Denosumab Administration After Spinal Cord Injury
|Osteoporosis Spinal Cord Injury||Drug: Denosumab Drug: Placebo (identical Denosumab volume of normal saline)||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Efficacy of Denosumab to Reduce Osteoporosis After Spinal Cord Injury|
- Bone mineral density (BMD) of the distal femur [ Time Frame: Baseline, 1, 3, 6, 12, and 18 months after Denosumab administration ]Change in BMD at the distal femur will be obtained by dual energy X-ray absorptiometry (DXA) at baseline, 1, 3, 6, 12, and 18 months after Denosumab administration.
- Bone microarchitecture of the distal femur and proximal tibia. [ Time Frame: Baseline, 12, and 18 months after Denosumab administration ]Change in microarchitecture at the distal femur and proximal tibia will be obtained by peripheral quantitative computerized tomography (pQCT) at baseline, 12, and 18 months after Denosumab administration.
|Study Start Date:||January 2015|
|Estimated Study Completion Date:||May 2018|
|Estimated Primary Completion Date:||May 2017 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
A group of participants will be randomized to the placebo group and will receive the identical volume of normal saline at parallel time points.
Drug: Placebo (identical Denosumab volume of normal saline)
The placebo group will receive the identical volume of normal saline at parallel time points.
Other Name: Unknown at this time
A group of participants will be randomized to the experimental group and will have Denosumab (Prolia, 60 mg SC) administered at baseline, 6 and 12 months.
In clinical trials, denosumab (Amgen Inc., Thousand Oaks, CA), has been shown to be more potent in reducing osteoclastosis and function than bisphosphonates.39,40 The rate of bone loss in the lower extremity at sites of interest in patients with acute SCI has been reported to be several-fold greater than the rate of bone loss in postmenopausal women not prescribed antiresorptive medications, which is about 3-5% per year.11,50,51 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: Prolia
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 acute SCI. Setting: patient enrollment, study drug administration and DXA scanning will be completed at the Kessler Institute for Rehabilitation (KIR) and pQCT measurements will be performed at Columbia University. A Randomized, double-blind, placebo-controlled parallel group trial.
Twenty-four subjects with acute, motor complete SCI (≤12 weeks) who have been admitted to the Kessler Institute for Rehabilitation (KIR) will be recruited for participation. The age of study participation will be males between the ages of 18 and 65 years old and females between the ages of 18 and 50 years old. Primary outcome measure will be BMD as measured by DXA and microarchitecture as measured by pQCT at the hip and knee.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01983475
|Contact: Christopher M Cirnigliaro, M.S.||973-731-3900 ext firstname.lastname@example.org|
|Contact: William A Bauman, M.D.||718-584-9000 ext email@example.com|
|United States, New Jersey|
|Kessler Institute for Rehabilitation||Recruiting|
|West Orange, New Jersey, United States, 07052|
|Contact: Christopher M Cirnigliaro, M.S. 973-731-3900 ext 2755 firstname.lastname@example.org|
|Contact: Steven C Kirshblum, M.D. 973-731-3900 ext 2258 email@example.com|
|Sub-Investigator: Christopher M Cirnigliaro, 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, MS 718-584-9000 ext 3129 firstname.lastname@example.org|
|Contact: Pierre Asselin, MS 718-584-9000 ext 3124 email@example.com|
|Principal Investigator:||William A Bauman, M.D.||James J. Peters VA Medical Center|
|Principal Investigator:||Steven C Kirshblum, M.D.||Kessler Institute for Rehabilitation|