An 18-month open-label trial of teriparatide in patients with previous parathyroidectomy at continued risk for osteoporotic fractures: an exploratory study.

OBJECTIVE

To determine whether teriparatide increases lumbar spine bone mineral density (BMD) in patients who have undergone parathyroidectomy for primary hyperparathyroidism (PHPT) and are at continued risk for fracture.

METHODS

This open-label, nonrandomized, uncontrolled exploratory design study included patients who had undergone parathyroidectomy for PHPT and were judged to be at continued risk for fracture according to National Osteoporosis Foundation criteria. Patients were administered teriparatide subcutaneously, 20 mcg daily, for 18 months after they satisfactorily completed the screening period to ensure their eligibility for study participation. BMD was assessed by dual-energy x-ray absorptiometry at baseline, 6 months, 12 months, and 18 months. Secondary objectives included efficacy of teriparatide on increasing hip BMD, incidence of fractures, and safety measurements.

RESULTS

Seven women and 3 men were included. Change in mean lumbar spine BMD was 0.059 gm/cm2, which is a 7.1% increase (P = .005). Change in mean femoral neck BMD was 0.019 gm/cm2, which is a nonsignificant increase of 3.3% (P = .49). There was no incidence of fractures. There were no significant changes in the safety measurements.

CONCLUSIONS

The use of teriparatide in patients with PHPT who have undergone parathyroidectomy and are still at risk for fracture is effective in improving lumbar spine BMD without deleterious effects on safety. Teriparatide should therefore be considered as a viable alternative for the treatment of these patients, as it may help in the prevention of fractures and their complications.