The Efficacy of Denosumab in Incomplete Patients Spinal Cord Injury
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ClinicalTrials.gov Identifier: NCT03029442 |
Recruitment Status :
Recruiting
First Posted : January 24, 2017
Last Update Posted : March 8, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Secondary Osteoporosis Spinal Cord Injury | Drug: Denosumab (Prolia) Other: Placebo (normal saline) | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 32 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | The Efficacy of Denosumab to Prevent Bone Loss in Ambulatory and Non-ambulatory Motor-Incomplete Patients With Subacute Spinal Cord Injury |
Actual Study Start Date : | April 1, 2017 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | December 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Denosumab, AIS Grade C (non-ambulatory)
8 subjects with AIS grade C will be randomized to receive Denosumab (Prolia 120mg SC) administered at baseline and 6 months.
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Drug: Denosumab (Prolia)
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).
Other Name: Xgeva |
Placebo Comparator: Placebo, AIS Grade C (non-ambulatory)
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.
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Other: Placebo (normal saline)
Identical Denosumab volume of normal saline |
Experimental: Denosumab, AIS Grade D (ambulatory)
8 subjects with AIS grade D will be randomized to receive Denosumab (Prolia 120mg SC) administered at baseline and 6 months.
|
Drug: Denosumab (Prolia)
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).
Other Name: Xgeva |
Placebo Comparator: Placebo, AIS Grade D (ambulatory)
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.
|
Other: Placebo (normal saline)
Identical Denosumab volume of normal saline |
- 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
- 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 ]Efficacy of denosumab to prevent vBMD loss and microarchitecture deterioration at the distal femur and proximal tibia

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03029442
Contact: Christopher M Cirnigliaro, M.S. | 973-731-3900 ext 2755 | christopher.cirnigliaro@va.gov | |
Contact: William A Bauman, M.D. | 718-584-9000 ext 5428 | william.bauman@va.gov |
United States, New Jersey | |
Kessler Institute for Rehabilitation | Not yet recruiting |
West Orange, New Jersey, United States, 07052 | |
Contact: Christopher M Cirnigliaro, M.S. 973-731-3900 ext 2755 christopher.cirnigliaro@gmail.com | |
Contact: Steven C Kirshblum, M.D. 973-731-3900 ext 2258 skirshblum@kessler-rehab.com | |
Sub-Investigator: Christopher M Cirniliaro, M.S. | |
Principal Investigator: Steven C Kirshblum, M.D. | |
United States, New York | |
James J. Peters VA Medical Center | Recruiting |
Bronx, New York, United States, 10468 | |
Contact: Joshua C Hobson, M.S. 718-584-9000 ext 3129 joshua.hobson@va.gov |
Principal Investigator: | William A Bauman, M.D. | James J. Peters VA Medical Center | |
Principal Investigator: | Steven C Kirshblum, M.D. | Kessler Institute for Rehabilitation |
Responsible Party: | William A. Bauman, M.D., Director, Clinical Investigator, National Center of Excellence for the Medical Consequences of Spinal Cord Injury, James J. Peters Veterans Affairs Medical Center |
ClinicalTrials.gov Identifier: | NCT03029442 |
Other Study ID Numbers: |
BAU-16-057 |
First Posted: | January 24, 2017 Key Record Dates |
Last Update Posted: | March 8, 2019 |
Last Verified: | March 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | An IPD is not desired by the investigators and is not part of the regulatory guidelines at the participating institutions |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Spinal Cord Injury Denosumab Osteoporosis Dual Energy X-ray Absorptiometry |
Osteoporosis Spinal Cord Injuries Wounds and Injuries Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System |
Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Metabolic Diseases Denosumab Bone Density Conservation Agents Physiological Effects of Drugs |