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

September 11, 2025 updated by: Chris Cardozo, James J. Peters Veterans Affairs Medical Center
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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. Romosozumab is a human monoclonal anti-sclerostin antibody bone anabolic agent that recently gained FDA approval to treat osteoporosis in postmenopausal women. This study will test the ability of romosozumab administered in FDA-approved therapeutic doses for 12 months to prevent loss of BMD to regions of interest of the lower extremities in persons with subacute SCI; attention will be focused to the knee region (distal femur), but the proximal tibia and hip regions will also be acquired and analyzed. The ability of denosumab to preserve the gains in BMD attained with romosozumab will be determined.The romosozumab + denosumab group will be compared to a group that receives 24 months of denosumab.

In persons with acute/subacute motor-compete SCI (<6 months since SCI), the primary objectives in the intervention group are to maintain baseline values of sublesional distal femur aBMD at 12 months after single drug therapy (12 months of romosozumab) and at 24 months after sequential dual drug therapy (12 months of romosozumab followed by 12 months of denosumab). This dual drug intervention group will be compared to a group that receives denosumab for 24 months; each active drug group will be compared to a historical control (placebo) group.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • West Orange, New Jersey, United States, 07052
        • Kessler Institute for Rehabilitation
    • New York
      • The Bronx, New York, United States, 10468
        • James J. Peters VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Traumatic motor-complete or incomplete SCI C4-L2 (AIS grade A-C);
  2. Duration of SCI less than 6 months;
  3. 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:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Evenity
Drug: Denosumab
Denosumab (Amgen Inc., Thousand Oaks, CA) 60 mg SQ administered every six months
Other Names:
  • 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 Names:
  • Prolia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

James J. Peters Veterans Affairs Medical Center

Collaborators

Kessler Institute for Rehabilitation

Investigators

  • Principal Investigator: Steven C Kirshblum, M.D., Kessler Institute for Rehabilitation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

October 14, 2021

First Submitted That Met QC Criteria

October 28, 2021

First Posted (Actual)

October 29, 2021

Study Record Updates

Last Update Posted (Estimated)

September 17, 2025

Last Update Submitted That Met QC Criteria

September 11, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAU-19-60

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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