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Hand and feet x-rays were obtained before administration of study agent at weeks 0 and 24 or upon premature discontinuation.
Venous blood was collected at enrollment immediately before administration of study drug (0 h) and at 12, 24, 48, and 72 h thereafter.
Blood samples for serum concentration measurement will be taken 3 hours after the patient has taken the study drug (each time) on day 1 and just before administration of study drug between 0800 and 0900 on day 2. The serum concentration levels and pharmacodynamic responses will be assessed by an independent Data Monitoring Committee.
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These analyses were done using fasting samples collected before administration of the study medication (i.e. at trough lanreotide levels).
Anticholinergic agents were allowed from 2 hours before administration of the study drug to the end of the study only when the treatment was continuously used and could not be stopped or it was used as a new treatment for adverse events.
Subjects were hospitalized from 2 days before administration of the study drug to 1 day after administration of the study drug in each treatment period.
These patients were enrolled as part of a longitudinal study investigating the effects of zoledronic acid on the progression of bone erosions in PsA (the zoledronic acid in psoriatic arthritis or ZAPA study), but results presented here pertain only to baseline findings in these patients, before administration of the study drug or placebo.
The samples were taken before administration of the study drug.
15 Blood samples were drawn before administration of the study agent.
Baseline levels of total PSA measured before administration of the study drugs ranged from 15 to 2,400 ng/ml.
A total of 316 patients were randomised; eight withdrew consent before administration of any study agents (figure 1).
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