Introduction:
Chronic kidney disease is one of the kidney impairments resulting in osteoporosis complications. Osteoporosis is characterized by a systemic impairment of bone mass and microarchitecture, resulting in fractures. Sclerostin is a protein involved in the regulation of bone formation. People with chronic kidney disease (CKD) have a three to five-fold increased osteoporosis risk compared with the general population. Therefore, Romosozumab is a therapeutic option that induces bone formation and inhibits bone resorption. This procedure occurs because of the inhibition action of sclerotin.
What Is Romosozumab?
It is a humanized monoclonal antibody used in the treatment of osteoporosis. Romosozumab is used in those who are at high risk of fracture, patients who are not responding to other treatments, or who cannot tolerate other osteoporosis therapies.
When and Who Approved Romosozumab?
Romosozumab was approved on April 9, 2019, by the Food and Drug Administration (FDA).
What Is the Action of Romosozumab?
Romosozumab is injected subcutaneously to inhibit a protein called sclerostin. By inhibiting sclerostin, it allows canonical Wnt signaling in osteoblasts - induces bone formation, and inhibits receptor activator of nuclear factor kappa-beta-ligand (RANKL). RANKL causes bone resorption by osteoclasts. Both effects are seen only in Romosozumab than in other treatments of osteoporosis.
How Much Is the Bioavailability of Romosozumab?
Romosozumab reaches peak concentration in an average of 5 days. Subcutaneous bioavailability is 50 % to 70 %.
What Is the Metabolism of Romosozumab?
Romosozumab is degraded into small peptides and amino acids.
What Are the Adverse Effects of Romosozumab?
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Hypocalcemia: Patients with severe kidney impairment or those on dialysis are at an increased risk of hypocalcemia.
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Obesity: The patient’s weight affects the level of exposure to Romosozumab.
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Cardiac Events: Increased heart attack, stroke, and cardiovascular death risk.
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Hypersensitivity: Angioedema, erythema multiforme, dermatitis, rash, urticaria.
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Osteonecrosis Of The Jaw: Monitor for symptoms and discontinue the therapy.
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Atypical Femoral Fracture: Show new or unusual pain in the thigh, hip, or groin.
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Others:Joint pain, headache, and pain at the injection site.
When Is Romosozumab Not Indicated?
Romosozumab is not indicated in the following conditions:
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Pregnancy.
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Lactation.
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Pediatric patients.
A study on rats showed an association with skeletal defects in their offspring when romosozumab was given and detected in milk excreted.
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Cardiac events like a heart attack or stroke.
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Hypocalcemia.
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Known hypersensitivity.
Which Are the Conditions That Are Not Affected by Romosozumab?
Carcinogenicity: A study on rats showed no effect on mortality and tumor incidence.
Mutagenicity: Do not alter DNA (Deoxyribose Nucleic Acid) or chromosomes.
Fertility: No effect was observed on fertility.
What Dosage is to Be Given?
Injection of 105 mg/1.17 mL solution in a prefilled syringe. Two injections of 210 mg is the total dose required. The drug is administered subcutaneously once every month, a total of 12 doses in the abdomen, thigh, or upper form, and adequately supplemented by calcium and vitamin D during treatment.
How to Store and Handle Romosozumab?
Refrigerate at two to eight degrees Celsius in a carton to protect from light. Do not freeze or shake.
What Is Kidney Impairment?
Kidney failure is a condition when one or both kidneys do not work. It may develop early. It May remain for a long time or temporarily and may get worse slowly.
Who Gets Kidney Impairment?
Anyone can be affected, especially those having:
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Diabetes.
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High blood pressure.
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Heart disease.
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Family history of kidney disease.
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With abnormal kidney structure.
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Blacks, Hispanic, Native Americans, Alaska Natives, or First Nation.
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Over 60 years.
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A long history of taking pain relievers.
How Common Is Kidney Impairment?
It affects two million individuals worldwide.
What Happens When Kidney Failure Starts?
Kidney impairment is calculated by estimated glomerular filtration rate (eGFR). The eGFR shows how well kidneys filter substances. Normal eGFR is about 100. The lowest eGFR is 0, which means no kidney function.
Stages of kidney disease:
Stage I: GFR is more than 90 but below 100. It means mild damage and still functions normally.
Stage II: GFR is 60 or as high as 89. It means more damage than stage I; however, it still functions well.
Stage III: GFR is 30 or as high as 59. It means mild or severe loss of kidney function.
Stage IV: GFR is 15 or as high as 29. It indicates severe loss of kidney function.
Stage V: GFR is below 15. It denotes that the kidneys have completely failed.
What Are the Symptoms of Kidney Impairment?
Vary from one person to another.
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Fatigue.
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Nausea and vomiting.
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Confusion.
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Swelling of hands, ankles, or face.
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Frequent urination.
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Muscle spasms.
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Dry, itchy skin.
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Poor appetite or food may taste metallic.
What Are the Causes of Kidney Impairment?
Diabetes: Uncontrolled diabetes leads to high blood sugar levels (hyperglycemia).
Consistent high blood sugar damages the kidneys.
Hypertension: Blood travels forcefully through blood vessels. If left untreated and with time, it damages the kidney.
Polycystic Kidney Disease: An inherited condition that causes fluid-filled sacs to grow in the kidney.
Glomerular Disease: Affect filtration of kidneys.
Lupus: An autoimmune disease that causes organ damage, joint pain, fever, and skin rashes.
Acute Causes Include:
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Autoimmune kidney disease.
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Medications.
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Dehydration.
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Urinary tract obstruction.
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Untreated systemic diseases like heart or liver disease.
How Is Kidney Impairment Diagnosed?
Kidney function tests:
Blood Tests: Show how well kidneys remove waste from the blood.
Urine Tests: Measure proteins and blood in the urine.
Imaging Tests: Helps to detect abnormalities or blockage in kidneys and surrounding areas.
They are kidney ultrasound, CT urogram, and MRI.
Is Romosozumab Effective Treatment of Patients With Kidney Impairment?
Yes. Romosomab is an effective treatment option for postmenopausal women with osteoporosis and mild-to-moderate reduction in kidney function. Safe to use across different levels of kidney function.
What Precautions Are To Be Taken When Using Romosozumab In Patients With Kidney Impairment?
They are at greater risk of developing hypocalcemia. Therefore, calcium and vitamin D supplements must be given, and serum calcium levels must be monitored.
Conclusion:
Osteoporosis is highly prevalent among patients with kidney impairment. In addition, fractures are a threat to well-being and one’s quality of life. Therefore, physicians and patients with kidney impairment and the general population must have detailed knowledge about the disease so they can contact their physician for help at the earliest. Studies have shown the effectiveness of Romosozumab as the best therapeutic option for treating osteoporosis among patients with kidney impairment.
