ABSTRACT: Context: Weekly teriparatide injection at a dose of 56.5 μg has been shown to increase bone mineral density. Objective: A phase 3 study was conducted to determine the efficacy of once-weekly teriparatide injection for reducing the incidence of vertebral fractures in patients with osteoporosis. Design and Setting: In this randomized, multicenter, double-blind, placebo-controlled trial conducted in Japan, the incidence of morphological vertebral fractures by radiographs was assessed. Patients: Subjects were 578 Japanese patients between the ages of 65 and 95 yr who had prevalent vertebral fracture. Intervention: Subjects were randomly assigned to receive once-weekly sc injections of teriparatide (56.5 μg) or placebo for 72 wk. Main Outcome Measure: The primary endpoint was the incidence of new vertebral fracture. Results: Once-weekly injections of teriparatide reduced the risk of new vertebral fracture with a cumulative incidence of 3.1% in the teriparatide group, compared with 14.5% in the placebo group (P < 0.01), and a relative risk of 0.20 (95% confidence interval, 0.09 to 0.45). At 72 wk, teriparatide administration increased bone mineral density by 6.4, 3.0, and 2.3% at the lumbar spine, the total hip, and the femoral neck, respectively, compared with the placebo (P < 0.01). Adverse events (AE) and the dropout rates by AE were more frequently experienced in the teriparatide group, but AE were generally mild and tolerable. Conclusion: Weekly sc administration of teriparatide at a dose of 56.5 μg may provide another option of anabolic treatments in patients with osteoporosis at higher fracture risk.
The Journal of clinical endocrinology and metabolism 06/2012; 97(9):3097-106. · 6.50 Impact Factor
ABSTRACT: Menatetrenone (2-methyl 1,3-tetraprenyl-1,4-naphtoquinone; vitamin K2) is a vitamin K homolog. To evaluate its efficacy on cortical bone mineral density and its safety, a 24-week double-blind
placebo-controlled study was conducted by enrolling 80 osteoporotic patients. Patients were given either 90 mg/day of vitamin
K2 (n = 39) or a placebo (n = 41). Bone density was assessed on the X-ray film of the right second metacarpal bone using the microdensitometric method.
In the vitamin K2 group, bone density increased by 2.20% ± 2.48% from the baseline; in the placebo group, it decreased by −7.31% ± 3.65% (P = .037, K2
vs placebo). Urinary excretion of γ-carboxyglutamic acid (Gla) significantly increased from 72.61 ± 4.08 nmole/mg creatinine
before treatment to 88.36 ± 5.35 in the 24th week after completion of the vitamin K2 treatment (P = .008). In the placebo group, there were no significant changes in urinary Gla excretion. In the 24th week of the treatment,
the urinary calcium/creatinine ratio in the vitamin K2 group decreased from 0.137 ± 0.018 to 0.118 ± 0.016; in the placebo group, it increased from 0.153 ± 0.018 to 0.189 ± 0.029.
As a result, the 24-week levels in the vitamin K2 and placebo groups became significantly different (P = .028). There were a few adverse effects attributable to vitamin K2. Our findings suggest that vitamin K2 at a dosage of 90 mg/day is effective in maintaining peripheral cortical bone density and is safe in treatment for osteoporosis.
Journal of Bone and Mineral Metabolism 05/1998; 16(2):106-112. · 2.27 Impact Factor
Calcified Tissue International 01/1995; 57(6):409-414. · 2.38 Impact Factor
ABSTRACT: Patients with osteoporosis from 228 medical institutions throughout Japan were randomly divided into 2 groups; Group A (control
group) received no treatment and Group B (the treated group) was given 1α-hydroxy-vitamin D3 1µg daily. Radiography of the thoracic and lumbar spines in the patients were taken before and after one year's study. The two
groups were homogeneous as to age and severity of osteoporosis. The incidence of vertebral fractures was only calculated in
female patients who comprised the major part of each group (named “Group A'” and “B'” respectively).
The incidence of vertebral fractures in 311 female patients in Group A was 759 fractures/1,000 patient·years and in the 355
female patients in Group B was 411/1,000 patient·years. The incidence of fractures increased with advancing age and bone loss
in Group A', but did not in Group B'. From this study, it has been clarified that 1α-hydroxy-vitamin D3 can lower the incidence of vertebral fractures caused by decreasing bone loss.
Journal of Bone and Mineral Metabolism 08/1992; 10(2):50-54. · 2.27 Impact Factor
ABSTRACT: Using a dual photon absorptiometer Dualomex HC-1 based on the scinticamera system utilizing153Gd, bone density of the lumbar vertebrae was measured to set up normative values for each group in both sexes along with fracture
Bone density of the lumbar spine was measured in 712 male and female subjects ranging in age between 16 and 96 years at 11
medical instructions all over Japan, to establish normative values for each age and sex group. The peak bone mass of 0.75
g/cm2 was reached in the 30s in males and that of 0.76 g/cm2 in the 40s in females. The lumbar spine density obtained by this method showed good parallelism with the Singh index and
degree of lumbar spine bone loss according to Jikei University method. A high correlation was also found between the bone
density obtained by this method and that obtained by Lunar DP-4 (r=0.902, n=28). Spinal compression fracture was found in
about 2/3 of the subjects with L2 – L4 bone density measured in the anterior-posterior direction of less than 0.58 g/cm2 and 3/4 of those with the corresponding value less than 0.49 g/cm2. Bone density less than 0.49 g/cm2 was therefore tentatively called the range predicting fracture (dangerous range) and that between 0.49 and 0.58 as the range
warning fracture (warning range).
Journal of Bone and Mineral Metabolism 11/1990; 8(3):30-36. · 2.27 Impact Factor