What patient education and monitoring schedule (including labs, DEXA scans, and follow‑up visits) should be provided for a postmenopausal woman with osteoporosis who is starting raloxifene (Evista)?

Patient Education and Monitoring for Raloxifene (Evista) in Postmenopausal Osteoporosis

Educate patients starting raloxifene 60 mg daily about the critical warning signs of venous thromboembolism (leg pain, swelling, sudden chest pain, shortness of breath) and stroke (sudden weakness, vision changes, speech difficulty), and instruct them to discontinue the medication immediately and seek emergency care if these occur. 1

Critical Safety Education

Thromboembolic Risk

• Inform patients that raloxifene increases the risk of deep venous thrombosis (0.7% vs 0.2% placebo) and pulmonary embolism (0.3% vs 0.1% placebo), with an overall relative risk of 3.1 for venous thromboembolism. 1
• Instruct patients to discontinue raloxifene at least 72 hours before and during prolonged immobilization (surgery, extended travel, bed rest) and not resume until fully mobile. 1
• Raloxifene is absolutely contraindicated in women with prior history of DVT, PE, stroke, or transient ischemic attack. 1

Stroke Risk

• The RUTH trial demonstrated an increased risk of fatal stroke (HR 1.49) in postmenopausal women with cardiovascular risk factors. 1, 2
• Educate patients about stroke warning signs: sudden numbness, confusion, vision problems, severe headache, or difficulty walking. 2

Common Side Effects

• Hot flashes, leg cramps, peripheral edema, and influenza-like symptoms occur commonly but typically diminish after the first few months of therapy. 1, 2
• These symptoms were observed during initial treatment in the MORE trial but not during the additional 4 years in the CORE trial, suggesting early adaptation. 1

Monitoring Schedule

Baseline Assessment (Before Starting)

• Obtain baseline DEXA scan of lumbar spine and hip to document bone mineral density. 1
• Screen for contraindications: history of thromboembolic disease, stroke, TIA, or prolonged immobilization risk. 1
• Assess breast cancer risk using the Gail model (raloxifene provides dual benefit if 5-year risk ≥1.66%). 1, 2

Laboratory Monitoring

• No routine laboratory monitoring is required for raloxifene therapy beyond standard osteoporosis management. 1
• Unlike tamoxifen, raloxifene does not require endometrial surveillance as it shows no endometrial stimulation. 1
• Lipid panels may be obtained as raloxifene reduces total and LDL cholesterol without affecting HDL or triglycerides. 1, 3

DEXA Scan Frequency

• Repeat DEXA scan at 2 years after initiating therapy to assess treatment response (expected increase of 2.1-2.6% at femoral neck and 2.6-2.7% at spine). 1, 4, 3
• Subsequently, perform DEXA scans every 2 years while on therapy to monitor bone density trends. 1

Clinical Follow-Up Visits

• Schedule follow-up at 3 months to assess tolerance, review side effects (particularly hot flashes and leg cramps), and reinforce safety education. 1
• Routine visits every 6-12 months to monitor adherence, assess for new fractures, review thromboembolic risk factors, and ensure calcium (1000-1200 mg/day) and vitamin D (800-1000 IU/day) supplementation. 1, 5

Treatment Duration and Efficacy

Duration of Therapy

• Raloxifene is approved for 5 years for breast cancer risk reduction, but may be continued longer in women with osteoporosis where fracture prevention is the primary goal. 1
• The MORE and CORE trials demonstrated sustained benefit over 8 years of treatment. 1

Expected Outcomes

• Raloxifene reduces vertebral fracture risk by 30-55% depending on baseline fracture status but has NOT been shown to reduce non-vertebral or hip fractures. 1, 2, 4
• Post-hoc analyses suggest non-spine fracture reduction only in high-risk subjects. 6
• Raloxifene reduces invasive ER-positive breast cancer risk by 66-76% over 8 years but has no effect on ER-negative cancers. 1

Critical Clinical Caveats

When NOT to Use Raloxifene

• Do not use raloxifene in women with established breast cancer history due to concerns about cross-resistance and limited anti-tumor activity after tamoxifen exposure. 5, 2
• Raloxifene is contraindicated in premenopausal women (causes decreased BMD in this population). 1, 2
• Avoid in women requiring vasomotor symptom relief, as hot flashes may be accentuated. 1, 2

Comparative Considerations

• Raloxifene is less potent than bisphosphonates for comprehensive fracture prevention, particularly for non-vertebral and hip fractures. 1, 5, 2
• For women with breast cancer history requiring osteoporosis treatment, bisphosphonates are preferred first-line agents. 5

Medication Interactions

• Unlike tamoxifen, raloxifene does not require CYP2D6 consideration for drug interactions. 1
• Do not combine raloxifene with hormone therapy. 1

Patient Counseling on Benefits

• Emphasize the dual benefit for appropriate candidates: vertebral fracture reduction AND 66% reduction in invasive ER-positive breast cancer risk over 8 years. 1, 2
• Number needed to treat: 93 women for 4 years to prevent one case of invasive breast cancer. 2
• Raloxifene does not increase endometrial cancer risk, unlike tamoxifen. 1