What are the warnings and precautions for spontaneous hip or thigh fracture in patients with osteoporosis?

From the Guidelines

Patients with osteoporosis should be aware of the warning signs of spontaneous hip or thigh fractures, including persistent thigh or groin pain, and immediately contact their healthcare provider if symptoms develop. These atypical femoral fractures are rare but serious complications associated with long-term bisphosphonate use (medications like alendronate, risedronate, ibandronate, and zoledronic acid) 1. Some key points to consider include:

• Patients taking these medications for more than 3-5 years are at higher risk, particularly those on concurrent glucocorticoid therapy.
• Bisphosphonate therapy should be periodically reassessed, with consideration of a drug holiday after 3-5 years for moderate-risk patients and after 5-10 years for high-risk patients.
• Weight-bearing exercise, adequate calcium and vitamin D intake, smoking cessation, and limiting alcohol consumption are important preventive measures.
• The American College of Physicians recommends that clinicians offer pharmacologic treatment with alendronate, risedronate, zoledronic acid, or denosumab to reduce the risk for hip and vertebral fractures in women who have known osteoporosis 1.
• The EULAR/EFORT recommendations suggest that pharmacological treatment should preferably use drugs that have been demonstrated to reduce the risk of vertebral, non-vertebral and hip fractures, and should be regularly monitored for tolerance and adherence 1.
• A recent evidence-based guideline for the management of osteoporosis in men highlights the importance of treatment for men at high risk of fracture, including those with a history of fragility fracture of the hip or vertebra, and recommends bisphosphonates as a first-line treatment option 1.

From the FDA Drug Label

Atypical Subtrochanteric and Diaphyseal Femoral Fractures Advise patients to report new or unusual thigh, hip, or groin pain [see Warnings and Precautions (5.5)].

The warning for spontaneous hip or thigh fracture is to advise patients to report new or unusual thigh, hip, or groin pain. This is due to the risk of atypical subtrochanteric and diaphyseal femoral fractures associated with denosumab (Prolia) treatment 2. Patients should be informed to seek medical attention if they experience any of these symptoms. Key points to consider:

• Report new or unusual thigh, hip, or groin pain
• Risk of atypical subtrochanteric and diaphyseal femoral fractures
• Seek medical attention if symptoms occur 2

From the Research

Warnings and Precautions for Spontaneous Hip or Thigh Fracture

• Spontaneous hip or thigh fracture is a significant concern in patients with osteoporosis, as it can lead to increased morbidity and mortality 3, 4.
• Patients with osteoporosis are at a higher risk of fractures, and any new fracture in an adult aged 50 years or older signifies an elevated risk for subsequent fractures 4.
• The risk of fractures can be reduced with effective antifracture medication, lifestyle changes, and other interventions 3, 4.
• Healthcare providers should identify patients at risk of fractures and initiate proven osteoporosis interventions, including bone densitometry and pharmacologic therapy 4.

Risk Factors for Spontaneous Hip or Thigh Fracture

• Decreased bone mineral density is a significant risk factor for hip fractures 5.
• Other risk factors include reduced level of activity, chronic medication use, and falls 5.
• Patients with hip fractures often experience pain in the groin and are unable to bear weight on the affected extremity 5.

Prevention and Treatment of Spontaneous Hip or Thigh Fracture

• Prevention of fractures includes lifestyle changes, such as weight-bearing and resistance-training exercise, adequate intake of calcium and vitamin D, and avoidance of smoking and excessive alcohol intake 3, 4.
• Treatment of osteoporosis may include antiresorptive agents, such as bisphosphonates, and anabolic agents, such as teriparatide 3, 6.
• Patients with hip fractures should receive prophylactic antibiotics and thromboembolic prophylaxis, and rehabilitation is critical to long-term recovery 5.
• Bisphosphonate therapy can be used to reduce the risk of another hip fracture in patients with a history of hip fracture 5.