From the Guidelines
Denosumab should be used with caution in a 100-year-old woman with osteoporosis due to several contraindications and potential adverse effects. The medication is contraindicated in patients with hypocalcemia, which should be corrected before initiating therapy. Major adverse effects include an increased risk of atypical femur fractures and osteonecrosis of the jaw, which are particularly concerning in very elderly patients. Denosumab can also cause significant hypocalcemia, especially in patients with renal impairment, which is common in advanced age. Skin reactions like dermatitis and eczema may occur, and there's an increased risk of infections due to its immunosuppressive effects.
Some of the key points to consider when prescribing denosumab include:
- The risk of falls and subsequent fractures is already elevated in a 100-year-old patient, and denosumab's discontinuation can lead to rebound vertebral fractures, requiring careful consideration of long-term treatment plans.
- The patient's limited life expectancy might affect the benefit-risk assessment, as the fracture prevention benefits of denosumab typically require 12-24 months to manifest.
- Comprehensive baseline assessments including calcium levels, vitamin D status, renal function, and dental health should be performed, with calcium and vitamin D supplementation typically recommended during therapy 1.
- According to the American College of Physicians, denosumab is suggested as a second-line pharmacologic treatment to reduce the risk of fractures in postmenopausal females diagnosed with primary osteoporosis who have contraindications to bisphosphonates 1.
In terms of management, it is essential to:
- Monitor the patient's renal function and calcium levels closely while on denosumab therapy.
- Maintain good oral hygiene and avoid invasive dental surgical procedures while on treatment 1.
- Consider the patient's overall health status, including comorbidities and medications, when making treatment decisions.
- Discuss the importance of adherence to denosumab therapy with the patient, as well as the potential risks and benefits of treatment 1.
From the FDA Drug Label
Do not take Prolia if you: have been told by your doctor that your blood calcium level is too low. are pregnant or plan to become pregnant are allergic to denosumab or any of the ingredients in Prolia. Before taking Prolia, tell your doctor about all of your medical conditions, including if you: are taking a medicine called Xgeva (denosumab). Xgeva contains the same medicine as Prolia. have low blood calcium. cannot take daily calcium and vitamin D had parathyroid or thyroid surgery (glands located in your neck). have been told you have trouble absorbing minerals in your stomach or intestines (malabsorption syndrome). have kidney problems or are on kidney dialysis. are taking medicine that can lower your blood calcium levels. plan to have dental surgery or teeth removed. The most common side effects of Prolia in women who are being treated for osteoporosis after menopause are: back pain pain in your arms and legs high cholesterol muscle pain bladder infection
The contraindications of denosumab in a 100-year-old lady with osteoporosis are:
- Low blood calcium levels
- Pregnancy or planning to become pregnant
- Allergy to denosumab or any of the ingredients in Prolia The adverse effects of denosumab in a 100-year-old lady with osteoporosis may include:
- Back pain
- Pain in arms and legs
- High cholesterol
- Muscle pain
- Bladder infection It is essential to inform the doctor about all medical conditions, including kidney problems, malabsorption syndrome, and plans for dental surgery, before taking denosumab 2. Additionally, the risk of infection, including serious infections, should be considered when taking denosumab 2.
From the Research
Contraindications and Adverse Effects of Denosumab
- Denosumab is a medication used to treat osteoporosis, but it can have adverse effects, particularly in older adults 3, 4.
- Hypocalcemia is a common adverse effect of denosumab, with reported rates ranging from 0.05% to 7.4% in postmenopausal women with osteoporosis 3, 4.
- Predictors of hypocalcemia in patients treated with denosumab include low pretreatment serum calcium and creatinine levels, as well as elevated parathyroid hormone levels 3, 4.
- Serum calcium monitoring is recommended to identify and prevent severe hypocalcemia, especially in high-risk patients 4.
- Other potential adverse effects of denosumab include:
- Skin reactions
- Musculoskeletal pain
- Cellulitis
- Endocarditis
- Osteonecrosis of the jaw
- Contraindications for denosumab use include:
- Hypocalcemia
- Pregnancy
- Breastfeeding
- Severe renal impairment
Special Considerations for a 100-Year-Old Lady with Osteoporosis
- The risk of hypocalcemia and other adverse effects may be higher in older adults due to age-related declines in renal function and other comorbidities 5.
- Careful monitoring of serum calcium levels and renal function is recommended in older adults treated with denosumab 5.
- The benefits and risks of denosumab treatment should be carefully weighed in older adults, taking into account individual factors such as fracture risk, renal function, and overall health status 6, 7.