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PURPOSE: To determine the efficacy and safety of cyclical etidronate for up to 7 years in the treatment of postmenopausal osteoporosis and to examine the effects of discontinuing treatment after 2 or 5 years of therapy. PATIENTS AND METHODS: Patients were randomized at entry into the original study in 1986 to blinded treatment for 2 years with either a calcium (placebo) or an intermittent cyclical etidronate regimen, which most patients continued for a third year. Following this phase of the study, patients were enrolled into an open-label, follow-up study (years 4 and 5), during which all patients received cyclical etidronate treatment. In the present double-blind study (years 6 and 7), patients were rerandomized to receive intermittent cyclical therapy with either etidronate or placebo; all patients received calcium. The treatment regimen consisted of 400 mg/day etidronate or placebo for 14 days, followed by 76 days of elemental calcium (500 mg/day); this cycle was repeated approximately 4 times in each year. Of the 193 patients who continued in years 6 and 7 of the study, 93 were randomized to receive cyclical etidronate and 100 were randomized to receive calcium only. For purposes of efficacy analyses, patients were categorized by their total years of cumulative etidronate treatment (7, 5, 4, or 2 years). There were 51, 46, 42, and 54 patients in the 7-, 5-, 4-, and 2-year groups, respectively. Annual assessments included lumbar spine bone mineral density (BMD), as measured by densitometry, and vertebral radiographs. RESULTS: The groups receiving cyclical etidronate during this 2-year study period (7-and 4-year groups) had statistically significant mean percent increases in spinal BMD of 1.8% and 2.2%, respectively (P [is less than] 0.05) at the week 104 observation time. The 5- and 2-year groups, which did not receive etidronate during this period, had mean values of 1.4% and 0.2%, respectively (not significant) at week 104. in the 7-, 5-, 4-, and 2-year groups, the increases in spinal BMD at the end of 7 years were 7.6%, 8.6%, 8.1%, and 3.9%, respectively; these values were statistically significant for all groups compared with original baseline (year 0) (P [is less than] 0.05). BMD of the femur and wrist was maintained throughout the 7-year period. The incidence and rate of vertebral fractures were lowest in patients with the longest exposure to etidronate. Etidronate was well tolerated during the study, with low incidences of gastrointestinal side effects and nonvertebral fractures. CONCLUSIONS: Long-term cyclical etidronate is a safe, effective, and well-tolerated treatment for postmenopausal osteoporosis. Bone mass is maintained for at least 2 years after treatment with etidronate is stopped; however, further gains in spinal bone mass are seen in patients who continue therapy.

PURPOSE: To describe the clinical, histologic, and radiologic findings in patients with diabetic muscular infarction (DMI). MATERIALS AND METHODS:Descriptive case series of 3 patients with DMI and 22 previously reported cases (MEDLINE data base search) in the English literature are presented. RESULTS: Diabetic muscular infarction is usually seen in patients with long-standing insulin-dependent diabetes and multiple end-organ microvascular complications. Two-thirds of patients with DMI are women, with a mean age at presentation of 39 [+ or -] 12 years. The typical clinical presentation includes abrupt onset of thigh pain and tenderness. There is a palpable, painful mass, with swelling and induration of the surrounding tissue without systemic symptoms or signs. The painful lesion persists for weeks, occasionally with exacerbations of symptoms, then spontaneously resolves over several weeks to months. Recurrent episodes are reported in half of the patients. Muscles commonly affected are the vastus lateralis, thigh adductors, and biceps femoris; but calf muscles may be involved as well. Active pathologic changes in the muscle are more sensitively evaluated with T2-weighted sequences on magnetic resonance (MR) imaging, which shows high intensity in involved muscle. Histologic features of DMI consist of large areas of muscle necrosis and edema. Regenerating muscle fibers and lymphocytic interstitial infiltration may be present. CONCLUSION: Diabetic muscular infarction is a rare complication of diabetes mellitus. in most patients, the diagnosis can be made when the characteristic clinical presentation is combined with a typical MR imaging results. Muscle biopsy can be helpful in establishing the diagnosis of DMI, but histologic findings are not specific. Awareness of this syndrome plus MR imaging as the first diagnostic test should lead to the correct diagnosis and shorter hospitalization. Am J Med. 1996; 101:245-250.

