Our hospital began to deliver treatment of the sort which could well fall into line with the newly classified set of good clinical practices in June 1998, and our department began to provide in Norvember 1999. This report provides the results of a survey on the clinical drug trials we have since done. The number of clinical drug trials which had been done at our department before September 2005 and for which the period of registrationhad come to an end was 13. One hundred and sixty-one patients were contracted for clinical drug trials. Of them, consent was secured from 138 patients. The number of registered patients came to 125, and the rate of performance stood at 77.6%. A phase-specific comparison of this rate reveals that Phase II trials in the former period accounted for 25%, Phase II trials in the latter period 90.0%, Phase II/III trials 86.7% and trials for long-term asministration 81.3%. When the performance of clinical drug trials was compared in terms of rate on the basis of whether placebos were involved, the rate was 75.9% for six trials not including placebos and 78.5% for seven trials including placebos. For one trial for an acute disease, the rate was as low as 37.5%. The rate of performance was relatively high at our department, but when it comes to Phase II trials in the former period and trials for acute diseases, the rate of performance was low. The existenceor nonexistence of placebos did not affect the rates of performance.
Clinical ; Performance ; Phase ; Pharmaceutical Preparations ; Acute Disease

Proximal femur fractures (PFFs) are a major cause of disability in the elderly. Some reports say that osteoporosis is a factor contributing to PFFs and values of bonemineral density (BMD) can be used to predict PFFs. In this study we investigated thepossibility of using BMD monitoring to predict the risk of PFFs.
This study compares a PFF group with a nonfracture control group. The selection criteria for both groups were female patients, age 60 and over, on whom dual energy xray absorptiometry (DXA) was performed. The PFF group was composed of 52 patients who were treated between Feb. 1997 and Nov. 1998 and DXA was performed within two weeks postoperatively. The nonfracture control group was made up of 27 patients who were treated for total knee replacement between April 1998 and Dec. 1998 and DXA was performed within two weeks preoperatively.
Histograms were made using BMD data from lumbar and proximal femor measuring sites. The histograms were used to produce receiver-operating characteristic (ROC) curves. After analysing the histograms and ROC curves, two ranges of interest in each DXA report, neck and Wards were selected as the best sites to use when comparing the PFF and control groups.
The two groups were compared to determine cut-off levels for PFFs. For the assessment of fracture risk of the patients with osteoporosis, we would like to propose for neck, 0.600g/cm² BMD in which sensitivity is 76% and specificity is 80%. And for Wards, 0.400g/cm² BMD in which sensitivity is 71% and specificity is 81%.

Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used agents for backache and various joint pains. We suspected that a continuous administration of NSAIDs might suppress bone formation and/or promote bone loss in patients with low bone mineral density (BMD) because the biosynthesis of prostagrandins is inhibited by these drugs. In this study we surveyed the effect of NSAIDs on the bone metabolism in patients with low BMD by comparing a group with NSAIDs administered every day over a period of 1 year and a control group with NSAIDs only occasionally used.
Dual energy x-ray absorptiometry (DXA) was performed on a total of 272 female at our department from April 1999 to September 1999. As a result, 163 cases were found to have BMD less than 80% of the nation's young adult mean values and considered non-secondary in nature. Out of the 163, we chose 14 cases for the NSAID group, and 51 cases for the control group.
The average age, height and body weight were 73.6 years, 149.1cm and 52.1kg for the NSAID group and 71.7 years, 146.7cm and 48.0kg for the control group. There were no statistical differences in all these items. For the treatment of low BMD, 64.9% of the patients in the NSAID group and 52.9% in the control group had anti-osteoporotic medication. In the NSAID group, the relative changes in BMD between the values of the first measurements and those after a 1-year interval were 2.7% decrease at 2nd lumbar vertebra (L2), 12.4% decrease at 3rd lumbar vertebra (L3), 3.9% decrease at 4th lumbar vertebra (L4) and 4.4% decrease at 2nd-4th lumbar vertebra (L2-4). In the control group these were at each site 2.9% increase, 3.6% increase, 2.3% increase and 2.8% increase, respectively. In the NSAID group, BMD changes at neck, Wards, trochanter and shaft of the femur were 3.6% decrease, 4.6% decrease, 4.2% decrease and 3.9% decrease, respectively in the control group, they were 1.0% decrease, 2.2% increase, 1.6% increase and 0.1% increase, respectively. A comparison between the two groups showed thaf the percent changes in BMD of L3, L2-4, Wards, trochanter and shaft of the femur were statistically significant in the NSAID groups.
The present data suggest that the regular use of NSAIDs enhances bone loss in patients with low bone density detected by DXA examination.

