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Double-dummy Study (double-dummy + study)
Selected AbstractsEffects of denosumab on bone mineral density and bone turnover in postmenopausal women transitioning from alendronate therapyJOURNAL OF BONE AND MINERAL RESEARCH, Issue 1 2010David L Kendler Abstract Patients treated with bisphosphonates for osteoporosis may discontinue or require a switch to other therapies. Denosumab binds to RANKL and is a potent inhibitor of bone resorption that has been shown to increase bone mineral density (BMD) and decrease fracture risk in postmenopausal women with osteoporosis. This was a multicenter, international, randomized, double-blind, double-dummy study in 504 postmenopausal women,,,55 years of age with a BMD T- score of ,2.0 or less and ,4.0 or more who had been receiving alendronate therapy for at least 6 months. Subjects received open-label branded alendronate 70,mg once weekly for 1 month and then were randomly assigned to either continued weekly alendronate therapy or subcutaneous denosumab 60,mg every 6 months and were followed for 12 months. Changes in BMD and biochemical markers of bone turnover were evaluated. In subjects transitioning to denosumab, total hip BMD increased by 1.90% at month 12 compared with a 1.05% increase in subjects continuing on alendronate (p,<,.0001). Significantly greater BMD gains with denosumab compared with alendronate also were achieved at 12 months at the lumbar spine, femoral neck, and 1/3 radius (all p,<,.0125). Median serum CTX levels remained near baseline in the alendronate group and were significantly decreased versus alendronate (p,<,.0001) at all time points with denosumab. Adverse events and serious adverse events were balanced between groups. No clinical hypocalcemic adverse events were reported. Transition to denosumab produced greater increases in BMD at all measured skeletal sites and a greater reduction in bone turnover than did continued alendronate with a similar safety profile in both groups. Copyright © 2010 American Society for Bone and Mineral Research [source] Wound infiltration with magnesium sulphate and ropivacaine mixture reduces postoperative tramadol requirements after radical prostatectomyACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 4 2009P. TAUZIN-FIN Purpose: This prospective, randomized, double-dummy study was undertaken to compare the effects of magnesium sulphate (MgSO4) administered by the intravenous vs. the infiltration route on postoperative pain and analgesic requirements. Methods: Forty ASA I or II men scheduled for radical retropubic prostatectomy under general anaesthesia were randomized into two groups (n=20 each). Two medication sets A and B were prepared at the pharmacy. Each set contained a minibag of 50 ml solution for IV infusion and a syringe of 45 ml for wound infiltration. Group MgSO4.IV patients received set A with 50 mg/kg MgSO4 in the minibag and 190 mg of ropivacaine in the syringe. Group MgSO4/L received set B with isotonic saline in the minibag and 190 mg of ropivacaine +750 mg of MgSO4 in the syringe. The IV infusion was performed over 30 min at induction of anaesthesia and the surgical wound infiltration was performed during closure. Pain was assessed every 4 h, using a 100-point visual analogue scale (VAS). Postoperative analgesia was standardized using IV paracetamol (1 g/6 h) and tramadol was administered via a patient-controlled analgesia system. The follow-up period was 24 h. Results: The total cumulative tramadol consumption was 221 ± 64.1 mg in group MgSO4.IV and 134 ± 74.9 mg in group MgSO4.L (P<0.01). VAS pain scores were equivalent in the two groups throughout the study. No side-effects, due to systemic or local MgSO4 administration, were observed. Conclusion: Co-administration of MgSO4 with ropivacaine for postoperative infiltration analgesia after radical retropubic prostatectomy produces a significant reduction in tramadol requirements. [source] Efficacy of oral rofecoxib versus intravenous ketoprofen as an adjuvant to PCA morphine after urologic surgeryACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 9 2004M. C. Cabrera Background:, Adjunctive use of nonsteroidal anti-inflammatory drugs has become increasingly popular in the perioperative period because of their opioid-sparing effects. This randomized, controlled, double-dummy study was designed to evaluate the cost-effectiveness of using oral rofecoxib as an alternative to intravenous ketoprofen for pain management in patients undergoing urologic surgery. Methods:, Seventy patients were randomly assigned to receive either a placebo (Control) or rofecoxib 50 mg po (Rofecoxib) 1 h prior to surgery. After a standardized spinal anesthetic, patients in the Control group received ketoprofen 100 mg IV q 8 h for 24 h, while the Rofecoxib group received an equivolume of saline at 8-h intervals for 24 h. Both groups were allowed to self-administer morphine (1 mg IV boluses) using a PCA delivery system. The need for ,rescue' analgesic medication, as well as pain scores [using an 11-point verbal rating scale (VRS) (0 = none to 10-severe)], were recorded at 1, 2, 6, 12, and 24-h intervals after surgery. In addition, the incidences of side-effects were recorded at the end of the study period. Results:, Total amount of morphine required in the initial 24-h postoperative period was nonsignificantly reduced in the Rofecoxib group (29 ± 2 vs. 37 ± 4 mg). More importantly, the percentage of patients reporting moderate-to-severe pain (VRS score ,4) during the study period was lower in the Rofecoxib group (12 vs. 22%, P < 0.05). The daily cost of rofecoxib (USD 1.14 for 50-mg dose) was also significantly less than ketoprofen (USD 3.06 for three 100-mg doses). Conclusion:, Premedication with oral rofecoxib (50 mg) is a cost-effective alternative to the parenteral nonselective NSAID, ketoprofen (100 mg q 8 h), when used as an adjuvant to PCA morphine for pain management after urologic surgery. [source] Clinical efficacy of sublingual and subcutaneous birch pollen allergen-specific immunotherapy: a randomized, placebo-controlled, double-blind, double-dummy studyALLERGY, Issue 1 2004M. S. Khinchi Background:, Both sublingual allergen-specific immunotherapy (SLIT) and subcutaneous immunotherapy (SCIT) have a documented clinical efficacy, but only few comparative studies have been performed. Objective:, To investigate the clinical efficacy of SLIT vs SCIT and secondary to compare SLIT and SCIT with placebo and to evaluate the relative clinical efficacy in relation to systemic side-effects. Methods:, A 3-year randomized, placebo-controlled, double-blind, double-dummy study including 71 adult birch pollen hay fever patients treated for two consecutive years after a baseline year. Allocation to treatment groups was based on disease severity in the baseline season, gender and age. Results:, Clinical efficacy was estimated in 58 patients completing the first treatment year by subtracting baseline data and by calculating the ratio first treatment season vs baseline. SLIT diminished the median disease severity to one-half and SCIT to one-third of placebo treatment. No statistical significant difference between the two groups was observed. Both for symptoms and medication scores actively treated patients showed statistically significant and clinical relevant efficacy compared with placebo. SLIT treatment only resulted in local mild side-effects, while SCIT resulted in few serious systemic side-effects. Conclusion:, Based on the limited number of patients the clinical efficacy of SLIT was not statistically different from SCIT, and both treatments are clinically effective compared with placebo in the treatment of birch pollen rhinoconjunctivitis. The lack of significant difference between the two treatments does not indicate equivalent efficacy, but to detect minor differences necessitates investigation of larger groups. Due to the advantageous safety profile SLIT may be favored. [source] | ||||||||||