CLINICAL TRIAL

Denosumab (Prolia) for Wounds

Recruiting · 18+ · All Sexes · West Orange, NJ

This study is evaluating whether a drug which is FDA approved to treat osteoporosis may help prevent bone loss in individuals with spinal cord injury.

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About the trial for Wounds

Eligible Conditions
Secondary Osteoporosis · Spinal Cord Injuries · Osteoporosis · Wounds and Injuries · Spinal Cord Injuries (SCI)

Treatment Groups

This trial involves 4 different treatments. Denosumab (Prolia) is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Experimental Group 1
Denosumab (Prolia)
DRUG
Experimental Group 2
Denosumab (Prolia)
DRUG
Control Group 3
Placebo (normal saline)
OTHER
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Denosumab
FDA approved

Side Effect Profile for Control

Control
Show all side effects
16%
Tremor
16%
Enteritis
14%
Lymphocele
11%
CMV viremia
11%
Transplant pyelonephritis
11%
Urinary tract infections
11%
Sore throat
9%
Diarrhea
9%
Hemorrhoids
9%
Thrombosis
9%
Exanthema
7%
Headache
7%
Muscle pain
7%
Aphtous stomatitis
7%
Rhinorrhea
7%
Fever
7%
Neck/back pain
7%
Oral candidiasis
5%
Surgical intervention
5%
Urinary tract infection
5%
Hydronephrosis
5%
Vomiting
2%
Respiratory infection
2%
Skin cancer
2%
Transplant artery stenosis
2%
Uterus myomatosus
2%
Edema
2%
Alopecia
2%
Flu-like disease
2%
Dyspnea
2%
Functional decline of transplant function
2%
Diabetes (post-transplant)
2%
Peripheral arterial vascular disease
2%
Sinusitis
2%
Wound dehiscence
2%
Retinitis
2%
Bilateral nephrectomy of polycystic kidneys
2%
Hypocalcemia
2%
Nephrolithiasis
2%
Transplant ureter stenosis
0%
Tonsillitis
0%
Dysuria
0%
Folliculitis
0%
Abscess
0%
Transplant reflux testing
0%
Generalized weakness
0%
Abdominal pain
0%
Hernia
0%
Hematoma
0%
Acute rejection
0%
Pulmonary embolism
0%
Chest pain
0%
Aneurysm
0%
Ileus
0%
Hyponatremia
0%
Infection without focus
0%
Hematuria
0%
Urethral stricture
0%
Selective ureteral sampling
0%
Herpes zoster
0%
Fecal blood
0%
Choledocholithiasis
0%
Ureteral leakage
Tremor
16%
Enteritis
16%
Lymphocele
14%
CMV viremia
11%
Transplant pyelonephritis
11%
Urinary tract infections
11%
Sore throat
11%
Diarrhea
9%
Hemorrhoids
9%
Thrombosis
9%
Exanthema
9%
Headache
7%
Muscle pain
7%
Aphtous stomatitis
7%
Rhinorrhea
7%
Fever
7%
Neck/back pain
7%
Oral candidiasis
7%
Surgical intervention
5%
Urinary tract infection
5%
Hydronephrosis
5%
Vomiting
5%
Respiratory infection
2%
Skin cancer
2%
Transplant artery stenosis
2%
Uterus myomatosus
2%
Edema
2%
Alopecia
2%
Flu-like disease
2%
Dyspnea
2%
Functional decline of transplant function
2%
Diabetes (post-transplant)
2%
Peripheral arterial vascular disease
2%
Sinusitis
2%
Wound dehiscence
2%
Retinitis
2%
Bilateral nephrectomy of polycystic kidneys
2%
Hypocalcemia
2%
Nephrolithiasis
2%
Transplant ureter stenosis
2%
Tonsillitis
0%
Dysuria
0%
Folliculitis
0%
Abscess
0%
Transplant reflux testing
0%
Generalized weakness
0%
Abdominal pain
0%
Hernia
0%
Hematoma
0%
Acute rejection
0%
Pulmonary embolism
0%
Chest pain
0%
Aneurysm
0%
Ileus
0%
Hyponatremia
0%
Infection without focus
0%
Hematuria
0%
Urethral stricture
0%
Selective ureteral sampling
0%
Herpes zoster
0%
Fecal blood
0%
Choledocholithiasis
0%
Ureteral leakage
0%
This histogram enumerates side effects from a completed 2015 Phase 3 trial (NCT01377467) in the Control ARM group. Side effects include: Tremor with 16%, Enteritis with 16%, Lymphocele with 14%, CMV viremia with 11%, Transplant pyelonephritis with 11%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
some hand function Some people with a motor incomplete SCI have some hand function. show original
Duration of injury < 6-months;
People between the ages of 18 and 50 years old. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Prior to denosumab or placebo administration and 12 months after denosumab or placebo administration
Screening: ~3 weeks
Treatment: Varies
Reporting: Prior to denosumab or placebo administration and 12 months after denosumab or placebo administration
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Prior to denosumab or placebo administration and 12 months after denosumab or placebo administration.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Denosumab (Prolia) will improve 1 primary outcome and 1 secondary outcome in patients with Wounds. Measurement will happen over the course of Prior to denosumab or placebo administration and 18 months after denosumab or placebo administration.

