Effects of teriparatide on bone mineral density and bone turnover markers in
Japanese subjects with osteoporosis at high risk of fracture in a 24-month
clinical study: 12-month, randomized, placebo-controlled, double-blind and
12-month open-label phases.
Author(s): Miyauchi A, Matsumoto T, Sugimoto T, Tsujimoto M, Warner MR, Nakamura T.
Affiliation(s): Lilly Research Laboratories Japan, Eli Lilly Japan K.K., Sannomiya Plaza Bldg.,
7-1-5 Isogamidori, Chuo-ku, Kobe 651-0086, Japan. akimiyauchi0129@gmail.com
Publication date & source: 2010, Bone. , 47(3):493-502
This multicenter study assessed the safety and efficacy of teriparatide 20
microg/day in Japanese men and women with osteoporosis at high risk of fracture
during a 12-month, randomized, double-blind, placebo-controlled treatment period
followed by second and third treatment periods (to 18 and 24 months,
respectively,) in which all subjects received open-label teriparatide. Subjects
(93% female; median age 70 years) were randomized 2:1 to teriparatide versus
placebo (randomized at baseline, teriparatide n=137, placebo-teriparatide n=70;
entering the second period, teriparatide n=119, placebo-teriparatide n=59;
entering the third period, teriparatide n=102, placebo-teriparatide n=50). For
subjects with measurements at 12 months, teriparatide significantly increased
bone mineral density (BMD) at the lumbar spine L2-L4 (mean percent change+/-SD,
teriparatide 10.04+/-5.23% versus placebo-teriparatide 0.19+/-4.33%), the femoral
neck (teriparatide 2.01+/-4.63% versus placebo-teriparatide 0.44+/-3.97%), and
the total hip (teriparatide 2.72+/-4.04% versus placebo-teriparatide
-0.26+/-3.42%). In the placebo-teriparatide group at 24 months (12-month
teriparatide dosing) BMD increased by 9.11+/-5.14% at the lumbar spine,
2.19+/-4.81% at the femoral neck and 2.46+/-3.54% at the total hip. In the
teriparatide group at 18 and 24 months, BMD increased from baseline at the lumbar
spine by 11.93+/-5.79% and 13.42+/-6.12%, respectively; at the femoral neck by
2.68+/-4.45% and 3.26+/-4.25%, respectively; and at the total hip by 3.02+/-3.79%
and 3.67+/-3.98%, respectively. Serum procollagen I N-terminal pro-peptide (PINP)
increased rapidly with teriparatide treatment (P<0.001 versus placebo at 1 month)
and changed from baseline in the teriparatide and placebo-teriparatide groups at
12 months by a median of 78.95% and -17.23%, respectively, (P<0.001) and at 24
months by 49.24% and 76.12%, respectively. The incidence of treatment-emergent
adverse events (TEAEs), serious TEAEs, and discontinuations due to TEAEs were
comparable in the teriparatide and placebo-teriparatide groups. These data show
that teriparatide 20 microg/day was well tolerated and stimulated bone formation
in Japanese subjects with osteoporosis at high risk of fracture during 18 and 24
months of treatment.
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