Anti-fracture efficacy of zoledronate in subgroups of osteopenic postmenopausal women: secondary analysis of a randomized controlled trial.

BACKGROUND: We recently reported that the administration of zoledronate every 18 months to osteopenic older women reduces the incidence of fractures. OBJECTIVE: Here, we present a more detailed analysis of that trial to determine whether baseline clinical characteristics impact on the anti-fracture efficacy of this intervention. METHODS: This is a prospective, randomized, placebo-controlled, double-blind trial in osteopenic postmenopausal women aged ≥ 65 years, to determine the anti-fracture efficacy of zoledronate. 2000 women were recruited using electoral rolls and randomized to receive 4 infusions of either zoledronate 5 mg or normal saline, at 18-month intervals. Each participant was followed for 6 years. Calcium supplements were not supplied. RESULTS: Fragility fractures (either vertebral or nonvertebral) occurred in 190 women in the placebo group (227 fractures) and in 122 women in the zoledronate group (131 fractures), odds ratio (OR) 0.59 (95%CI 0.46, 0.76; P < 0.0001). There were no significant interactions between baseline variables (age, anthropometry, BMI, dietary calcium intake, baseline fracture status, recent falls history, bone mineral density, calculated fracture risk) and the treatment effect. In particular, the reduction in fractures appeared to be independent of baseline fracture risk, and numbers needed to treat (NNT) to prevent one woman fracturing were not significantly different across baseline fracture risk tertiles. CONCLUSIONS: The present analyses indicate that the decrease in fracture numbers is broadly consistent across this cohort. The lack of relationship between NNTs and baseline fracture risk calls into question the need for BMD measurement and precise fracture risk assessment before initiating treatment in older postmenopausal women.

No evidence of enhanced satiety following whey protein- or sucrose-enriched water beverages: a dose response trial in overweight women.

BACKGROUND/OBJECTIVES: To compare the effect of low-dose whey protein-enriched and sucrose-enriched water beverages on postprandial satiety and energy intake. SUBJECTS/METHODS: Sixty overweight and obese women were given water-based protein and carbohydrate (CHO) beverages or placebo on six different occasions in a double-blind, randomised cross-over study. The beverages were 2 (178 kJ) and 4% (348 kJ) protein-enriched water (Clear Protein8855), 2 (157 kJ), 4 (314 kJ) and 10% (785 kJ) sucrose-enriched water, and a sweetened water control. Beverages were matched for volume, colour, flavour and sweetness. A standardised evening meal was provided before each study day and a standardised breakfast upon arrival at the clinic at 0900 hours. The beverage preload was given midmorning at 1100 hours, and an ad libitum outcome lunch meal at 1300 hours. Subjective appetitive responses were recorded through the day until 1500 hours using visual analogue scales. RESULTS: Fifty-five participants completed all six beverage conditions. Neither protein nor sucrose preloads decreased any of hunger, fullness, thoughts of food or satisfaction when compared with the sweetened water control beverage (all, P>0.05). There was also no significant effect on ad libitum energy or macronutrient intake at the outcome meal (P>0.05), with no compensation for the energy consumed within the preload beverages. CONCLUSIONS: There was no evidence of increased postprandial satiety or compensation for energy content at an outcome lunch meal when a water beverage was supplemented with up to 4% (w/w) whey protein or 10% (w/w) sucrose, in a group of overweight but unrestrained young and middle-aged women.