From the Guidelines
Bisphosphonates, specifically pamidronate, are the most effective treatment for Paget's disease, as they inhibit osteoclastic bone resorption and have been shown to preserve bone mass and prevent fractures 1.
Treatment Options
- Bisphosphonates: pamidronate, etidronate, and alendronate are effective in treating Paget's disease by inhibiting osteoclastic bone resorption 1.
- Calcitonin: a naturally occurring hormone that inhibits osteoclast action and has been shown to protect bone mass in Paget's disease, although its use is limited by the need for injection or nasal administration 1.
Dosage and Administration
- Pamidronate: a single injection can sustain effects for months, making it a promising treatment option for Paget's disease 1.
- Alendronate: available in oral form, but requires careful administration to avoid esophageal irritation 1.
Additional Considerations
- Calcium and vitamin D supplements should accompany bisphosphonate therapy to prevent hypocalcemia.
- Pain management with NSAIDs or acetaminophen may be necessary to control symptoms.
- Regular follow-up with alkaline phosphatase measurements every 6-12 months helps monitor treatment effectiveness and disease activity.
From the FDA Drug Label
14.5 Treatment of Paget's Disease of Bone The efficacy of alendronate sodium 40 mg once daily for six months was demonstrated in two double-blind clinical studies of male and female patients with moderate to severe Paget's disease (alkaline phosphatase at least twice the upper limit of normal) 2.5 Treatment of Paget's Disease of Bone The recommended treatment regimen is 40 mg once a day for six months. Re-treatment of Paget's Disease Re-treatment with alendronate sodium tablets, may be considered, following a six-month post-treatment evaluation period in patients who have relapsed, based on increases in serum alkaline phosphatase, which should be measured periodically Re-treatment may also be considered in those who failed to normalize their serum alkaline phosphatase. 1.5 Treatment of Paget's Disease of Bone Alendronate sodium tablets, USP are indicated for the treatment of Paget's disease of bone in men and women. Treatment is indicated in patients with Paget's disease of bone who have alkaline phosphatase at least two times the upper limit of normal, or those who are symptomatic, or those at risk for future complications from their disease.
The treatment for Paget's disease is alendronate sodium 40 mg once a day for six months 2, 2, 2.
- The recommended treatment regimen is 40 mg once a day for six months.
- Re-treatment with alendronate sodium may be considered after a six-month post-treatment evaluation period in patients who have relapsed.
- Alendronate sodium is indicated for the treatment of Paget's disease of bone in men and women who have alkaline phosphatase at least two times the upper limit of normal, or those who are symptomatic, or those at risk for future complications from their disease.
From the Research
Treatment Options for Paget's Disease
- Treatment with a potent bisphosphonate is indicated in patients with Paget's disease who have symptoms likely to respond to reduced bone turnover at pagetic sites 3
- Biochemical remission is achievable in a majority of patients with pamidronate, alendronate, risedronate, or zoledronic acid 3
- The treatment of choice is a potent nitrogen-containing bisphosphonate, including oral alendronate or risedronate or intravenous pamidronate or zoledronic acid 3
Efficacy of Zoledronic Acid
- A single infusion of zoledronic acid 5 mg is associated with normalization of serum alkaline phosphatase in 89% of patients and a prolonged biochemical remission 3
- Zoledronic acid produces more rapid, more complete, and more sustained responses in Paget's disease than does daily treatment with risedronate 4
- 96% of patients treated with a one-time intravenous treatment of zoledronic acid 5 mg achieved therapeutic response, compared with 74% treated with 60 days of daily oral treatment with risedronate 30 mg 4, 5
Low-Dose Bisphosphonate Therapy
- Remission can be achieved with once-weekly, "osteoporosis doses" of alendronate or risedronate in a large proportion of "real world" PDB patients 6
- 84% of treatment courses with alendronate 70 mg/week achieved remission, and 90% of those who did not achieve remission subsequently responded to 140 mg/week 6
Side Effects and Considerations
- Side effect profiles with alendronate and risedronate include esophageal irritation in a minority of patients 3
- Intravenous pamidronate and zoledronic acid may induce an acute phase reaction with fever and flu-like symptoms with the first dose, primarily in patients who are treatment naïve to nitrogen-containing bisphosphonates 3
- Calcium and vitamin D repletion are mandatory with these potent anti-osteoclast therapies to avoid hypocalcemia 3