Denosumab for Spinal Cord Injury

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Spinal Cord Injury+1 MoreDenosumab - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study Summary

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. Denosumab is a relative new, highly potent anti-resorptive agent that has proven efficacy in postmenopausal osteoporosis to improve bone mass and in solid tumor patients to prevent a skeletal-related event to a greater extent than that with bisphosphonate administration. In persons with complete motor lesions, bisphosphonates have not been effective at reducing bone loss at the knee, the site of greatest relevance because of its increased risk of fracture. Anti-RANKL therapy appears to be more potent than bisphosphonates in animal models of bone loss due to immobilization, suggesting that treatment with denosumab may prove to be an efficacious therapy for persons with acute SCI to preserve bone mass and strength.

Eligible Conditions
  • Spinal Cord Injury
  • Osteoporosis

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Baseline, 1, 3, 6, 12, and 18 months after Denosumab administration

Month 18
Bone mineral density (BMD) of the distal femur
Month 18
Bone microarchitecture of the distal femur and proximal tibia.

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Teriparatide
30%Contusion
15%Arthralgia
12%Nausea
12%Fatigue
12%Headache
9%Cough
9%Bronchitis
9%Pain in extremity
6%Hypokalaemia
6%Urine abnormality
6%Local swelling
6%Dysgeusia
6%Rash
3%Chest pain
3%Nasopharyngitis
3%Abdominal discomfort
3%Constipation
3%Joint swelling
3%Muscular weakness
3%Chronic obstructive pulmonary disease
3%Oropharyngeal pain
3%Vaginal discharge
3%Post procedural discomfort
3%Swelling face
3%Lung adenocarcinoma
3%Abdominal pain lower
3%Bone pain
3%Tendon disorder
3%Joint stiffness
3%Sensation of heaviness
3%Bladder spasm
3%Basal cell carcinoma
3%Nephrolithiasis
3%Sneezing
3%Onychoclasis
3%Lymph node pain
3%Dry eye
3%Spider vein
3%Diarrhoea
3%Gastroenteritis
3%Abdominal pain
3%Gastrooesophageal reflux disease
3%Injection site erythema
3%Ear infection
3%Thirst
3%Alopecia
3%Fall
3%Loss of consciousness
3%Groin pain
3%Foot deformity
3%Hyperhidrosis
3%Pruritus
3%Tremor
3%Urticaria
3%Haematoma
3%Dizziness
3%Skin induration
3%Hypotension
This histogram enumerates side effects from a completed 2014 Phase 4 trial (NCT01753856) in the Teriparatide ARM group. Side effects include: Contusion with 30%, Arthralgia with 15%, Nausea with 12%, Fatigue with 12%, Headache with 12%.

Trial Design

2 Treatment Groups

Denosumab
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

24 Total Participants · 2 Treatment Groups

Primary Treatment: Denosumab · Has Placebo Group · Phase 4

Denosumab
Drug
Experimental Group · 1 Intervention: Denosumab · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo (identical Denosumab volume of normal saline) · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Denosumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 1, 3, 6, 12, and 18 months after denosumab administration

Who is running the clinical trial?

Kessler Institute for RehabilitationIndustry Sponsor
22 Previous Clinical Trials
1,196 Total Patients Enrolled
James J. Peters Veterans Affairs Medical CenterLead Sponsor
53 Previous Clinical Trials
3,007 Total Patients Enrolled
William A Bauman, M.D.Principal InvestigatorJames J. Peters VA Medical Center
2 Previous Clinical Trials
53 Total Patients Enrolled
Steven C Kirshblum, M.D.Principal InvestigatorKessler Institute for Rehabilitation
2 Previous Clinical Trials
72 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 3 Total Inclusion Criteria

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