The safety of Teriparatide has been evaluated in 24 clinical trials that enrolled over 2800 women and men. Four long-term, Phase 3 clinical trials included one large placebo-controlled, double-blind multicentre trial with 1637 postmenopausal women, one placebo-controlled, double-blind multicentre trial with 437 men, and two active-controlled trials including 393 postmenopausal women. Teriparatide doses ranged from 5 to 100 mcg/day in short-term trials and 20 to 40 mcg/day in the long-term trials. A total of 1943 of the patients studied received Teriparatide, including 815 patients at 20 mcg/day and 1107 patients at 40 mcg/day. In the long-term clinical trials, 1137 patients were exposed to Teriparatide for greater than 1 year (500 at 20 mcg/day and 637 at 40 mcg/day). The maximum exposure duration to Teriparatide was 2 years. Adverse events associated with Teriparatide (rDNA origin) injection usually were mild and generally did not require discontinuation of therapy.
The safety of Teriparatide has also been evaluated in a Phase 3 randomized, double blind, double-dummy, active controlled clinical trial that enrolled 428 men and women with glucocorticoid induced osteoporosis. Patients received either Teriparatide 20 mcg/day plus oral placebo (n=214) or Alendronate 10 mg/day plus injectable placebo (n=214).
Adverse Events in Placebo-Controlled Clinical Trials (Irrespective of Causality)a
|Body System / Adverse events||% of patients|
|Terifrac (N=691)||Placebo (N=691)|
|Body as a whole|
|Skin and appendages|