We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment With Romosozumab Versus Denosumab to Improve Bone Mineral Density and Architecture in Subacute SCI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05101018
Recruitment Status : Recruiting
First Posted : October 29, 2021
Last Update Posted : December 20, 2021
Sponsor:
Collaborator:
Kessler Institute for Rehabilitation
Information provided by (Responsible Party):
William A. Bauman, M.D., James J. Peters Veterans Affairs Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The objective of the proposed work is to determine whether administration for 12 months of romosozumab followed by 12 months of denosumab will maintain bone mass at the knee in subjects with subacute SCI compared to 24 months of denosumab administration alone.

Condition or disease Intervention/treatment Phase
Osteoporosis Spinal Cord Injuries Drug: Romosozumab Drug: Denosumab Phase 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Arm 1: romosozumab administered monthly from baseline to month 11 followed by denosumab at month 12 and 18.

Arm 2: denosumab administered at baseline, month 6, 12, and 18
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Treatment With Romosozumab Versus Denosumab to Improve Bone Mineral Density and Architecture in Subacute SCI
Actual Study Start Date : November 1, 2021
Estimated Primary Completion Date : November 1, 2025
Estimated Study Completion Date : November 1, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Romosozumab Baseline to Month 11 followed by Denosumab Month 12 to Month 24

Of the forty (40) individuals with subacute spinal cord injury (SCI) enrolled in this study, twenty (20) participants will be randomly selected to receive romosozumab (210mg SQ) once a month for 12 months.

After 12 months the same twenty (20) individuals will receive denosumab (60mg SQ) at month 12 and 18.

 Drug: Romosozumab
Romosozumab (Amgen Inc., Thousand Oaks, CA) 210mg SQ administered each month
Other Name: Evenity

Drug: Denosumab
Denosumab (Amgen Inc., Thousand Oaks, CA) 60 mg SQ administered every six months
Other Name: Prolia
Active Comparator: Denosumab Baseline to Month 24
Of the forty (40) individuals with subacute spinal cord injury (SCI) enrolled in this study, twenty (20) participants will be randomly selected to receive denosumab (60 mg SQ) at baseline and 6, 12, and 18 months.
 Drug: Denosumab
Denosumab (Amgen Inc., Thousand Oaks, CA) 60 mg SQ administered every six months
Other Name: Prolia


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Bone mineral density (BMD) of the distal femur metaphysis [ Time Frame: Baseline to 24 months ]
    BMD at the distal femur metaphysis will be obtained by dual energy X-ray absorptiometry (DXA)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Traumatic motor-complete SCI C4-L2 (AIS grade A & B);
  2. Duration of SCI less than 6 months;
  3. Males and females (premenopausal) between the ages of 18 and 50 years old; and a safe range of BMD right above the knee as determined by study staff review;

Exclusion Criteria:

  1. Active and/or history of coronary heart disease or stroke;
  2. Bone cancer;
  3. Long-bone fracture of the leg within the past year;
  4. History of prior bone disease (for example, Paget's hyperparathyroidism, osteoporosis, etc.);
  5. Postmenopausal women;
  6. Men with known low functioning tests before SCI;
  7. Drugs geared toward increasing BMD longer than a six month duration after SCI;
  8. As determined by study staff review of my medication history of glucocorticoid administration longer than three months duration within the last year
  9. Abnormalities of my endocrine glands such as hyperthyroidism, Cushing's disease or syndrome, etc.;
  10. Severe underlying chronic disease (for example chronic obstructive pulmonary disease (COPD), end-stage heart disease, chronic renal failure);
  11. Heterotopic ossification (HO) of the distal femur (the knee end of the thigh bone). HO is a condition where bone tissue forms outside of the skeleton. If HO is found in any other area than the distal femur it will not prevent my participation in the study.;
  12. History of chronic alcohol abuse;
  13. Diagnosis of hypercalcemia (high levels of calcium in the blood);
  14. Pregnancy;
  15. As determined by study staff review of my medications a bisphosphonate for heterotopic ossification (HO), or other medications to treat osteoporosis other than calcium and vitamin D;
  16. Current diagnosis of cancer or history of cancer;
  17. As determined by study staff review of my medications, prescribed moderate or high dose corticosteroids (>40 mg/d prednisone or an equivalent dose of other corticosteroid medication) for longer than one week, not including drug administered to preserve neurological function at the time of acute SCI; and
  18. Life expectancy less than 5 years.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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): NCT05101018


Contacts
Layout table for location contacts
Contact: Christopher M Cirnigliaro, Ph.D 973-731-3900 ext 2755 christopher.cirnigliaro@va.gov
Contact: William A Bauman, M.D. 718-584-9000 ext 5428 william.bauman@va.gov

Locations
Layout table for location information
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    christopher.cirnigliaro@gmail.com   
Contact: Steven C Kirshblum, M.D.    973-731-3900 ext 2258    skirshblum@kessler-rehab.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: William A Bauman, M.D.    718-584-9000 ext 5427    william.bauman@va.gov   
Sponsors and Collaborators
James J. Peters Veterans Affairs Medical Center
Kessler Institute for Rehabilitation
Investigators
Layout table for investigator information
Principal Investigator: Steven C Kirshblum, M.D. Kessler Institute for Rehabilitation
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: William A. Bauman, M.D., Director VA RR&D National Center of Excellence for the Medical Consequences of Spinal Cord Injury, James J. Peters Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT05101018    
Other Study ID Numbers: BAU-19-22
First Posted: October 29, 2021    Key Record Dates
Last Update Posted: December 20, 2021
Last Verified: December 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by William A. Bauman, M.D., James J. Peters Veterans Affairs Medical Center:
Osteoporosis
Spinal Cord Injuries
Dual Energy X-ray Absorptiometry
Denosumab
Romosozumab
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoporosis
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
 Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs