Is history of radiation therapy for uterine cancer an absolute contraindication to parathyroid hormone/parathyroid hormone related protein analogues such as teriparatide and abaloparatide in a patient with severe osteoporosis with multiple spine fractures?

I agree with Dr. @Dr. First Last. The initial studies in young rats given high doses of PTH compounds for most of their lifespan (I think until either 24 or 36 months of age) resulted in a higher-than-expected number of incident osteosarcomas. However, the black box warning about skeletal radiation and contraindications for PTH use was the result of earlier work that found skeletal radiation increased osteosarcoma risk, especially in children before their growth plates fuse. The PTH label reflected in this risk, however post-marketing surveillance data for 15 years did not show any increased risk in adults. So while the label has not changed, I believe we can, with some confidence, treat the patient with PTH. However, the patient should sti...

There is no doubt that the two approved PTH anabolic drugs increase osteosarcoma in rats. As part of the approval agreement for Forteo, Lilly embarked on a very well-planned post-marketing safety study looking at patients with osteosarcoma and a prospective study with patients starting Forteo.

This work over about 15 years is summarized recently by Krege et al. FDA was satisfied with the data and eventually lifted the box warning regarding osteosarcoma.

The information remains in the label and the clinician has to weigh risk vs benefit. The risk appears to be quite low but the clinician should have a factual discussion with the patient and make a joint decision.