Development and assessment of the Osteoporosis Index of Risk (OSIRIS) to facilitate selection of women for bone densitometry.

A simple questionnaire would be useful to identify individuals most in need of bone mineral density (BMD) testing. We designed a new predictive model and risk assessment instrument based on an extensive review of the literature evaluating risk factors for osteoporosis, and tested its performance in a large cohort of postmenopausal women in whom BMD was measured by dual x-ray absorptiometry. In total, 1303 postmenopausal women from an outpatient osteoporosis clinic participated in this study. The Osteoporosis Index of Risk (OSIRIS) is based on four variables: age, body weight, current hormone replacement therapy use and history of previous low impact fracture. The sensitivity and specificity for an OSIRIS value of +1 were respectively 78.5% and 51.4%. The AUC under the ROC curve of OSIRIS was 0.71. Three categories were arbitrarily created using OSIRIS, with cutoff of +1 and -3. The low risk category (OSIRIS > +1) represented 41% of all women; only 7% of the women in this category had osteoporosis. The prevalence of osteoporosis was very high (66%) among the group at high risk (OSIRIS < -3 representing 15% of all women). The prevalence of osteoporosis was 39% in the intermediate risk group (-3 < OSIRIS < +1, 44% of all women). In conclusion, OSIRIS is a simple index based on four easy-to-collect variables from postmenopausal women, it shows a high degree of accuracy, and performed well for classifying the degree of risk of osteoporosis in western European women of Caucasian lineage. Based on this instrument it is possible to propose a strategy that would initiate treatment in women with very high risk, postpone BMD measurement in women with low risk and limit BMD measurement to women with intermediate risk of osteoporosis, this would spare more than 55% of the densitometry bill compared with a mass screening scenario.

[Evaluation of the efficacity and speed of action of sertaconazole nitrate suppository and cream combined treatment for vulvovaginal candidiasis]. / Evaluation de l'efficacité et de la rapidité d'action d'un traitement associant un ovule et une crème de nitrate de sertaconazole dans la candidose vulvovaginale.

OBJECTIVE: To assess efficacy and speed of action of a monodose sertaconazole vaginal suppository administered as a single treatment or combined with sertaconazole cream applied to the vulvar area. METHODS: This prospective, multicentric, randomised open study was conducted on 77 women with vulvovaginal candidiasis confirmed by mycological examination. They were either treated with one sertaconazole monodose vaginal suppository only (group O) or treated with the suppository combined with sertaconazole cream applied to the vulvar area for 7 days (group OC). The patients who were not clinically cured at D7 received a second phase of treatment. RESULTS: Clinical cure rates were higher in group OC than in group O at D7 (76% versus 68%), and D14 (100% versus 80%). The efficacy on symptoms was faster in group OC, with 78% of the patients relieved of pruritus as early as D2 versus 61% in group O, although these differences were not significant. Clinical local tolerance was very good, with 95% of patients not experiencing any local side effects. CONCLUSION: When candidiasis is both vulvar and vaginal, the combination of sertaconazole cream with a monodose sertaconazole vaginal suppository tends to improve clinical cure at D7 and D14 and to relieve more patients as early as D2 than the vaginal suppository used as a single treatment.

[Comparative study of the acceptability of a new estradiol Tx 11323 (A) gel and a transdermal matrix system]. / Etude comparative de l'acceptabilité d'un nouveau gel d'estradiol TX 11323 (A) et d'un dispositif transdermique matriciel.

