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

NCT05101018 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: BAU-19-60
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteoporosis; Spinal Cord Injuries

Keywords

Osteoporosis; Spinal Cord Injuries; Dual Energy X-ray Absorptiometry; Denosumab; Romosozumab

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline to 24 months

Study Arms (2)

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

EXPERIMENTAL

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; Drug: Denosumab

Denosumab Baseline to Month 24

ACTIVE COMPARATOR

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

Interventions

Romosozumab DRUG

Romosozumab (Amgen Inc., Thousand Oaks, CA) 210mg SQ administered each month

Also known as: Evenity

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

Denosumab DRUG

Denosumab (Amgen Inc., Thousand Oaks, CA) 60 mg SQ administered every six months

Also known as: Prolia

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• James J. Peters Veterans Affairs Medical Center: lead
• Kessler Institute for Rehabilitation: collaborator

Study Sites (2)

Kessler Institute for Rehabilitation

West Orange, New Jersey, 07052, United States

Location

James J. Peters VA Medical Center

The Bronx, New York, 10468, United States

Location

Related Publications (3)

• 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.

  PMID: 30508316 BACKGROUND

• 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.

  PMID: 29573473 BACKGROUND

• 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.

  PMID: 29694685 BACKGROUND

MeSH Terms

Conditions

Osteoporosis; Spinal Cord Injuries

Interventions

romosozumab; Denosumab

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Steven C Kirshblum, M.D.

  Kessler Institute for Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: October 29, 2021
• Study Start: November 1, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

US (2)