Romosozumab vs Denosumab for Osteoporosis After Spinal Cord Injury

Palo Alto (17 mi)

Dr. Steven Kirshblum, MD | West Orange ...

Overseen bySteven Kirshblum, MD

Age: 18 - 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: James J. Peters Veterans Affairs Medical Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing two ways to use medications that help keep bones strong in people with recent spinal cord injuries. One method uses a medication that helps build new bone for a period and then switches to another medication that prevents bone loss for another period. The other method uses only the medication that prevents bone loss for a longer period.

Eligibility Criteria

This trial is for men and premenopausal women aged 18-55 with a recent traumatic spinal cord injury (SCI) between C4-L2, who have not taken certain osteoporosis medications other than calcium and vitamin D. Participants must have a specific bone density level above the knee and cannot have conditions like chronic alcohol abuse, cancer history, severe chronic diseases, or be pregnant.

Inclusion Criteria

I have a spinal cord injury between C4 and L2, with some level of paralysis.

I am between 18 and 55 years old and if female, not past menopause.

Exclusion Criteria

I have a condition affecting my hormone glands, like an overactive thyroid or Cushing's.

I have been diagnosed with cancer or have a history of it.

I had a major leg bone fracture in the last year.

I have bone cancer.

I have or had heart disease or a stroke.

I have a history of bone disease like osteoporosis.

I am a woman who has gone through menopause.

I do not have severe chronic diseases like COPD, heart failure, or kidney failure.

I had low testosterone levels before my spinal cord injury.

I have been on more than 40 mg/day of corticosteroids for over a week, not for acute spinal cord injury.

I have high levels of calcium in my blood.

Treatment Details

The study tests if treating patients first with Romosozumab for 12 months followed by Denosumab for another year helps maintain bone mass at the knee better than just using Denosumab alone for two years in individuals with subacute SCI.

2Treatment groups

Experimental Treatment

Active Control

Group I: Romosozumab Baseline to Month 11 followed by Denosumab Month 12 to Month 24Experimental Treatment2 Interventions

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.

Group II: Denosumab Baseline to Month 24Active Control1 Intervention

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.

Denosumab is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Prolia for:

Osteoporosis in postmenopausal women
Bone loss associated with hormone ablation therapy for prostate cancer
Bone loss associated with hormone ablation therapy for breast cancer

🇺🇸 Approved in United States as Prolia for:

Treatment of postmenopausal women with osteoporosis at high risk for fracture
Treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer

🇨🇦 Approved in Canada as Prolia for:

Treatment of osteoporosis in postmenopausal women at high risk for fracture
Treatment to increase bone mass in men with osteoporosis at high risk for fracture

🇯🇵 Approved in Japan as Prolia for: