Teriparatide Treatment Protocol for Osteoporosis
Recommended Dosing and Administration
Administer teriparatide 20 mcg subcutaneously once daily into the thigh or abdominal region for a maximum duration of 24 months, followed by mandatory transition to bisphosphonate therapy to prevent rapid bone loss. 1, 2
Initial Administration Protocol
- Administer the first dose under circumstances where the patient can sit or lie down, as transient orthostatic hypotension may occur with initial doses 1
- Ensure supplemental calcium and vitamin D based on individual patient needs 1
- The medication comes as 620 mcg/2.48 mL (250 mcg/mL) in a single-patient-use pen containing 28 daily doses of 20 mcg 1
Patient Selection Criteria
High-Risk Patients Who Should Receive Teriparatide
Reserve teriparatide specifically for postmenopausal women and men with osteoporosis at very high risk for fracture, defined as: 3, 2
- Recent fracture within the past 12 months 3, 2
- History of multiple clinical osteoporotic fractures 3, 2
- Failure of or intolerance to other available osteoporosis therapies (bisphosphonates, denosumab) 3, 2, 1
- Multiple risk factors for fracture in patients typically >74 years of age 3, 2
Glucocorticoid-Induced Osteoporosis
For adults ≥40 years at moderate-to-high risk of fracture on chronic glucocorticoid therapy, use teriparatide only when bisphosphonates (oral or IV) are not appropriate due to comorbidities, patient preference, or adherence concerns 4
Absolute Contraindications
Do not use teriparatide in patients with: 1
- Hypersensitivity to teriparatide or any excipients 1
- Open epiphyses (pediatric patients) 1
- Metabolic bone diseases including Paget's disease 1
- Bone metastases or history of skeletal malignancies 1
- Prior external beam or implant radiation therapy involving the skeleton 1
- Hereditary disorders predisposing to osteosarcoma 1
- Known underlying hypercalcemic disorders 1
Relative Contraindications Requiring Risk-Benefit Assessment
- Active or recent urolithiasis (risk of exacerbation due to transient hypercalcemia) 1
- Worsening of previously stable cutaneous calcification (discontinue if this develops) 1
Treatment Duration and Sequential Therapy
The 24-Month Rule
Limit teriparatide treatment to a maximum of 24 months during a patient's lifetime, unless the patient remains at or has returned to having high risk for fracture. 1, 2, 5
The rationale for the full 24-month course: 5
- Fracture risk reduction appears to increase with longer duration of therapy 5
- Both remodeling-based and modeling-based bone formation contribute to anti-fracture efficacy throughout the treatment period 5
- Shorter courses have not been validated in controlled trials for fracture prevention 5
Mandatory Follow-Up Antiresorptive Therapy
Immediately transition to bisphosphonate therapy after completing teriparatide to maintain bone density gains and prevent rebound vertebral fractures. 3, 2
Discontinuation without follow-up antiresorptive therapy results in rapid bone loss, negating the benefits achieved during teriparatide treatment 2
Expected Efficacy Outcomes
Fracture Risk Reduction
Teriparatide reduces: 2
- Any clinical fractures by 27 fewer events per 1000 patients (high certainty) 2
- Radiographic vertebral fractures by 69 fewer events per 1000 patients (high certainty) 2
- Clinical vertebral fractures by 45 fewer events per 1000 patients (low certainty) 2
Bone Mineral Density Improvements
At 24 months of treatment, expect BMD increases of: 6
- Lumbar spine: approximately 13% from baseline 6
- Femoral neck: approximately 3% from baseline 6
- Total hip: approximately 4% from baseline 6
Bone Turnover Marker Response
Serum procollagen I N-terminal propeptide (PINP) increases rapidly within 1 month of treatment initiation, with median increases of approximately 79% at 12 months, indicating robust bone formation 6, 7
Safety Monitoring and Common Adverse Events
Most Common Adverse Reactions (>10%)
Serious Adverse Events
Only 0.32% of patients report serious adverse drug reactions, most commonly nausea 7
Drug Interactions
Monitor patients on digoxin closely, as transient hypercalcemia induced by teriparatide may predispose to digitalis toxicity. 1
Treatment Hierarchy and Cost Considerations
When to Choose Teriparatide Over Romosozumab
Select teriparatide when the patient has recent cardiovascular events (myocardial infarction or stroke within the past year) or significant cardiovascular disease, as romosozumab increases cardiovascular events (HR 1.9,95% CI 1.1-3.1). 3
Cost Reality
Teriparatide is the most expensive osteoporosis treatment at $22,156 average annual cost per Medicare beneficiary, compared to romosozumab at $5,574 3. However, self-administration capability may reduce overall treatment costs compared to infusion-based therapies 3
Position in Treatment Algorithm
Bisphosphonates remain first-line therapy for osteoporosis due to more favorable balance among benefits, harms, patient values, preferences, and cost 3. Teriparatide is reserved for patients with severe osteoporosis who have failed or are intolerant to bisphosphonates 2
Special Populations
Pregnancy and Lactation
- Consider discontinuing teriparatide when pregnancy is recognized 1
- Breastfeeding is not recommended during teriparatide treatment 1
Pediatric Use
Safety and effectiveness not established; avoid use due to increased baseline risk of osteosarcoma in patients with open epiphyses 1
Women of Childbearing Potential
For women meeting high-risk criteria who do not plan pregnancy within the treatment period and use effective birth control, teriparatide may be used if oral bisphosphonates are not appropriate 4
Treatment Persistence
Real-world data shows persistence rates of 60.8% at 18 months and 39.1% at 24 months 7. Emphasize to patients the importance of completing the full 24-month course for maximum fracture risk reduction 5