Denosumab for Spinal Cord Injury

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen BySteven C Kirshblum, M.D.

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: James J. Peters Veterans Affairs Medical Center

Prior Safety Data

Approved in 4 jurisdictions

Trial Summary

What is the purpose of this trial?This trial is testing if the drug denosumab can prevent bone loss in people who have had a recent spinal cord injury. The drug is already used for other bone loss conditions but is experimental for this purpose. It works by stopping the process that breaks down bones, helping to keep them strong.

Eligibility Criteria

Participant Groups

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Denosumab, AIS Grade D (ambulatory)Experimental Treatment1 Intervention

8 subjects with AIS grade D will be randomized to receive Denosumab (Prolia 120mg SC) administered at baseline and 6 months.

Group II: Denosumab, AIS Grade C (non-ambulatory)Experimental Treatment1 Intervention

8 subjects with AIS grade C will be randomized to receive Denosumab (Prolia 120mg SC) administered at baseline and 6 months.

Group III: Placebo, AIS Grade D (ambulatory)Placebo Group1 Intervention

8 subjects with AIS grade D will be randomized to the placebo group and will receive the identical volume of normal saline at parallel time points.

Group IV: Placebo, AIS Grade C (non-ambulatory)Placebo Group1 Intervention

8 subjects with AIS grade C will be randomized to the placebo group and will receive the identical volume of normal saline at parallel time points.

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: