Objectives: An open study was carried out to evaluate changes in bone remodeling markers such as N-telopeptide (NTx), tartrate-resistant acid phosphatase (TRAP), total alkaline phosphatase (TAP), and bone alkaline phosphatase (BAP) during a 1-year continuous tibolone treatment in postmenopausal women. Material and methods: Thirty-six postmenopausal women were recruited for receiving tibolone 2.5 mg per day for 1 year. Densitometry and determination of biochemical markers of bone metabolism in serum and urine were performed at 1, 3, 6, and 12 months. Results: Comparing baseline with 12 month's values, BAP and all resorption markers decreased significantly. NTx began to decrease since the initiation of the treatment (baseline: 74.4±5.3; 1 month: 57.5±4.2; 12 months: 36.6±2.8). BAP increased at the first month (baseline: 37.3±2.1; 1 month: 42.6±3.0) but diminished in the following months (12 months: 23.1±1.5). TAP started to decrease significantly only after 6 months of treatment (baseline: 37.3±2.1; 12 months: 31.4±2.3) and TRAP after 3 months (baseline: 9.8±0.4; 6 months: 9.1±0.5; 12 months: 8.2±0.4). Normal bone mineral density at distal and ultradistal forearm was maintained during the 1-year treatment (baseline: 0.42±0.01; 12 months: 0.42±0.01 and baseline: 0.33±0.01; 12 months: 0.33±0.01, respectively). Conclusion: The use of tibolone 2.5 mg per day diminished progressively and significantly bone resorption and formation markers during 1-year treatment period.

Postmenopausal women with osteoporosis received 75 mg risedronate on two consecutive days each month or 5 mg daily for 12 months. Changes in bone mineral density and bone turnover markers were similar between treatments. Risedronate 75 mg twice monthly was effective and safe suggesting a new, convenient dosing schedule.

Introduction: Risedronate has been shown to be effective in the treatment of postmenopausal osteoporosis when given orally in daily or weekly doses or on 2 consecutive days per month. This randomized, double-blind, multi-center study was designed to assess the efficacy and safety of a single 150 mg risedronate once-a-month oral dose compared with the 5 mg daily regimen.Methods: Women with postmenopausal osteoporosis were randomly assigned to receive risedronate 5 mg daily (n=642) or 150 mg once a month (followed by daily placebo) (n=650) in a double-blind fashion for 2 years. Study drug was taken on an empty stomach at least 30 min before breakfast. Bone mineral density, bone turnover markers, fractures, and adverse events were evaluated. The primary efficacy endpoint was the mean percent change from baseline in lumbar spine bone mineral density after I year.Results: 538 patients in the daily group (83.8%) and 556 patients in the once-a-month group (85.5%) completed 1 year. The mean percent change in lumbar spine bone mineral density was 3.4% (95% confidence interval, 3.03% to 3.82%) in the daily group and 3.5% (95% confidence interval, 3.15% to 3.93%) in the once-a-month group. The difference between groups was -0.1% (95% confidence interval, -0.51% to 0.27%). The once-a-month regimen was determined to be non-inferior to the daily regimen based on prospectively defined criteria. The mean percent changes in bone mineral density at sites in the hip (total proximal femur, femoral neck, femoral trochanter) were also similar in both dose groups, as were the changes in biochemical markers of bone turnover. The incidence of adverse events, adverse events leading to withdrawal, and upper gastrointestinal tract adverse events were similar in the 2 treatment groups. Both regimens were well tolerated; the percent of patients who withdrew from treatment as a result of an adverse event was 9.5% in the daily group and 8.6% in the once-a-month group.Conclusions: Risedronate 150 mg once a month is similar in efficacy and safety to daily dosing and may provide an alternative for patients who prefer once-a-month oral dosing. (C) 2007 Elsevier Inc. All rights reserved.

One of the treatment goals for ulcerative colitis (UC) is to induce remission. Currently, there is no standard/accepted definition of remission for UC. Thus, the definition of remission differs among clinical trials supporting various therapies for UC. The purpose of this analysis was to estimate remission rates using several different definitions of remission. Data from two Phase III, multicenter, randomized, double-blind, 6-week, controlled studies of similar design (ASCEND I and II) were pooled and analyzed using different definitions of remission. Definitions varied from complete resolution of clinical assessments to still having mild UC signs and symptoms. Remission rates of delayed-release oral mesalamine in patients with mildly to moderately active UC taking 2.4 g/day (marketed 400mg tablet) were examined using several different definitions utilized by various UC therapies. A total of 687 patients with mildly to moderately active UC were included in the study, of which 349 received 2.4g/day. Depending on the definition of remission used in the analyses (see table below), the percentage of patients in remission varied from 22-50%. Remission rates vary widely depending on the definition of remission used. As there is no standard/accepted definition of remission for UC, physicians and other healthcare professionals should pay attention and be aware of the definition of remission being utilized when evaluating clinical efficacy.