This study was conducted to find out whether or not sports contribute to an increase in bone mineral density (BMD) and the prevention of fractures in postmenopausal women. A total of 361 women with low levels of BMD and no evidence of any associated illness were enrolled in this study. They were divided into three groups: group A consisting of 30 women (including 11 farmers) who play sports regularly at the present; group B consisting of 111 women (including 41 farmers) who were in for sports in their youth; and group C consisting of 220 women (including 89 farmers) who have never participated in regular sports.
There were no significant differences among these three groups in BMD of the lumbar vertebrae. In the proximal femur, group C showed significantly lower BMD values than the other two groups and in each group farmers had significantly lower values than non-farmers.
The incidence of vertebral fractures was 30.0% in group A (36.4% in farmers), 36.3% in group B (29.3% in farmers) and 47.7% in group C (52.8% in farmers).
These results indicated that practicing sports on a regular basis is beneficial to postmenopausal women as it is effective in maintaining a level of BMD and preventing compression fractures.

We studied the outcome of the surgical treatments, mainly on the walking ability, of the 113 femoral neck fractures of 113 limbs in the elderly, 70 and over, who were admitted in our hospital during the period between Nov. 1992 and Nov. 1996.
Sixty-six of the 113 cases (60.0%) regained the pre-traumatic walking abilities. The rest of the cases, particularly patients over age 85, failed to make good recoveries because of advanced age aging, presence of various complications, types of fractures, and/or poor pre-traumatic walking abilities.
Among various types of complications, dementia appeared as the number one factor in the poor recuperation. We, therefore, recommend that speech therapy as well as occupational therapy be used in the elderly with dementia to arrest further deterioration, and those without to prevent the occurrence of dementia during the perioperative periods with particular emphasis on the preoperative period while patients are still in bed with their legs under traction.
The cases with inside neck fractures of Garden classification type III/IV recovered excellently, for which we applied bipolar arthroplasty (bipolar prosthesis with femoral stem). This is because the bipolar arthroplasty technique ensured much firmer fixation at the fracture site, earlier rising from bed, and earlier weight bearing than in the case of other operative techniques.
The cases with the unstable lateral type of fractures, that are to be cured in osteosynthesis, and so treated by the Ender technique, did not recover well, because of infirm fixation at the fracture site, late rising and bearing times, and eventual concurrence and/or worsening of dementia.
We, therefore, inclined to think that bipolar arthroplasty surgery would be more appropriate for the case of an unstable, complex type of fracture than the Ender fixation maneuver would be, because the former ensures the better outcome.

In our department, we use Jinnaka's Rehabilitation method as a means of aftertreatment of patients who underwent surgery to repair fresh Achilles tendon ruptures. In this paper, we compared the results of tendon ruptures in farmers with those in other occupational workers, who visited our hospital for surgical treatment from April 1990 to December 1996. The data required in this study were collected by interviewing each patient by telephone.
We repaired 22 tendons in farmers, another 22 tendons in manual, laborers, and 36 tendons in non-manual laborers (office workers, 32 tendons and housewives, 4 tendons.) The average period of follow-up was 4 years and 3 months. Re-rupture was observed in only one of the non-manual laborers. The average age of the farmer group was 50.4 years, which was higher than those of the other two groups-43.0 years for the manual laborer group, and 38.4 years for the non-manual laborer group. 83.3% of the patients in the non-mnual laborer group could return to engaging in sports. However, a smaller number of patients, 50.4%, look part in sports in either the farmer group or the manual laborer group respectively.
This low rate of comeback to sports in the farmer group may reflect their belief that physical exercise is unnecessary in light of the farmer's life style.
There are some reports that claim that farmers should engage in some kinds of sport, repeatedly and at regular intervals, to promote and maintain their health, because physical activity in farming is not necessarily sufficient or appropriate from the view point of health preservation.
It is good to promote the idea that farmers, who perform physical labor, should also take part in some kind of sport.