Sustained nonvertebral fragility fracture risk reduction after discontinuation of teriparatide treatment.
A follow-up in 1262 women was conducted after the discontinuation of teriparatide. The hazard ratio for combined teriparatide group (20 and 40 microg) for the 50-month period after baseline was 0.57 (p = 0.002), suggesting a sustained effect in reducing the risk of nonvertebral fragility fracture.


BACKGROUND
Treatment with teriparatide [rhPTH(1-34)] 20 and 40 microg once-daily subcutaneous dosing significantly reduced the risk of nonvertebral fragility fractures over a median exposure of 19 months.


METHODS
All participants in the Fracture Prevention Trial were invited to participate in a follow-up study. Prior treatment assignments were revealed, and patients were able to receive osteoporosis treatments without restriction.


RESULTS
Approximately 60% of the 1262 patients received an osteoporosis treatment at some time during follow-up, with greater use in the former placebo group than in the combined former teriparatide group (p < 0.05). The hazard ratios for nonvertebral fragility fractures in each teriparatide group relative to placebo were statistically significant for the 50-month period including treatment and follow-up (p < 0.03). In the follow-up period, the hazard ratio was significantly different between the 40 mug and combined groups versus placebo but not for the 20 microg group versus placebo. However, the 20 and 40 microg groups were not different from each other. Kaplan-Meier analysis of time to fracture showed that the fracture incidence in the former placebo and teriparatide groups diverged during the 50-month period including teriparatide treatment and follow-up (p = 0.009). Total hip and femoral neck BMD decreased in teriparatide-treated patients who had no follow-up treatment; BMD remained stable or further increased in patients who received a bisphosphonate after teriparatide treatment.


CONCLUSIONS
While the study design is observational, the results support a sustained effect of teriparatide in reducing the risk of nonvertebral fragility fractures up to 30 months after discontinuation of treatment.
Prince
Richard
R
Department of Endocrinology and Diabetes and University of Western Australia, Sir Charles Gairdner Hospital, Nedlands, Australia.
Sipos
Adrien
A
Hossain
Anwar
A
Syversen
Unni
U
Ish-Shalom
Sophia
S
Marcinowska
Ewa
E
Halse
Johan
J
Lindsay
Robert
R
Dalsky
Gail P
GP
Mitlak
Bruce H
BH
D000368:Aged; D000704:Analysis of Variance; D015519:Bone Density; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004164:Diphosphonates / Q000378:metabolism; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D017102:Fracture Healing; D050723:Fractures, Bone / Q000517:prevention & control*; D006615:Hip / Q000473:pathology; D006801:Humans; D008875:Middle Aged; D010024:Osteoporosis; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy*; D010919:Placebos; D016016:Proportional Hazards Models; D012306:Risk; D019379:Teriparatide / Q000008:administration & dosage / Q000627:therapeutic use*; D013997:Time Factors
D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D010919:Placebos; D019379:Teriparatide