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Monoclonal Antibodies

Burosumab for Osteoporosis Hypophosphatemia Syndrome

Q: Is it still feasible to enroll in this investigation?

At this moment, no new participants are being sought for the trial. It was initially posted on July 1st 2019 and its last update occurred on March 4th 2022. For those who are searching for alternative studies, there are presently 1404 trials enrolling patients with hypophosphatemia and four clinical trials looking to recruit people prescribed Burosumab.

Q: What is the maximum number of participants accepted for this clinical experiment?

At this moment, the trial is not actively enrolling participants. It was initially advertised on July 1st 2019 and last updated on March 4th 2022. If you are in search of other trials related to hypophosphatemia, 1404 studies are currently seeking patients; for Burosumab there are four active medical studies recruiting volunteers.

Q: Has this sort of research been conducted before?

Burosumab is currently the subject of 4 live trials, spanning 8 different countries and 1 city. First tested in 2019, this drug has since been through 18 studies conducted by Ultragenyx Pharmaceutical Inc., with its initial Phase &#x3C; 1 clinical trial involving a single patient as part of their drug approval process.

Phase < 1

Waitlist Available

Led By Laura Tosi, MD

Research Sponsored by Laura Tosi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

Study Summary

This trial is testing whether the drug burosumab can help patients with Cutaneous Skeletal Hypophosphatemia Syndrome by reducing the levels of a protein called fibroblast growth factor 23.

Eligible Conditions

Osteoporosis Hypophosphatemia Syndrome (OHS)
Epidermal Nevus Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Serum Phosphorus change

Secondary outcome measures

6-minute walk test

Biomechanical Marker

Brief Fatigue Inventory (BFI)

