vertebral body collapse and involvement of posterolateral elements). The SINS ranges 0-18. Score in range 0-6 denote stability; 7-12 intermediate instability and 13-18 instability.
Change in SINS assessment at 42 days compared to baseline
Time frame: Day 0 to Day 42 postoperatively
The SINS is a scoring system based on six parameters; one for pain and five radiographic parameters (location, bone lesion quality, spinal alignment, vertebral body collapse and involvement of posterolateral elements). The SINS ranges 0-18. Score in range 0-6 denote stability; 7-12 intermediate instability and 13-18 instability.
Change in SINS assessment at 84 days compared to baseline
Time frame: Day 0 to Day 84 postoperatively
The SINS is a scoring system based on six parameters; one for pain and five radiographic parameters (location, bone lesion quality, spinal alignment, vertebral body collapse and involvement of posterolateral elements). The SINS ranges 0-18. Score in range 0-6 denote stability; 7-12 intermediate instability and 13-18 instability.
Change in SINS assessment at 180 days compared to baseline
Time frame: Day 0 to Day 180 postoperatively
The SINS is a scoring system based on six parameters; one for pain and five radiographic parameters (location, bone lesion quality, spinal alignment, vertebral body collapse and involvement of posterolateral elements). The SINS ranges 0-18. Score in range 0-6 denote stability; 7-12 intermediate instability and 13-18 instability.
Change in Short Form 12v2 (SF-12v2) score compared to baseline
Time frame: Day 0 to Day 180 postoperatively
The 12-Item Short Form Survey version 2 (SF-12v2) is a shortened version of the SF-36v2 designed to reduce respondent burden while achieving minimum standards of precision for purposes of group comparisons involving multiple health dimensions. The SF-12v2 is given at baseline and at 180 days postoperatively.
Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 21 days compared to baseline
Time frame: Day 0 to Day 21 postoperatively
The Numeric Rating Scale (NRS) is a psychometric response scale which is commonly used in questionnaires and studies to measure the intensity of pain. In this study we will use a 11-point (0-10) scale where "0" denotes no pain and "10" is the worst imaginable pain.
Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 42 days compared to baseline
Time frame: Day 0 to Day 42 postoperatively
The Numeric Rating Scale (NRS) is a psychometric response scale which is commonly used in questionnaires and studies to measure the intensity of pain. In this study we will use a 11-point (0-10) scale where "0" denotes no pain and "10" is the worst imaginable pain.
Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 84 days compared to baseline
Time frame: Day 0 to Day 84 postoperatively
The Numeric Rating Scale (NRS) is a psychometric response scale which is commonly used in questionnaires and studies to measure the intensity of pain. In this study we will use a 11-point (0-10) scale where "0" denotes no pain and "10" is the worst imaginable pain.
Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 180 days compared to baseline
Time frame: Day 0 to Day 180 postoperatively
The Numeric Rating Scale (NRS) is a psychometric response scale which is commonly used in questionnaires and studies to measure the intensity of pain. In this study we will use a 11-point (0-10) scale where "0" denotes no pain and "10" is the worst imaginable pain.
Change in vertebral body defect size measured by CT at 42 days compared to baseline
Time frame: Day 0 to Day 42 postoperatively
Vertebral body defect size measured by CT
Change in vertebral body defect size measured by planar radiographs at 42 days compared to baseline
Time frame: Day 0 to Day 42 postoperatively
Vertebral body defect size and planar radiographs
Change in vertebral body defect size measured by CT at 180 days compared to baseline
Time frame: Day 0 to Day 180 postoperatively
Vertebral body defect size measured by CT
Change in vertebral body defect size measured by planar radiographs at 180 days compared to baseline
Time frame: Day 0 to Day 180 postoperatively
Vertebral body defect size measured by planar radiographs
Duration of use of postoperative prescription opioid
Time frame: Day 180 postoperatively
The average per group duration of intake of opioids in the post-operative setting.
Daily dose of postoperative prescription opioid use
Time frame: Day 180 postoperatively
The average per group dosage of opioids in the post-operative setting.
Naloxone concentrations in blood collected from patients at 30 minutes following the vertebroplasty procedure
Time frame: 30 minutes following the placement of the surgical bandage
Two blood samples (5 mL each) of whole blood are collected at 30 minutes following the placement of the surgical bandage (n=2 blood collections of a total of 10 mL per patient). When naloxone blood concentrations remain below 1.016-ng/mL, there is not a reduction in opioid analgesia
Naloxone concentrations in blood collected from patients at 60 minutes after the vertebroplasty procedure
Time frame: 60 minutes following the placement of the surgical bandage
Two blood samples (5 mL each) will be collected at 60 minutes following the placement of the surgical bandage (n=2 blood collections of a total of 10 mL per patient). When naloxone blood concentrations remain below 1.016-ng/mL, there is not a reduction in opioid analgesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ZetaMet™ (ZetaFuse™ Bone Graft) in people with Metastatic Breast Cancer in the Spine, run by Zetagen Therapeutics, Inc at 2 sites 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 9 inclusion and 10 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: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Skeletal Related Events (SREs) (time frame: Day 0 up to Day 180). The study lists 21 primary outcomes in all. 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 16 Jan 2026.