Effects of one-year cyclical treatment with clodronate on postmenopausal bone loss.

We studied 60 women with postmenopausal bone loss randomly allocated to the following treatments: Group 1 (20 patients), no treatment; Group 2 (20 patients), clodronate 400 mg daily by mouth for 30 consecutive days, followed by 60 days of no treatment; Group 3 (20 patients) oral calcitriol 2 mcg by mouth for 5 days and oral clodronate 400 mg daily for additional 25 days, followed by 60 days of no treatment. The therapeutic cycles were repeated four times in the 12-month study period. In the 36 treated patients of Groups 2 and 3 who completed the study period we observed a progressive and significant increase in lumbar bone density both at 6 and 12 months of therapy, without significant differences between the two treatment protocols (+3.88 +/- 0.65%, P < 0.001 and +3.21 +/- 0.89%, P < 0.005 in Groups 2 and 3, respectively, at the end of the study). In contrast, there was a progressive and significant decline of bone mineral density in untreated patients (-2.34 +/- 0.49%, P < 0.001). After 12 months serum calcium values in treated subjects were higher than in untreated patients (P < 0.05). Serum phosphate was raised only in Group 2, mean values being higher after 12 months than before treatment (P < 0.05); parathyroid hormone (PTH) declined in all treated patients, the fall being significant in Group 2 (P < 0.02). No important side effects were observed with treatment and no patient withdrew because of these. We conclude that cyclical low dose clodronate therapy induced a gain in lumbar spine bone mass in patients with postmenopausal osteoporosis.

A single-blind study of doxazosin in the treatment of mild-to-moderate essential hypertensive patients with concomitant noninsulin-dependent diabetes mellitus.

Doxazosin, a selective alpha 1-inhibitor, was assessed for antihypertensive efficacy, effect on lipid parameters, and safety profile in 21 hypertensive patients with noninsulin-dependent diabetes mellitus. The study involved a 2- to 4-week baseline period, a 10-week period in which patients received doxazosin, 1 to 8 mg, once daily, and a 4-week maintenance period. All 16 of the efficacy evaluable patients (100%) had their blood pressure controlled (sitting diastolic blood pressure less than or equal to 90 mm Hg) at a mean dose of 3.6 mg once daily. For efficacy evaluable patients mean sitting blood pressure was significantly (p less than 0.05) reduced by 26/17 mm Hg at the final visit. Five patients each reported a single side effect and none was severe. No patients required dose reduction or discontinuation of therapy because of side effects. No clinically significant laboratory changes were apparent, and no trends were observed with regard to organ systems or correlations with dose or duration of treatment. The investigators' global assessment of efficacy of once-daily doxazosin therapy was excellent or good for 15 patients and fair for six patients. The overall assessment of patient toleration was excellent or good for 19 patients, fair for one, and not reported for one. High-density lipoprotein cholesterol was significantly increased (p = 0.03). From baseline to final visit, there was a highly significant reduction of 30% (p less than 0.005) in calculated coronary heart disease risk score on the basis of the Framingham equation.