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

Primary Purpose

Osteoporosis, Spinal Cord Injuries

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Romosozumab
Denosumab
Sponsored by
James J. Peters Veterans Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring Osteoporosis, Spinal Cord Injuries, Dual Energy X-ray Absorptiometry, Denosumab, Romosozumab

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kessler Institute for RehabilitationRecruiting
  • James J. Peters VA Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Romosozumab Baseline to Month 11 followed by Denosumab Month 12 to Month 24

Denosumab Baseline to Month 24

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Bone mineral density (BMD) of the distal femur metaphysis
BMD at the distal femur metaphysis will be obtained by dual energy X-ray absorptiometry (DXA)

Secondary Outcome Measures

Full Information

First Posted
October 14, 2021
Last Updated
October 10, 2023
Sponsor
James J. Peters Veterans Affairs Medical Center
Collaborators
Kessler Institute for Rehabilitation
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1. Study Identification

Unique Protocol Identification Number
NCT05101018
Brief Title
Treatment With Romosozumab Versus Denosumab to Improve Bone Mineral Density and Architecture in Subacute SCI
Official Title
Treatment With Romosozumab Versus Denosumab to Improve Bone Mineral Density and Architecture in Subacute SCI
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
November 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
James J. Peters Veterans Affairs Medical Center
Collaborators
Kessler Institute for Rehabilitation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Spinal Cord Injuries
Keywords
Osteoporosis, Spinal Cord Injuries, Dual Energy X-ray Absorptiometry, Denosumab, Romosozumab

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Romosozumab Baseline to Month 11 followed by Denosumab Month 12 to Month 24
Arm Type
Experimental
Arm Description
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.
Arm Title
Denosumab Baseline to Month 24
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Romosozumab
Other Intervention Name(s)
Evenity
Intervention Description
Romosozumab (Amgen Inc., Thousand Oaks, CA) 210mg SQ administered each month
Intervention Type
Drug
Intervention Name(s)
Denosumab
Other Intervention Name(s)
Prolia
Intervention Description
Denosumab (Amgen Inc., Thousand Oaks, CA) 60 mg SQ administered every six months
Primary Outcome Measure Information:
Title
Bone mineral density (BMD) of the distal femur metaphysis
Description
BMD at the distal femur metaphysis will be obtained by dual energy X-ray absorptiometry (DXA)
Time Frame
Baseline to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Traumatic motor-complete or incomplete SCI C4-L2 (AIS grade A-C); Duration of SCI less than 6 months; Males and females (premenopausal) between the ages of 18 and 55 years old; and a safe range of BMD right above the knee as determined by study staff review; Exclusion Criteria: Active and/or history of coronary heart disease or stroke; Bone cancer; Long-bone fracture of the leg within the past year; History of prior bone disease (for example, Paget's hyperparathyroidism, osteoporosis, etc.); Postmenopausal women; Men with known low functioning tests before SCI; Drugs geared toward increasing BMD longer than a six month duration after SCI; As determined by study staff review of my medication history of glucocorticoid administration longer than three months duration within the last year Abnormalities of my endocrine glands such as hyperthyroidism, Cushing's disease or syndrome, etc.; Severe underlying chronic disease (for example chronic obstructive pulmonary disease (COPD), end-stage heart disease, chronic renal failure); 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.; History of chronic alcohol abuse; Diagnosis of hypercalcemia (high levels of calcium in the blood); Pregnancy; 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; Current diagnosis of cancer or history of cancer; 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 Life expectancy less than 5 years.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher M Cirnigliaro, Ph.D
Phone
973-731-3900
Ext
2755
Email
christopher.cirnigliaro@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher P Cardozo, M.D.
Phone
718-584-9000
Ext
1828
Email
christopher.cardozo@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven C Kirshblum, M.D.
Organizational Affiliation
Kessler Institute for Rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kessler Institute for Rehabilitation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher M Cirnigliaro, M.S.
Phone
973-731-3900
Ext
2755
Email
christopher.cirnigliaro@gmail.com
First Name & Middle Initial & Last Name & Degree
Steven C Kirshblum, M.D.
Phone
973-731-3900
Ext
2258
Email
skirshblum@kessler-rehab.com
First Name & Middle Initial & Last Name & Degree
Christopher M Cirnigliaro, M.S.
First Name & Middle Initial & Last Name & Degree
Steven C Kirshblum, M.D.
Facility Name
James J. Peters VA Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher P Cardozo, M.D.
Phone
718-584-9000
Ext
1828
Email
christopher.cardozo@va.gov

12. IPD Sharing Statement

Citations:
PubMed Identifier
30508316
Citation
Lewiecki EM, Dinavahi RV, Lazaretti-Castro M, Ebeling PR, Adachi JD, Miyauchi A, Gielen E, Milmont CE, Libanati C, Grauer A. One Year of Romosozumab Followed by Two Years of Denosumab Maintains Fracture Risk Reductions: Results of the FRAME Extension Study. J Bone Miner Res. 2019 Mar;34(3):419-428. doi: 10.1002/jbmr.3622. Epub 2018 Dec 3.
Results Reference
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PubMed Identifier
29573473
Citation
Cosman F, Crittenden DB, Ferrari S, Khan A, Lane NE, Lippuner K, Matsumoto T, Milmont CE, Libanati C, Grauer A. FRAME Study: The Foundation Effect of Building Bone With 1 Year of Romosozumab Leads to Continued Lower Fracture Risk After Transition to Denosumab. J Bone Miner Res. 2018 Jul;33(7):1219-1226. doi: 10.1002/jbmr.3427. Epub 2018 May 17.
Results Reference
background
PubMed Identifier
29694685
Citation
McClung MR, Brown JP, Diez-Perez A, Resch H, Caminis J, Meisner P, Bolognese MA, Goemaere S, Bone HG, Zanchetta JR, Maddox J, Bray S, Grauer A. Effects of 24 Months of Treatment With Romosozumab Followed by 12 Months of Denosumab or Placebo in Postmenopausal Women With Low Bone Mineral Density: A Randomized, Double-Blind, Phase 2, Parallel Group Study. J Bone Miner Res. 2018 Aug;33(8):1397-1406. doi: 10.1002/jbmr.3452. Epub 2018 May 22.
Results Reference
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Treatment With Romosozumab Versus Denosumab to Improve Bone Mineral Density and Architecture in Subacute SCI

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