Effect of teriparatide on bone mineral density and biochemical markers in Japanese women with postmenopausal osteoporosis: a 6-month dose-response study

Abstract

The dose-response efficacy and safety with three doses of teriparatide and placebo was assessed, using once-daily subcutaneous injections for 24 weeks, in Japanese postmenopausal women with osteoporosis at high risk of fracture for reasons of preexisting fracture(s), advanced age, and/or low bone mineral density (BMD). In this multicenter, randomized, placebo-controlled study, 159 subjects were randomized and 154 subjects were included for analysis. Teriparatide (10-microg, 20-microg, and 40-microg doses) showed a statistically significant increase with increasing treatment dose as assessed by the percent change of lumbar spine BMD from baseline to endpoint using Williams' test when compared with placebo (P < 0.001). The mean (+/-SD) percent change in lumbar spine, femoral neck, and total hip BMD with the 20-microg dose from baseline to endpoint was 6.40% +/- 4.76%, 1.83% +/- 7.13%, and 1.91% +/- 3.60%, respectively. Rapid and sustained increases in bone formation markers [type I procollagen N-terminal propeptide (PINP), type I procollagen C-terminal propeptide (PICP), and bone-specific alkaline phosphatase (BAP)], followed by late increases in a bone resorption marker [type I collagen cross-linked C-telopeptide (CTX)], were observed for the teriparatide treatment groups (20-microg, 40-microg), suggesting a persistent, positive, balanced anabolic effect of teriparatide. Optimal adherence was achieved by this daily self-injection treatment. Regarding safety, most of the adverse events were mild to moderate in severity. No study drug-or study procedure-related serious adverse events were reported during the treatment period. These results observed in Japanese patients may support the observation that teriparatide stimulates bone formation in patients with osteoporosis at a high risk of fracture.

Evaluation of the anti-osteoporotic effect of Ginkgo biloba L. in Wistar rats with glucocorticoid-induced-osteoporosis by bone densitometry using dual-energy x-ray absorptiometry (DEXA) and mechanical testing

“…A relevant finding was that the EGb increased significantly the levels of BAP (figure 1), and such increase is a response to an anabolic therapy (Miyauchi et al 2008) that is directly linked with osteoblastic activity (Duque and Rivas 2007). In accordance with the present study results, studies in vitro showed that Ginkgo biloba (100µg/ml) increased alkaline phosphatase levels in 147.2% when compared to the culture of control cells.…”

The Assessment of Fracture Risk

“…The least significant change, defined as a difference reflecting a real change with a 5% chance of type-1 error (false positive), is approximately 25% to 30% for serum markers and 50% to 60% for urine markers 66 . After treatment with an anabolic agent, levels of bone formation markers increase substantially within four weeks and levels of bone resorption markers increase later, approximately three months following the initial therapy 84,85 .…”

Teriparatid [paratiroid hormon (1-34)] ve diş hekimliği

“…9 Miyauchi ve ark. 34 yaptığı bir çalışmada, teriparatidin osteoporozlu kadınlarda kemik belirteçleri üzerine etkileri araştırılmıştır. Bu çalışmada 3 ayrı teriparatid dozu (10 µg, 20 µg ve 40 µg) uygulanmıştır.…”