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Trial record 4 of 32 for:    spinal cord injury | radiation

Denosumab Administration After Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT01983475
Recruitment Status : Unknown
Verified March 2019 by William A. Bauman, M.D., James J. Peters Veterans Affairs Medical Center.
Recruitment status was:  Recruiting
First Posted : November 14, 2013
Last Update Posted : March 8, 2019
Sponsor:
Collaborator:
Kessler Institute for Rehabilitation
Information provided by (Responsible Party):
William A. Bauman, M.D., James J. Peters Veterans Affairs Medical Center

Tracking Information
First Submitted Date  ICMJE November 6, 2013
First Posted Date  ICMJE November 14, 2013
Last Update Posted Date March 8, 2019
Study Start Date  ICMJE January 2015
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 6, 2013)
Dual Energy X-ray Absorptiometry [ Time Frame: Baseline, 1, 3, 6, 12, and 18 motnhs after Denosumab administration ]
Change in BMD at the distal femur from baseline to 18 months after Denosumab administration is the primary outcome measure.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2014)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2013)
Peripheral Quantitative Computerized Tomography (pQCT) [ Time Frame: Baseline, 12, and 18 months after Denosumab administration ]
A secondary outcome measure is to test the efficacy of Denosumab to prevent deterioration of the microarchitecture of trabecular bone at the distal femur, proximal tibia, and distal tibia as determined by peripheral pQCT
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Denosumab Administration After Spinal Cord Injury
Official Title  ICMJE The Efficacy of Denosumab to Reduce Osteoporosis After Spinal Cord Injury
Brief Summary Sublesional bone loss after acute spinal cord injury (SCI) is sudden, progressive, and dramatic. After depletion of bone mass and the loss of architectural integrity, it may be difficult, if even possible, to restore skeletal mass and strength. Denosumab is a relative new, highly potent anti-resorptive agent that has proven efficacy in postmenopausal osteoporosis to improve bone mass and in solid tumor patients to prevent a skeletal-related event to a greater extent than that with bisphosphonate administration. In persons with complete motor lesions, bisphosphonates have not been effective at reducing bone loss at the knee, the site of greatest relevance because of its increased risk of fracture. Anti-RANKL therapy appears to be more potent than bisphosphonates in animal models of bone loss due to immobilization, suggesting that treatment with denosumab may prove to be an efficacious therapy for persons with acute SCI to preserve bone mass and strength.
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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoporosis
  • Spinal Cord Injury
Intervention  ICMJE
  • Drug: Denosumab
    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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Placebo (identical Denosumab volume of normal saline)
  • Experimental: Denosumab
    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.
    Intervention: Drug: Denosumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 6, 2013)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Complete motor SCI [American Spinal Injury Association Impairment Scale (AIS) grade A and B];
  2. Duration of injury <12 weeks; and
  3. Males between the ages of 18 and 65 years old and females between the ages of 18 and 50 years old.

Exclusion Criteria:

  1. Extensive life-threatening injuries in addition to SCI;
  2. Acute fracture or extensive bone trauma;
  3. History of prior bone disease (Paget's hyperparathyroidism, osteoporosis, etc.)
  4. Post menopausal women;
  5. Men with known hypogonadism prior to SCI;
  6. Anabolic or Steroid hormonal therapy; within the past year and longer than six months;
  7. Hyperthyroidism;
  8. Cushing's disease or syndrome;
  9. Severe underlying chronic disease;
  10. Heterotopic ossification of the knee region (HO limited to the hip region only will not exclude subject participation);
  11. History of chronic alcohol abuse;
  12. Diagnosis of Hypocalcemia;
  13. Pregnancy;
  14. Existing dental condition/dental infection
  15. Any patient taking a bisphosphonate for heterotopic ossification (HO);
  16. Current diagnosis of cancer or history of cancer; and
  17. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01983475
Other Study ID Numbers  ICMJE 113536
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party William A. Bauman, M.D., James J. Peters Veterans Affairs Medical Center
Study Sponsor  ICMJE James J. Peters Veterans Affairs Medical Center
Collaborators  ICMJE Kessler Institute for Rehabilitation
Investigators  ICMJE
Principal Investigator: William A Bauman, M.D. James J. Peters VA Medical Center
Principal Investigator: Steven C Kirshblum, M.D. Kessler Institute for Rehabilitation
PRS Account James J. Peters Veterans Affairs Medical Center
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP