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Treatment With Romosozumab to Improve Bone Mineral Density and Architecture in Chronic SCI

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ClinicalTrials.gov Identifier: NCT05180032
Recruitment Status : Recruiting
First Posted : January 6, 2022
Last Update Posted : April 11, 2022
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
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Brief Summary:
The objective of the proposed work is to determine whether administration for 12 months of romosozumab (evenity) followed by 12 months of denosumab (prolia) will maintain bone mass at the knee in subjects with chronic SCI.

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

Detailed Description:
The purpose of this study is to address the gap in the treatment of osteoporosis in individuals with chronic SCI by partially restoring BMD with romosozumab treatment for 12 months and then to maintain, or further increase, BMD with denosumab treatment for 12 months. A two group, randomized, double-blind, placebo-controlled clinical trial will be conducted in 39 participants who have chronic (3-15 years), motor-complete or incomplete SCI and areal BMD (aBMD) values at the distal femur of at the distal femur ≥0.6 g/cm2 but ≤1.0 g/cm2 measured by dual photon X-ray absorptiometry (DXA). The intervention group will receive 12 months of romosozumab followed by 12 months of denosumab, and the control group will receive 12 months of placebo followed by 12 months denosumab
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Treatment With Romosozumab to Improve Bone Mineral Density and Architecture in Chronic SCI
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : March 1, 2025
Estimated Study Completion Date : March 1, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Romosozumab group
Romosozumab (evenity) administered monthly from baseline to month 11 followed by denosumab (prolia) at month 12 and 18
 Drug: Romoszumab
Monthly SQ injections
Other Name: Evenity

Drug: Denosumab
2 injections 6 months apart SQ
Other Name: Prolia
Placebo Comparator: Control group
Placebo administered monthly from baseline to month 11 followed by denosumab (prolia) at month 12 and 18
 Drug: Denosumab
2 injections 6 months apart SQ
Other Name: Prolia

Drug: Placebo
Monthly Placebo Injections


Outcome Measures
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Primary Outcome Measures :
  1. Bone mineral density (BMD) [ Time Frame: Baseline to 24 months ]
    BMD of the distal femur metaphysis


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1) Motor complete or incomplete SCI C4 and below {upper motor lesions; International Standards for Neurological Classification of Spinal Cord Injury (ISNSCI) grade A-C (wheelchair dependent greater than 75% of the time)
  • 2) Duration of SCI between 3-15 years;
  • 3) Males and females (premenopausal) between the ages of 18 and 50 years old (the upper age limit is to reduce the influence of age on the ability of the skeleton to respond to pharmacologic stimulation);
  • 4) aBMD at the distal femur greater than or equal to 0.6 g/cm2 but less than or equal to 1.0 g/cm2;
  • 5) Agreement to use a highly effective contraceptive method for women of reproductive potential.

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 (overproduction of a steroid hormone known as the parathyroid hormone), osteoporosis, etc.];
  • 5) Postmenopausal women;
  • 6) Men with known low functioning testes before SCI;
  • 7) Medication designed to increase bone density longer than six months after duration of SCI;
  • 8) As determined by study staff review of my medication, glucocorticoid (anti-inflammatory medications) administration longer than three months duration within the last year;
  • 9) Endocrinopathies such as the following: hyperthyroidism (overproduction of a hormone known as thyroxine by the thyroid gland in the neck), Cushing's disease or syndrome (excess production of the steroid hormone cortisol), etc.;
  • 10) Severe underlying chronic disease [for example chronic obstructive pulmonary (lung) disease (COPD, end-stage heart disease, chronic renal (kidney) failure];
  • 11) Heterotopic ossification (HO- an abnormal growth of bone that can occur after SCI) at the distal femur (the distal femur is the primary outcome variable; HO to any other boney region will not prevent study participation);
  • 12) As determined by study staff review of my medication, prescribed a bisphosphonate for heterotopic ossification (HO), or prescribed any other agent to treat osteoporosis other than calcium and vitamin D;
  • 13) History of chronic alcohol abuse;
  • 14) Diagnosis of hypercalcemia (excess calcium levels in the blood);
  • 15) Diagnosis of hypocalcemia (low calcium levels in the blood). If corrected, subject may still be eligible for study participation);
  • 16) Pregnancy, or plans to become pregnant within 6 months after the end of study treatment;
  • 17) Lactation;
  • 18) Current diagnosis of cancer or history of cancer within the last 5 years;
  • 19) As determined by study staff review of my medication, 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;
  • 20) As determined by study staff review of my medical records, life expectancy less than 5 years;
  • 21) History of hypersensitivity reaction (including allergic reaction, facial swelling and hives) to any Prolia (denosumab) or Evenity (romosozumab) component;
  • 22) Currently experiencing a weakened immune system or infection;
  • 23) Recent fracture or extensive bone trauma;
  • 24) Osteonecrosis of the jaw (ONJ- deterioration of the jaw bone) or risk for ONJ, such as invasive dental procedures (including tooth extraction, dental implants, oral surgery in the past 6 months), poor oral hygiene, periodontal and/or pre-existing dental disease;
  • 25) Planned invasive dental procedure over the next two years.
Contacts and Locations
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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): NCT05180032


Contacts
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Contact: Christopher Cirnigliaro, PhD 973-731-3900 ext 2755 christopher.cirnigliaro@va.gov

Locations
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United States, New Jersey
Kessler Institute for Rehabilitation Recruiting
West Orange, New Jersey, United States, 07052
Contact: Christopher M Cirnigliaro, PhD    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, PhD         
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
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Principal Investigator: William A Bauman, MD James J Peters VA Medical Center
More Information
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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: NCT05180032    
Other Study ID Numbers: BAU-19-66
First Posted: January 6, 2022    Key Record Dates
Last Update Posted: April 11, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Denosumab
Romosozumab
Dual Energy X-ray Absorptiometry
Additional relevant MeSH terms:
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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