Secondary OsteoporosisPhase 4NCT03029442
The Efficacy of Denosumab in Incomplete Patients Spinal Cord Injury
A Phase 4 study testing Denosumab (Prolia) in people with Secondary Osteoporosis and Spinal Cord Injury, run by James J. Peters Veterans Affairs Medical Center at 2 sites in United States.
Trial summary
The purpose of this study is to determine the usefulness of a drug, denosumab, to prevent the loss of bone in participants legs due to SCI. This drug is FDA approved to treat osteoporosis in women after menopause who have an increased risk for fractures, to treat women receiving certain treatments for breast cancer… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Secondary Osteoporosis, Spinal Cord Injury
- What is being tested?
- Denosumab (Prolia)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2017to 6 Oct 2022
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Motor incomplete SCI [American Spinal Injury Association Impairment Scale (AIS) grades C and D];
- Duration of injury < 6-months; and
- Males between the ages of 18 and 65 years old and females between the ages of 18 and 50 years old.
Who cannot join
- Extensive life-threatening injuries in addition to SCI;
- Acute fracture or extensive bone trauma;
- History of prior bone disease (Paget's hyperparathyroidism, osteoporosis, etc.)
- Post-menopausal women;
- Men with known hypogonadism prior to SCI;
- Anabolic or Steroid hormonal therapy; within the past year and longer than six months;
Show all 16Show fewer
- Hyperthyroidism;
- Cushing's disease or syndrome;
- Severe underlying chronic disease;
- History of chronic alcohol abuse;
- Diagnosis of Hypocalcemia;
- Pregnancy;
- Existing dental condition/dental infection;
- Diagnosis of heterotopic ossification at the hip and/or knee region and receiving a bisphosphonates [e.g. alendronate sodium (Fosamax) or etidronate disodium (Didronel)] that will no longer make participants eligible to receive the study medication/placebo but are still eligible to complete follow-up outcome measures as described in the work schedule;
- Current diagnosis of cancer or history of cancer; and
- Any patient receiving moderate or high dose corticosteroids (>40 mg/d prednisone or an equivalent dose of other corticosteroid) for longer than one week, not including drug administered in an attempt to preserve neurological function at the time of acute SCI.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
James J. Peters VA Medical Center
The Bronx, New York, 10468
Kessler Institute for Rehabilitation
West Orange, New Jersey, 07052
About this study
Official title: The Efficacy of Denosumab to Prevent Bone Loss in Ambulatory and Non-ambulatory Motor-Incomplete Patients With Subacute Spinal Cord Injury
The purpose of this study is to determine the usefulness of a drug, denosumab, to prevent the loss of bone in participants legs due to SCI. This drug is FDA approved to treat osteoporosis in women after menopause who have an increased risk for fractures, to treat women receiving certain treatments for breast cancer who have an increased risk of fractures, and to treat bone loss in men receiving certain treatments for prostate cancer who have increased risk for fractures. This drug is considered experimental for the purpose of this study. Study participation will last for approximately 12 months (6 study visits total), visits will range from1-4.5 hours depending on the number of tests that need to be completed. The study is a double-blinded placebo trail in which the participant will be randomly assigned to on of two groups, Denosumab injections or placebo - inactive salt solution injections.
Read the detailed description
The primary objective of this study is to test the efficacy of a potent anti-resorptive agent, denosumab [receptor activator of nuclear factor-κB ligand (RANKL) antibody; Amgen Inc.] to preserve bone mass at the hip and knee and trabecular connectivity at the knee after subacute motor-incomplete SCI [American Spinal Injury Association (AIS) neurological classification scale C and D] at the James J. Peters VA Medical Center (JJPVAMC) and Kessler Institute for Rehabilitation (KIR). A randomized, double-blind, placebo-controlled, parallel group trial will be performed in thirty-two subjects with acute, motor-incomplete SCI (≤6 months) who have been admitted to JJPVAMC or the KIR. Denosumab (60 mg SC) will be administered at baseline, 6, and 12 months; the placebo group will receive normal saline subcutaneously. Denosumab will be administered as soon as possible, but up to 24 weeks, after SCI. The last dose of denosumab and placebo will be administered at 6 months, with the anticipated effect of the drug to persist and inhibit bone resorption at least until the 12 month time point.
- Conditions
- Secondary Osteoporosis, Spinal Cord Injury
- Being tested
- Denosumab (Prolia), Placebo (normal saline)
- Keywords
- Spinal Cord Injury, Denosumab, Osteoporosis, Dual Energy X-ray Absorptiometry
- Medical subject headings
- Spinal Cord Injuries, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denosumab (Prolia)Drug
Also called Xgeva
In clinical trials, denosumab (Amgen Inc., Thousand Oaks, CA), has been shown to be more potent in reducing osteoclastosis and function than bisphosphonates. The dose of denosumab chosen for our protocol in patients after acute SCI will be the same dose that has been shown to be efficacious to treat postmenopausal osteoporosis (60 mg SQ q 6 months).
Placebo (normal saline)Other
Identical Denosumab volume of normal saline
| Study group | Role | What they receive |
|---|---|---|
| Denosumab, AIS Grade C (non-ambulatory) | Experimental | 8 subjects with AIS grade C will be randomized to receive Denosumab (Prolia 120mg SC) administered at baseline and 6 months. Receives: Drug: Denosumab (Prolia) |
| Placebo, AIS Grade C (non-ambulatory) | Placebo comparator | 8 subjects with AIS grade C will be randomized to the placebo group and will receive the identical volume of normal saline at parallel time points. Receives: Other: Placebo (normal saline) |
| Denosumab, AIS Grade D (ambulatory) | Experimental | 8 subjects with AIS grade D will be randomized to receive Denosumab (Prolia 120mg SC) administered at baseline and 6 months. Receives: Drug: Denosumab (Prolia) |
| Placebo, AIS Grade D (ambulatory) | Placebo comparator | 8 subjects with AIS grade D will be randomized to the placebo group and will receive the identical volume of normal saline at parallel time points. Receives: Other: Placebo (normal saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
areal bone mineral density (aBMD) by dual energy X-ray absorptiometry (DXA)
Efficacy of denosumab to prevent aBMD loss at the distal femur and proximal tibia
Measured: Prior to denosumab or placebo administration and 18 months after denosumab or placebo administration
Secondary outcomes (1)
volumetric BMD (vBMD) and microarchitecture by peripheral quantitative computed tomography
Efficacy of denosumab to prevent vBMD loss and microarchitecture deterioration at the distal femur and proximal tibia
Measured: Prior to denosumab or placebo administration and 12 months after denosumab or placebo administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study start1 Apr 2017
- Primary completion31 Dec 2021
- Study completion6 Oct 2022
Why it stopped: Study ended early due to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Secondary 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- James J. Peters Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Kessler Institute for Rehabilitation
- Responsible party
- Principal investigator, William A. Bauman, M.D., James J. Peters Veterans Affairs Medical Center
- Investigators
- William A Bauman, M.D., Principal investigator, James J. Peters VA Medical CenterSteven C Kirshblum, M.D., Principal investigator, Kessler Institute for Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029442
- Sponsor's protocol ID
- BAU-16-057
- Status last verified
- Mar 2024
- First submitted
- 20 Jan 2017
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: An IPD is not desired by the investigators and is not part of the regulatory guidelines at the participating institutions
Publications
Gifre L, Vidal J, Carrasco JL, Muxi A, Portell E, Monegal A, Guanabens N, Peris P. Denosumab increases sublesional bone mass in osteoporotic individuals with recent spinal cord injury. Osteoporos Int. 2016 Jan;27(1):405-10. doi: 10.1007/s00198-015-3333-5. Epub 2015 Sep 30.
PubMed 26423406
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Denosumab to Prevent Bone Loss in Ambulatory and Non-ambulatory Motor-Incomplete Patients With Subacute Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03029442
- Acronym / sponsor ID
- BAU-16-057
- Conditions
- Secondary Osteoporosis, Spinal Cord Injury
- Keywords
- Spinal Cord Injury, Denosumab, Osteoporosis, Dual Energy X-ray Absorptiometry
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study ended early due to COVID-19
- Enrolment
- 5 participants (actual)
- Lead sponsor
- James J. Peters Veterans Affairs Medical CenterUS federal agency
- Collaborators
- Kessler Institute for Rehabilitation
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 6 Oct 2022 (actual)
- First posted
- 24 Jan 2017 (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.
The purpose of this study is to determine the usefulness of a drug, denosumab, to prevent the loss of bone in participants legs due to SCI. This drug is FDA approved to treat osteoporosis in women after menopause who have an increased risk for fractures, to treat women receiving certain treatments for breast cancer who have an increased risk of fractures, and to treat bone loss in men receiving certain treatments for prostate cancer who have increased risk for fractures. This drug is considered experimental for the purpose of this study. Study participation will last for approximately 12 months (6 study visits total), visits will range from1-4.5 hours depending on the number of tests that need to be completed. The study is a double-blinded placebo trail in which the participant will be randomly assigned to on of two groups, Denosumab injections or placebo - inactive salt solution injections.
Detailed description
The primary objective of this study is to test the efficacy of a potent anti-resorptive agent, denosumab [receptor activator of nuclear factor-κB ligand (RANKL) antibody; Amgen Inc.] to preserve bone mass at the hip and knee and trabecular connectivity at the knee after subacute motor-incomplete SCI [American Spinal Injury Association (AIS) neurological classification scale C and D] at the James J. Peters VA Medical Center (JJPVAMC) and Kessler Institute for Rehabilitation (KIR). A randomized, double-blind, placebo-controlled, parallel group trial will be performed in thirty-two subjects with acute, motor-incomplete SCI (≤6 months) who have been admitted to JJPVAMC or the KIR. Denosumab (60 mg SC) will be administered at baseline, 6, and 12 months; the placebo group will receive normal saline subcutaneously. Denosumab will be administered as soon as possible, but up to 24 weeks, after SCI. The last dose of denosumab and placebo will be administered at 6 months, with the anticipated effect of the drug to persist and inhibit bone resorption at least until the 12 month time point.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Denosumab, AIS Grade C (non-ambulatory) | Experimental | Drug: Denosumab (Prolia)8 subjects with AIS grade C will be randomized to receive Denosumab (Prolia 120mg SC) administered at baseline and 6 months. |
| Placebo, AIS Grade C (non-ambulatory) | Placebo comparator | Other: Placebo (normal saline)8 subjects with AIS grade C will be randomized to the placebo group and will receive the identical volume of normal saline at parallel time points. |
| Denosumab, AIS Grade D (ambulatory) | Experimental | Drug: Denosumab (Prolia)8 subjects with AIS grade D will be randomized to receive Denosumab (Prolia 120mg SC) administered at baseline and 6 months. |
| Placebo, AIS Grade D (ambulatory) | Placebo comparator | Other: Placebo (normal saline)8 subjects with AIS grade D will be randomized to the placebo group and will receive the identical volume of normal saline at parallel time points. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Motor incomplete SCI [American Spinal Injury Association Impairment Scale (AIS) grades C and D];
- Duration of injury < 6-months; and
- Males between the ages of 18 and 65 years old and females between the ages of 18 and 50 years old.
Key exclusion criteria (16 listed)
- Extensive life-threatening injuries in addition to SCI;
- Acute fracture or extensive bone trauma;
- History of prior bone disease (Paget's hyperparathyroidism, osteoporosis, etc.)
- Post-menopausal women;
- Men with known hypogonadism prior to SCI;
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 |
|---|---|---|
| Denosumab (Prolia)Also: XgevaIn clinical trials, denosumab (Amgen Inc., Thousand Oaks, CA), has been shown to be more potent in reducing osteoclastosis and function than bisphosphonates. The dose of denosumab chosen for our protocol in patients after acute SCI will be the same dose that has been shown to be efficacious to treat postmenopausal osteoporosis (60 mg SQ q 6 months). | Drug | Denosumab, AIS Grade C (non-ambulatory), Denosumab, AIS Grade D (ambulatory) |
| Placebo (normal saline)Identical Denosumab volume of normal saline | Other | Placebo, AIS Grade C (non-ambulatory), Placebo, AIS Grade D (ambulatory) |
Primary outcome
areal bone mineral density (aBMD) by dual energy X-ray absorptiometry (DXA)
Time frame: Prior to denosumab or placebo administration and 18 months after denosumab or placebo administration
Efficacy of denosumab to prevent aBMD loss at the distal femur and proximal tibia
1 secondary outcome
volumetric BMD (vBMD) and microarchitecture by peripheral quantitative computed tomography
Time frame: Prior to denosumab or placebo administration and 12 months after denosumab or placebo administration
Results and safety
The study was stopped early (reason given: Study ended early due to COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Background: PubMed 26423406Gifre L, Vidal J, Carrasco JL, Muxi A, Portell E, Monegal A, Guanabens N, Peris P. Denosumab increases sublesional bone mass in osteoporotic individuals with recent spinal cord injury. Osteoporos Int. 2016 Jan;27(1):405-10. doi: 10.1007/s00198-015-3333-5. Epub 2015 Sep 30.
- Individual participant dataSharing planned: No. An IPD is not desired by the investigators and is not part of the regulatory guidelines at the participating institutions
Related trials for Secondary Osteoporosis
Not yet recruitingObservational study
Osteoporosis & Renal Disease: Research in Primary Health Care Services
Osteoporosis, Chronic Kidney Disease Mineral and Bone Disorder
RecruitingPhase 2
A Study of Romosozumab in People With Breast Cancer and Osteoporosis
Breast Cancer, Metastatic Breast Cancer (MBC)
Recruiting
RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures
Fragility Fracture, Hip Fractures
RecruitingObservational study
Deep Learning for Musculoskeletal Complications in Breast Cancer
Postmastectomy Lymphedema Syndrome, Breast Cancer Surgery Pain
Not yet recruiting
The Effect of Exoskeletal-assisted Walking Combined With Transcutaneous Spinal Cord Stimulation on Bone Strength.
Secondary Osteoporosis, Sarcopenia
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.
William A Bauman, M.D. principal investigator
James J. Peters VA Medical Center
Steven C Kirshblum, M.D. principal investigator
Kessler Institute for Rehabilitation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Denosumab (Prolia) in people with Secondary Osteoporosis and Spinal Cord Injury, run by James J. Peters Veterans Affairs Medical Center at 2 sites in United States.
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 16 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 15 Mar 2024. 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 United States. 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 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?
The study was stopped early (reason given: Study ended early due to COVID-19). 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?
areal bone mineral density (aBMD) by dual energy X-ray absorptiometry (DXA) (time frame: Prior to denosumab or placebo administration and 18 months after denosumab or placebo administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03029442, which also lists 1 linked publication.
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 15 Mar 2024.