+10 more

Side effects data

From 2021 Phase 2 trial • 17 Patients • NCT02304367

64%

Pain In Extremity

64%

Arthralgia

50%

Upper Respiratory Tract Infection

50%

Cough

43%

Diarrhoea

36%

Nausea

36%

Vomiting

36%

Nasopharyngitis

36%

Back Pain

36%

Muscle Spasms

29%

Hypertension

29%

Insomnia

29%

Constipation

29%

Neoplasm Progression

29%

Urinary Tract Infection

29%

Musculoskeletal Pain

29%

Pain

29%

Fall

29%

Myalgia

29%

Amylase Increased

21%

Abdominal Pain

21%

Influenza

21%

Procedural Pain

21%

Contusion

21%

Ligament Sprain

21%

Pulmonary Mass

21%

Hypomagnesaemia

21%

Oropharyngeal Pain

21%

Nasal Congestion

21%

Rash

21%

Musculoskeletal Chest Pain

21%

Restless Legs Syndrome

21%

Oedema Peripheral

21%

Vitamin D Deficiency

21%

Joint Range Of Motion Decreased

21%

Fatigue

21%

Respiratory Tract Congestion

21%

Bronchitis

14%

Injection Site Reaction

14%

Abdominal Pain Lower

14%

Lipase Increased

14%

Cardiac Arrest

14%

Creatinine Renal Clearance Decreased

14%

Hyperphosphataemia

14%

Foot Fracture

14%

Upper Respiratory Tract Congestion

14%

Asthenia

14%

Acute Respiratory Failure

14%

Hypokalaemia

14%

Hypotension

14%

Hyperglycaemia

14%

Hypocalcaemia

14%

Dyspnoea

14%

Anxiety

14%

Pyrexia

14%

Anaemia

14%

Tinnitus

14%

Toothache

14%

Decreased Appetite

14%

Bone Lesion

14%

Bone Pain

14%

Nephrolithiasis

14%

Tooth Fracture

14%

Depression

14%

Chills

14%

Exostosis

14%

Neck Pain

14%

Dizziness

14%

Headache

14%

Acute Kidney Injury

14%

Abdominal Discomfort

14%

Abdominal Distension

14%

Rib Fracture

14%

Joint Swelling

Blood Creatine Increased

Thyroid Neoplasm

Testicular Mass

Skin Lesion

Computerised Tomogram Abdomen Abnormal

Hyponatraemia

Intervertebral Disc Annular Tear

Cholangitis

Coagulopathy

Metabolic Acidosis

Multi-Organ Failure

Pickwickian Syndrome

Blood Glucose Increased

Nodule

Cystitis

Metastases To Lung

Hepatic Lesion

Flank Pain

Hydronephrosis

Skin Irritation

Liver Function Test Abnormal

Rash Papular

Melanocytic Naevus

Application Site Rash

Injection Site Bruising

Gout

Electrocardiogram Qt Prolonged

Electrocardiogram Abnormal

Hypoproteinaemia

Hip Fracture

Tooth Injury

Clonus

Viith Nerve Paralysis

H1n1 Influenza

Oxygen Saturation Decreased

Hypercalcaemia

Injection Site Swelling

Medical Device Site Reaction

Tumour Compression

Diverticulitis

Rheumatoid Arthritis

Pulseless Electrical Activity

Sialoadenitis

Blood Creatinine Increased

Waist Circumference Increased

Hypoalbuminaemia

Sensory Disturbance

Panic Attack

Micturition Urgency

Precancerous Skin Lesion

Deep Vein Thrombosis

Abdominal Pain Upper

Squamous Cell Carcinoma Of Skin

Metastases To Pancreas

Prostatomegaly

Blood Cholesterol Increased

Haemothorax

Glycosylated Haemoglobin Increased

Haematuria

Pulmonary Artery Dilatation

Hyperuricaemia

Decubitus Ulcer

Hypophosphataemia

Joint Stiffness

Agitation

Keloid Scar

Peripheral Venous Disease

Nephrocalcinosis

Vasodilatation

Skin Mass

Basal Cell Carcinoma

Actinic Keratosis

Cerebral Cyst

Sleep Talking

Skin Odour Abnormal

Urinary Incontinence

Pulmonary Embolism

Renal Impairment

Concussion

Muscle Mass

Vaginal Haemorrhage

Echocardiogram Abnormal

Eyelid Ptosis

Ascites

Bile Duct Stone

Hepatic Cyst

Poor Quality Sleep

Ovarian Cancer

Leukocytosis

Bradycardia

Tachycardia

Abdominal Mass

Dysphagia

Flatulence

Gastrooesophageal Reflux Disease

Hypoaesthesia Oral

Large Intestine Polyp

Localised Intraabdominal Fluid Collection

Poor Dental Condition

Retching

Stomatitis

Calcinosis

Chest Pain

Generalised Oedema

Seasonal Allergy

Oesophageal Candidiasis

Oral Candidiasis

Pneumonia

Sinusitis

Tooth Abscess

Viral Upper Respiratory Tract Infection

Ligament Rupture

Blood Calcium Increased

Blood Parathyroid Hormone Increased

Blood Potassium Decreased

Blood Pressure Systolic Increased

Blood Sodium Decreased

Blood Uric Acid Increased

White Blood Cell Count Decreased

Aneurysmal Bone Cyst

Bursitis

Osteosclerosis

Neuroma

Pollakiuria

Proteinuria

Renal Cyst

Dental Caries

Road Traffic Accident

Calculus Bladder

Pancreatic Carcinoma Metastatic

Pleural Effusion

Pancreatitis

Dyspepsia

Gait Disturbance

Peripheral Swelling

Gastrointestinal Infection

Gastrointestinal Viral Infection

Laceration

Post Procedural Haematoma

Scar

Skin Abrasion

Spinal Compression Fracture

Stress Fracture

Tibia Fracture

Ultrasound Kidney Abnormal

Hypercholesterolaemia

Soft Tissue Mass

Tendon Pain

Schwannoma

Squamous Cell Carcinoma

Dysgeusia

Hypoaesthesia

Sciatica

Vulva Cyst

Respiratory Acidosis

Pruritus

Septic Shock

Abdominal Hernia

Injection Site Pain

Conjunctivitis

Corona Virus Infection

Femur Fracture

Fibula Fracture

Radiation Mucositis

Musculoskeletal Stiffness

Migraine

Neuralgia

Paraesthesia

Chylothorax

Prostatic Specific Antigen Increased

100%

80%

60%

40%

20%

Study treatment Arm

KRN23 TIO

KRN23 XLH and ENS

Trial Design

1Treatment groups

Experimental Treatment

Group I: BurosumabExperimental Treatment1 Intervention

Burosumab, which is FDA-approved for X-linked hypophosphatemic rickets, will be given monthly, for a total of 12 months and titrated to achieve a target fasting serum phosphorus level within normal range for age. The chosen starting dose of burosumab will be 0.3 mg/kg given SQ Q4W. The maximum dose allowed in this protocol is 2.0 mg/kg. Burosumab will be administered via subcutaneous (SC) route.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Burosumab

2021

Completed Phase 3

~110

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ultragenyx Pharmaceutical IncIndustry Sponsor

89 Previous Clinical Trials

179,073 Total Patients Enrolled

Laura TosiLead Sponsor

Children's National Research InstituteOTHER

210 Previous Clinical Trials

207,756 Total Patients Enrolled

Frequently Asked Questions

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

Is it still feasible to enroll in this investigation?

"At this moment, no new participants are being sought for the trial. It was initially posted on July 1st 2019 and its last update occurred on March 4th 2022. For those who are searching for alternative studies, there are presently 1404 trials enrolling patients with hypophosphatemia and four clinical trials looking to recruit people prescribed Burosumab."

Answered by AI

What is the maximum number of participants accepted for this clinical experiment?

"At this moment, the trial is not actively enrolling participants. It was initially advertised on July 1st 2019 and last updated on March 4th 2022. If you are in search of other trials related to hypophosphatemia, 1404 studies are currently seeking patients; for Burosumab there are four active medical studies recruiting volunteers."

Answered by AI

Has this sort of research been conducted before?

"Burosumab is currently the subject of 4 live trials, spanning 8 different countries and 1 city. First tested in 2019, this drug has since been through 18 studies conducted by Ultragenyx Pharmaceutical Inc., with its initial Phase < 1 clinical trial involving a single patient as part of their drug approval process."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Burosumab for CSHS

Laura Tosi 2019. "Burosumab for CSHS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03993821.