OBJECTIVE: to compare the acceptability of a new estradiol gel TX 11323 (A) and a transdermal matrix system. METHOD: this randomised open crossed study was conducted on 80 healthy menopausal female volunteers treated successively with 1.5 mg of estradiol per day in gel form (Estreva Gel, Theramex, Monaco) and by a transdermal matrix twice-weekly system delivering 50 micrograms/24 h of estradiol (Oesclim 50, Fournier, Dijon-France). The treatment was applied for 25 days with an interval of 6 days between the 2 administration cycles. Acceptability was evaluated and compared by a self-questionnaire given on D1 and D25 of each therapeutic cycle. RESULTS: the 2 treatments, after 25 days of use, were judged convenient, easy and fast to use by more than 90% of subjects. There was, nevertheless, a significant difference in favour of the gel in respect of the estimation of the "visual aspect" of the treatment, reported skin problems, problems with application technique, as well as discomfort during intimacy found in 11% of cases using the transdermal system. It is noted that 80% of the women consider the gel treatment more feminine (p < 0.001) and that 61.3% prefer this treatment compared to 32.5% preferring the transdermal system studied (p = 0.005). CONCLUSION: this study shows a better acceptability of the estradiol gel TX 11323 (A) compared to that of the transdermal matrix system studied.

[Comparative study of the short-term acceptability and tolerance of a new oral formulation of magnesium (TX 1341) and a reference magnesium]. / Etude comparative de l'acceptabilité et de la tolérance à court terme d'une nouvelle formulation orale de magnésium (TX 1341) et d'un magnésium de référence.

This open, randomized study on 2 parallel groups compared the acceptability, digestive tolerance and observance of TX 1341, a new chewable magnesium tablet (OROMAG, Laboratoire Théramex) to that of a reference magnesium (MAG2, Laboratoire Théraplix). 179 patients warranting a magnesotherapy were treated for 10 weeks either by 3 chewable lactate and citrate of magnesium tablets (TX 1341) each containing 120 mg of magnesium-element, or by 3 drinkable ampoules of pidolate of magnesium (each of 122 mg of magnesium-element). Acceptability was assessed at the end of the study by a semi-quantitative scale at four levels and digestive tolerance by closed questionnaire submitted before and after treatment. 72.7% of patients treated by TX 1341 find the treatment agreeable against 46.1% with the reference magnesium (p < 0.01). The number of drops out linked to treatment is not significantly different in the two groups and they are virtually all linked to digestive problems. The two medications significantly lower the number of cases of constipation without noticeably increasing the number of cases of diarrhea. The comparison of the number of digestive symptoms which appeared under treatment only underline one significant difference between the 2 groups (p < 0.05): the appearance of 5 times less the number of abdominal pains with TX 1341 (2 cases). Cases of irregular intake are significantly higher with the reference drug than with TX 1341 (respectively 23.7% and 8.5%; p < 0.01).

[Validation of a questionnaire for the evaluation of the quality of life in menopause]. / Réduction d'un questionnaire d'évaluation de la qualité de vie en ménopause.

A 15 item-questionnaire designed and weighted by experts has been validated in terms of acceptability, validity, reproducibility and responsiveness. This French original tool allows a precise clinical evaluation of quality of life in menopausal women and of its changes with hormonal therapy.

[Comparative evaluation of the acceptability of a new estradiol gel TX11323(A) and a reference gel]. / Evaluation comparative de l'acceptabilité du nouveau gel d'estradiol TX11323(A) et d'un gel de référence.

This randomized, crossed, single-blind study compared the acceptability and drying time of the new estradiol gel TX11323(A) (Estréva Gel, Laboratoire Théramex) to that of a reference gel (CEstrodose, Laboratories Besins-Iscovesco), in two phases. In phase 1, 48 healthy menopausal female volunteers applied 1.5 mg estradiol of each form of estradiol gel on the outer side of the arm for 8 days, with a free period of 7 days between the two treatments. Acceptability, evaluated by self-questionnaire and drying time for the two treatments were noted at day 1 and day 8. The second phase applied only to 16 subjects who followed the same therapeutic protocol, except that this time application was made on the antero-external side of the thighs. Only the subjectively and objectively quantified drying-time was taken into account. A significant difference was found in favor of TX11323(A) gel in terms of the following items: consistency, ease of application and penetration, quantity of gel to apply, sensation of lasting stickness. We note that 68.8% subjects prefer TX11323(A) gel and 27.1% prefer the reference gel (p = 0.001). The timed drying-time for TX11323(A) gel is significantly reduced, 40 to 50% on average depending on the phase, compared to that of the reference gel. The subjective evaluation of the subjects confirms this shorter drying time.