Is it safe to continue teriparatide beyond 3 years in a patient with severe osteoporosis and atypical fracture of the femur?

The original label for teriparatide limited its lifetime use to 2 years. Two years is as long as the Phase 3 trial in postmenopausal women had gone when a decision to terminate the trial voluntarily was made by Eli Lilly, due to the finding of osteosarcoma in rats. Thus, the safety data was limited to two years.

As part of the approval agreement, Lilly had to develop a significant post-marketing safety plan. Two large studies were done.

The first was a case finding study in adults with documented osteosarcoma. An independent third party contacted the patients or surviving family members to determine if there had ever been a teriparatide exposure. Later, a second trial was initiated as part of the label change to include GIO as an indication. ...