PURPOSE: To determine the effect of long-term intermittent cyclic etidronate treatment on spinal bone density and vertebral fracture rates. PATIENTS AND METHODS: Postmenopausal osteoporotic women (n = 423) were randomized initially into a 2-year, double-blind, multicenter study, it was extended to a third year of blinded treatment followed by open-label treatment: 357 patients continued treatment in Year 3 (305 receiving blinded therapy and 52 receiving calcium supplementation) and 277 in Year 4. During Years 1 through 3, patients received double-blind treatment with phosphate (1.0 g) or placebo twice daily for 3 days, etidronate (400 mg) or placebo daily for 14 days, and calcium (500 mg) daily for the remainder of each 91-day treatment cycle. During Year 4, open-label intermittent cyclic etidronate therapy (without preceding phosphate) was administered to all patients. Spinal bone density and vertebral fracture rates were the main outcome measures. RESULTS: During Year 3, etidronate therapy maintained the significant increases in spinal bone mineral density of the first 2 years. Over the 3-year period, proximal femur bone density increased in etidronate-treated patients. Etidronate therapy for 3 years significantly decreased the vertebral fracture rate in patients at higher risk for fracture (low spinal bone density and three or more vertebral fractures at study entry), as compared with nonetidronate treatment (228 versus 412 fractures per 1,000 patient-years, respectively, p

Weight loss is an important aspect of therapy for obese patients with non-insulin-dependent diabetes mellitus (NIDDM). However, blood glucose levels do not always improve after weight loss. Factors that might predict the ability of diet therapy to improve blood glucose levels were assessed in 135 obese patients with NIDDM, who lost at least 9.1 kilograms (kg; 20.0 pounds or lbs.) of body weight. After losing weight, the patients' blood glucose levels were tested and they were subdivided into two groups. Measurements revealed that blood glucose was an average of 7 millimoles per liter in 55 of 135 patients, who were classified as responders; their blood glucose levels had begun to improve after only a slight loss of weight. Eighty of 135 patients were nonresponders; their blood glucose levels measured an average of 18.3 millimoles per liter following weight loss. Improvement in blood glucose levels after weight loss was best predicted by a blood glucose level of 10 millimoles per liter or less after a 2.3 kg (5.0 lbs) and 4.5 kg (9.9 lbs) weight loss. Many patients with NIDDM do not have improved blood glucose levels after weight loss. The effectiveness of diet therapy can be predicted on the basis of blood glucose levels after a 2.3 (5.0 lbs) and 4.5 kg (9.9 lbs) weight loss. It is recommended that patients with NIDDM who remain hyperglycemic (have high blood glucose levels) after losing weight, be considered for treatment with insulin or oral hypoglycemic agents, which lower blood glucose levels. (Consumer Summary produced by Reliance Medical Information, Inc.)

Many aspects of osteoporosis (a condition in which bone mass is gradually reduced), such as diagnosis and evaluation, causes, prevention, and treatment are now at least partially understood. Therefore, primary care physicians need to be aware of the risk factors associated with this disorder. A study in the March 1991 issue of The Journal of Family Practice indicated that risk factors are rarely documented or are documented incompletely; the risk-factor approach, however, may overly complicate the situation. Two terms are described: osteoporosis, a condition of bone mass loss associated with fractures in the absence of trauma; and osteopenia, a condition of low bone mass where no fractures have occurred. Osteopenia is thus the major risk factor for osteoporosis, but accurate prediction of which patients will develop fractures is impossible. The risk factors for osteopenia include the nonremediable ones of ethnicity, advanced age, family history, small frame, and low body weight. Some factors are remediable: cigarette smoking, heavy use of alcohol, a sedentary lifestyle, and the use of certain medications (glucocorticoids, anticonvulsants, thyroid hormones). When decisions concerning estrogen administration (the only currently approved method for preventing osteoporosis) are made, broader issues concerning patients' health should be considered. The drawbacks of estrogen therapy, (endometrial cancer, blood clots, aggravation of fibrocystic breast disease) need to be considered. Patients should be informed regarding the optimal calcium intake. The best approach to evaluating the extent of osteopenia is measurement of bone density, and it may be wise to perform such measurements in all women around the age of menopause. Clinical evaluation does not accurately identify at-risk patients. Techniques of bone density measurement are described. Salmon calcitonin is the only drug now approved for treating established osteoporosis; other agents under consideration are discussed. The condition can only be effectively prevented by using bone densitometry to identify women with osteopenia; many patients cannot be diagnosed by clinical criteria alone. (Consumer Summary produced by Reliance Medical Information, Inc.), Prevention of Osteoporosis: The Role of Primary Physicians There has been a rapid escalation of knowledge about osteoporosis over the past several years. We now have a clear understanding of [...]