Vitamin D insufficiency: evaluation of an oral standardized supplementation using 100,000 IU vials of cholecalciferol, depending on initial serum level of 25OH vitamin D.

OBJECTIVES: There is no protocol of vitamin D supplementation used worldwide due to a great disparity of vitamin D supplements available in different countries. The aim of this study was to evaluate the efficiency of the protocol most often used in France to correct vitamin D deficiency defined by a serum 25-hydroxy vitamin D (25OHD) level of less than 30 ng/mL. METHODS: This was a pragmatic multicentric study of vitamin D supplementation in 257 osteopenic/osteoporotic, vitamin D deficient patients who received 100,000 UI vitamin D3 vials every two weeks according to their initial serum 25OHD level (four vials when 25OHD less than 10 ng/mL, three when 25OHD was 10-19 ng/mL, two when 25OHD was 20-29 ng/mL). Blood samples were obtained at baseline, one (M1), two (M2), and three months (M3), after the end of the supplementation protocol. RESULTS: At M1, 198/257 (77%) patients had a serum 25OHD level more than 30 ng/mL. Eighty-five percent of those with a BMI less than 25 kg/m2 had a 25OHD concentration more than 30 ng/mL, whereas only 66% of those with a BMI more than 25 had a level more than 30 ng/mL. At M2 and M3, 25OHD levels decreased significantly with 55% and 46% having still a level more than 30 ng/mL respectively, without any significant difference according to the initial 25OHD level. CONCLUSION: This protocol was effective in rising serum 25OHD of most vitamin D insufficient patients with a BMI less than 25 kg/m2, but not in overweight patients. As almost one half of our patients had a serum 25OHD level less than 30 ng/mL at M2, we suggest that regular doses should be started quite soon after this initial supplementation.

Monitoring of bone turnover markers does not improve persistence with ibandronate treatment.

OBJECTIVE: To assess if the use of biological marker of bone resorption (CTX) feedback is a mean to improve persistence on monthly oral ibandronate. METHODS: One year prospective multicenter study using a cluster randomisation design with physicians as randomized units into two groups, A and B; in group B, physicians used results of CTX and two standardized messages according to CTX changes from baseline: suboptimal if decrease less than 30% at week 6, positive otherwise. In group A, the follow-up was standard of care. Patients were postmenopausal women, initiating a treatment with ibandronate 150 mg monthly. They were blinded to the study hypotheses and outcome. The outcome was the proportion of patients persistent at 1-year visit. RESULTS: Eighty-eight physicians were randomized in group A and included 346 patients, 75 in group B included 250 patients. The persistence at 1-year was high and not different between the two groups (75.1 and 74.8% P=0.932). There was no difference in the proportion of persistent patients according to the message delivered in the group of patient with CTX information: 77.4 and 74.8% in patients with a suboptimal or positive message respectively. CONCLUSION: This study failed to demonstrate that supporting monitoring of CTX could improve persistence to ibandronate treatment in postmenopausal osteoporosis. KEY MESSAGES: Persistence is a strong determinant of anti-osteoporotic treatments efficacy. Monitoring of bone markers is not a mean to improve persistence of an oral bisphosphonate. There is a discrepancy between levels of persistence in clinical studies and real life.

A pilot study on the recovery from paresis after lumbar disc herniation.

BACKGROUND: Although the existence of a motor defect in discogenic sciatica is a sign of severity, the literature does not provide evidence for an immediate requirement for surgery. OBJECTIVE: To assess the course of sciatica with discogenic paresis and to determine possible prognostic factors for recovery or improvement. STUDY DESIGN: This open prospective multicenter study included patients with discogenic sciatica with paresis that had been developing for less than 1 month and was rated < or =3 on a 5-grade scale. Pain, the strength of 11 muscles, return to work, and analgesic intake were assessed at 1, 3, and 6 months. Recovery and improvement were defined by pain not exceeding 20 mm or < or =50% of the initial pain score and a score of either 5 (recovery) or 4 (improvement) for the weakest muscle at inclusion. RESULTS: Sixty-seven patients were enrolled; 39 (58%) patients were treated surgically and 28 (42%) medically. Surgically treated patients differed from medically treated patients by a higher rate of extruded herniation, a higher number of paretic muscles (6.3 vs. 5; P = 0.051), and a longer course of sciatica (31.4 vs. 17.3 days; P = 0.034). At 6 months, 7 (10.4%) patients were lost to follow-up; 32 (53.3%) had improved, including 18 (30%) recovered, 33 (85%) back to work and having a professional activity, and 22 (39%) still taking analgesics. The only significant difference between recovered and not recovered patients was mean age at inclusion (43 vs. 51 years, P = 0.034). There were no significant differences between improved and not improved patients. Moreover, the outcome was not different in the two treatment groups: there were 17 (53%) improvements in surgically treated patients, including 8 (25%) recoveries, and 14 (56%) improvements in medically treated patients, including 8 (40%) recoveries. CONCLUSION: This pilot study showed no difference between surgical or medical management for recovery or improvement in patients with discogenic paresis. These results need confirmation by a randomized study.