Osteoporosis FracturePhase 4NCT04597931
Evaluation of Romosozumab vs. Zoledronic Acid Effect in Patients With Spinal Cord Injury and Low Bone Mineral Density
A Phase 4 study testing Romosozumab and Zoledronic Acid in people with Osteoporosis Fracture and Spinal Cord Injuries, run by Sheba Medical Center.
Trial summary
This is a randomized study to determine the effects of monthly romosozumab for one year or one-time zoledronic acid on bone mineral density (BMD) and biochemical markers of bone formation and resorption, in patients with spinal cord injury (SCI) and low BMD. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Osteoporosis Fracture, Spinal Cord Injuries
- What is being tested?
- Romosozumab and Zoledronic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2020to 15 Nov 2023
- Phase
- Phase 4
- 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 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMD T-score ≤ -2.0 at the lumbar spine, total hip or femoral neck
- SCI of at least 24-month but less than 7 years duration,
- American Spinal Injury Association (ASIA) Impairment Scale A-C
Who cannot join
- myocardial infarction (MI) or stroke within the preceding year
- high cardiovascular risk, 10 years Framingham score over 20 %.
Trial locations and contacts
No sites are listed yet.
About this study
This is a randomized study to determine the effects of monthly romosozumab for one year or one-time zoledronic acid on bone mineral density (BMD) and biochemical markers of bone formation and resorption, in patients with spinal cord injury (SCI) and low BMD.
Read the detailed description
This is a randomized open-label study to determine the effects of monthly romosozumab for 12 month or one-time zoledronic acid infusion on bone mineral density (BMD) and biochemical markers of bone formation and resorption, in patients with spinal cord injury (SCI) and low BMD.
Patients: Thirty women between 20-70 years of age with spinal cord injury and low bone mass (BMD T-score lower than -2.0 in at least one location: Lumbar Spine, Femoral Neck or Total Hip sites) will receive study medication.
Primary outcome:
Total hip BMD change during a one-year treatment period.
Secondary outcome:
Change in Femoral neck BMD at 12 months, Bone turnover markers change over time (3, 9 and 12 month): C-terminal telopeptide of type I collagen (CTX), N-terminal propeptide of type I procollagen (P1NP).
Study population:
Thirty women between 20-70 years of age with spinal cord injury that occurred more than 24 month ago and low bone mass (BMD T-score lower than -2.0 in at least one location: Lumbar Spine, Femoral Neck or Total Hip sites)
- Conditions
- Osteoporosis Fracture, Spinal Cord Injuries
- Being tested
- Romosozumab, Zoledronic Acid
- Keywords
- bone mineral density, fracture, romosozumab
- Medical subject headings
- Osteoporotic Fractures, Spinal Cord Injuries, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RomosozumabDrug
SC Romosozumab 210 mg/monthly
Zoledronic AcidDrug
IV Zoledronic acid 5 mg
| Study group | Role | What they receive |
|---|---|---|
| SC Romosozumab 210 mg/monthly | Experimental | SC Romosozumab 210 mg/monthly Receives: Drug: Romosozumab |
| IV Zoledronic acid 5 mg | Active comparator | IV Zoledronic acid 5 mg Receives: Drug: Zoledronic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total hip BMD change during a one-year treatment period
BMD change
Measured: one year
Secondary outcomes (2)
Change in Femoral neck BMD at 12 months
BTM change
Measured: one year
Bone turnover markers change
Bone turnover markers change over time (3, 9 and 12 month)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Nov 2020 (estimated)
- Primary completion15 Nov 2023 (estimated)
- Study completion15 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis FractureStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- open label
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Liana Tripto Shkolnik, Sheba Medical Center
- Investigators
- Liana Tripto-Shkolnik, MD, Principal investigator, Sheba Medical Center, Tel Hashomer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597931
- Sponsor's protocol ID
- SHEBA-20-7186-LT-CTIL
- Status last verified
- Oct 2020
- First submitted
- 12 Oct 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Romosozumab vs. Zoledronic Acid Effect in Patients With Spinal Cord Injury and Low Bone Mineral Density
- ClinicalTrials.gov ID
- NCT04597931
- Acronym / sponsor ID
- SHEBA-20-7186-LT-CTIL
- Conditions
- Osteoporosis Fracture, Spinal Cord Injuries
- Keywords
- bone mineral density, fracture, romosozumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 15 Nov 2023 (estimated)
- Study completion
- 15 Nov 2023 (estimated)
- First posted
- 22 Oct 2020 (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.
This is a randomized study to determine the effects of monthly romosozumab for one year or one-time zoledronic acid on bone mineral density (BMD) and biochemical markers of bone formation and resorption, in patients with spinal cord injury (SCI) and low BMD.
Detailed description
This is a randomized open-label study to determine the effects of monthly romosozumab for 12 month or one-time zoledronic acid infusion on bone mineral density (BMD) and biochemical markers of bone formation and resorption, in patients with spinal cord injury (SCI) and low BMD.
Patients: Thirty women between 20-70 years of age with spinal cord injury and low bone mass (BMD T-score lower than -2.0 in at least one location: Lumbar Spine, Femoral Neck or Total Hip sites) will receive study medication.
Primary outcome:
Total hip BMD change during a one-year treatment period.
Secondary outcome:
Change in Femoral neck BMD at 12 months, Bone turnover markers change over time (3, 9 and 12 month): C-terminal telopeptide of type I collagen (CTX), N-terminal propeptide of type I procollagen (P1NP).
Study population:
Thirty women between 20-70 years of age with spinal cord injury that occurred more than 24 month ago and low bone mass (BMD T-score lower than -2.0 in at least one location: Lumbar Spine, Femoral Neck or Total Hip sites)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open label
| Arm | Type | Receives |
|---|---|---|
| SC Romosozumab 210 mg/monthly | Experimental | Drug: RomosozumabSC Romosozumab 210 mg/monthly |
| IV Zoledronic acid 5 mg | Active comparator | Drug: Zoledronic AcidIV Zoledronic acid 5 mg |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMD T-score ≤ -2.0 at the lumbar spine, total hip or femoral neck
- SCI of at least 24-month but less than 7 years duration,
- American Spinal Injury Association (ASIA) Impairment Scale A-C
Key exclusion criteria (2 listed)
- myocardial infarction (MI) or stroke within the preceding year
- high cardiovascular risk, 10 years Framingham score over 20 %.
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 |
|---|---|---|
| RomosozumabSC Romosozumab 210 mg/monthly | Drug | SC Romosozumab 210 mg/monthly |
| Zoledronic AcidIV Zoledronic acid 5 mg | Drug | IV Zoledronic acid 5 mg |
Primary outcome
Total hip BMD change during a one-year treatment period
Time frame: one year
BMD change
2 secondary outcomes
Change in Femoral neck BMD at 12 months
Time frame: one year
Bone turnover markers change
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- 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.
Liana Tripto-Shkolnik, MD principal investigator
Sheba Medical Center, Tel Hashomer
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Romosozumab and Zoledronic Acid in people with Osteoporosis Fracture and Spinal Cord Injuries, run by Sheba Medical Center.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liana Tripto-Shkolnik, MD (+972526334348, TriptoShkolnik.Liana@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total hip BMD change during a one-year treatment period (time frame: one year). 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 Oct 2020; AzTrials last refreshed its copy on 7 Nov 2026.