Two years of treatment with cyclic teriparatide yielded improvements in bone mineral density (BMD) that were similar to those seen with daily teriparatide, new data published in the Journal of Clinical Endocrinology & Metabolism indicate.
Intermittent 3-month cyclic administration of teriparatide (parathyroid hormone 1-34) may optimize the anabolic potential of teriparatide, according to the researchers. To see how cyclic administration stacked up against daily administration, they compared the two in both patients who have and those who have not been pretreated with alendronate.
In the study, the researchers randomly assigned 150 postmenopausal women with osteoporosis — 86 treatment-naïve patients (mean age, 67.4 year) and 64 alendronate-treated patients (mean age, 63.4 years) — to daily teriparatide for 24 months or four 3-month teriparatide cycles, followed by 3 months off treatment.
BMD at 24 months served as the main outcome measure.
In treatment-naïve patients, BMD increased at the lumbar spine, total hip, trochanter and femoral neck for patients in both the daily teriparatide and the cyclic teriparatide groups (increments within groups, P<.0002 for all, except cyclic femoral neck, P=.13), according to the data.
However, results also revealed approximately two-fold greater increases in BMD in the daily teriparatide group vs. the cyclic teriparatide group at the lumbar spine (8.8% vs. 4.8%), total hip (4.0% vs. 2.1%), trochanter (5.6% vs. 3.1%) and femoral neck (2.9% vs. 1.2%; group differences, all P<.05).
Additionally, radius BMD decreased more in the daily teriparatide group, as compared with the cyclic teriparatide group (–4.2% vs. –2.1%; group difference, P=.08) in treatment-naïve patients. Total bone mineral also modestly increased in both the daily (1.4%; P=.18) and cyclic teriparatide groups (1.5%; P=.06).
In the women treated with alendronate, the researchers observed similar increases in BMD in both the daily and cyclic teriparatide groups at the lumbar spine (7.5% and 6.0%), total hip (3% and 2.5%), trochanter (3.7% and 3.3%) and femoral neck (3% and 1.5%; within groups, P<.003, except cyclic femoral neck, P=.02).
Declines in radius BMD were noted in the daily teriparatide (–0.7%; nonsignificant) and cyclic teriparatide groups (–1.4%; P<.05), while total bone mineral increased by 2.3% and 3% in the daily and cyclic groups, respectively (P<.001 for both).
“In conclusion, we are still learning how to optimize anabolic and antiresorptive therapies in sequence and/or in combination to achieve the best outcomes for patients with severe osteoporosis,” the researchers wrote.
“The cyclic approach is valid for those on ongoing oral alendronate and might apply to those on bisphosphonates. However, there does not appear to be a BMD advantage (superior BMD gain for total cumulative [teriparatide] dose) to cyclic administration in women on no antiresorptive therapy for at least up to 24 months.”