areal bone mineral density (aBMD) by dual energy X-ray absorptiometry (DXA)
PRIOR TO DENOSUMAB OR PLACEBO ADMINISTRATION AND 18 MONTHS AFTER DENOSUMAB OR PLACEBO ADMINISTRATION
Efficacy of denosumab to prevent aBMD loss at the distal femur and proximal tibia
PRIOR TO DENOSUMAB OR PLACEBO ADMINISTRATION AND 18 MONTHS AFTER DENOSUMAB OR PLACEBO ADMINISTRATION
volumetric BMD (vBMD) and microarchitecture by peripheral quantitative computed tomography
PRIOR TO DENOSUMAB OR PLACEBO ADMINISTRATION AND 12 MONTHS AFTER DENOSUMAB OR PLACEBO ADMINISTRATION
Efficacy of denosumab to prevent vBMD loss and microarchitecture deterioration at the distal femur and proximal tibia
PRIOR TO DENOSUMAB OR PLACEBO ADMINISTRATION AND 12 MONTHS AFTER DENOSUMAB OR PLACEBO ADMINISTRATION

Who is running the study

Principal Investigator
W. A. B. M.
William A. Bauman M.D., Director, Clinical Investigator, National Center of Excellence for the Medical Consequences of Spinal Cord Injury
James J. Peters Veterans Affairs Medical Center

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does denosumab (prolia) improve quality of life for those with wounds?

The administration of denosumab (Prolix) improved QoL in patients with painful bone metastatic disease, particularly the improvement of EODS. Denosumab (Prolix) may also reduce the overall pain intensity.

Anonymous Patient Answer

Can wounds be cured?

Most chronic wounds can be cured with a variety of effective treatments in the right circumstances. In some cases, a cure occurs by its self, when a wound is managed in a good manner, without the use of surgery.

Anonymous Patient Answer

What is wounds?

Wounds heal, at least partially, through scarring and the formation of collagen. The collagen scar is highly vascularized, in part through vasopressins. Increased blood flow is necessary to overcome the formation of scar tissue. The scar is composed of the extracellular matrix and collagen. The extracellular matrix is the precursor of the extracellular matrix. Collagen is the main element of the extracellular matrix. Collagen has many functions. Collagen serves as a scaffold to help cells attach, and a cell-signaling molecule. Most cells, after they bind to collagen, express specific proteins to assist in cell adhesion. The collagen fibers are organized in bundles.

Anonymous Patient Answer

How many people get wounds a year in the United States?

About one million people get a wound a year in the United States. Overall, about one billion wounds are treated each year in the United States. While most wounds from accidents and falls will be manageable, more serious injuries are more difficult to treat. However, in the United States, treatment in the emergency department remains low and a significant proportion of patients are discharged without having been examined by a physician.

Anonymous Patient Answer

What are common treatments for wounds?

Many wound treatments exist that differ widely in their efficacy and are reliant on the particular wound type. Treatments are often chosen based on treatment success/failure and individual patient need. Although the efficacy of all treatments available for burn and scald injuries has not been adequately evaluated, evidence suggests that they should be preferred over wait-and-see management, because of the higher risk of infections in the latter approach.

Anonymous Patient Answer

What are the signs of wounds?

Some of the most common signs of wounds include redness, tenderness or discharge. These signs are due to infection in 20-60% of the cases depending on the age group. The commonest sign (30-45% in all age groups) is bleeding. A history of chronic pain, and inability to fully extend the elbow, fingers, knee and toes may be related to arthritis. Patients under 16 years who complain of persistent soreness can have an underlying gastrointestinal problem. Other signs and symptoms depend on the underlying diagnosis of the wound.

Anonymous Patient Answer

What causes wounds?

Although wounds are mostly the result of disease, they can also be caused by wounds that are too small or too small relative to the size of the patient. Wounds that result in healing without scarring and wounds that are too large cause problems. Wounds can be caused by a variety of factors, some of which include trauma and infection. Wounds that have not adequately healed can be the result of an allergic reaction or an adverse reaction to drugs or surgical equipment. Wound healing always requires careful observation, however, in many cases the healing takes a relatively long time.

Anonymous Patient Answer

Has denosumab (prolia) proven to be more effective than a placebo?

These data suggest that a bisphosphonate may provide some benefit. The benefit, if any, could be related more to improved fracture-healing than to disease stabilization or fracture prevention. Further research is warranted to investigate longer-lasting effects.

Anonymous Patient Answer

Is denosumab (prolia) typically used in combination with any other treatments?

Both denosumab 75 mg and 100 mg are effective in the short-term treatment of osteoporotic vertebral compression fractures. However, the benefit of denosumab is significantly less than that of the standard-of-care treatment with bisphosphonates.

Anonymous Patient Answer

What does denosumab (prolia) usually treat?

Denosumab, like many other therapeutic agents (e.g., antibiotics, NSAID, or diuretics), can affect normal physiological processes that depend on the normal functioning of bones and teeth (anatomic dynamics, bone and tooth mineralization, turnover, and bone remodeling). The risk should be considered with denosumab in patients with renal impairment or on dialysis. Because denosumab may affect these normal physiological processes in bone, it may trigger an unexpected adverse reaction such as a fracture. Patients with diabetes mellitus and renal dysfunction who take denosumab should be closely monitored.

Anonymous Patient Answer

Have there been other clinical trials involving denosumab (prolia)?

At least two other clinical trials involving denosumab in patients with osteosarcoma are being performed. There remains potential interest in investigating the use of denosumab in patients with NSCLC.

Anonymous Patient Answer

What is the average age someone gets wounds?

Average age was 60.8 years. In a 5-year period (2010-2015), 15% of male patients and 39% female patients received wounds. In this small sample size, there was no statistically significant difference between male and female patients. It is suggested that wound healing time could influence the age of onset.

Anonymous Patient Answer
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