Actonel research results

Summaries and in some cases full abstracts of some Actonel research (Risedronate research studies).

1. New Actonel research: Risedronate once monthly: a potential new regimen for the treatment of postmenopausal osteoporosis

   One of the problems with the use of Risendronate for post menopausal Osteoporosis is that patients do not stick with theonce a week dosage. Scientists in Madrid, Spain published astudy in Clinical Intervention Aging in June of 2008 indicating the less frequent dosage would also be effective.

   Their Abstract states: "...These studies are reviewed to demonstrate the efficacy and safety of two different monthly regimens of risedronate in the treatment of postmenopausal osteoporosis: 75 mg on 2 consecutive days a month and 150 mg once a month. Data for oral risedronate 150 mg once a month are limited to 1 year’s treatment duration. In previous clinical trials, patients receiving risedronate 5 mg daily have been followed for up to 7 years, with no evidence of loss of effectiveness. Risedronate 150 mg once a month has a comparable efficacy and safety to daily doses in the treatment of postmenopausal osteoporosis. These additional treatment options with risedronate provide easier dosing alternatives for patients.

2. Effects of risedronate 5 mg/d on bone mineral density and bone turnover markers in late-postmenopausal women with osteopenia: a multinational, 24-month, randomized, double-blind, placebo-controlled, parallel-group, phase III trial. Journal o fclinical Therapy. 2007.

   BACKGROUND: Randomized clinical trials have shown that risedronate reduces the risk for both ver- tebral and nonvertebral fractures in postmenopausal women with osteoporosis (bone mineral density [BMD] T-score, <-2.5). If left untreated, osteopenia (T-score, between -1 and -2.5) may progress to osteo- porosis. Risedronate sodium, a pyridinyl bisphospho- nate, is an antiresorptive drug approved by the US Food and Drug Administration for the prevention and treatment of osteoporosis in postmenopausal women. Although the effects of risedronate in preventing frac- tures has been established, its effects in maintaining or increasing BMD in osteopenia have not. OBJECTIVE: In this clinical trial, the efficacy and tol- erability of risedronate in improving and maintaining BMD levels in late-postmenopausal women with os- teopenia were assessed.

   METHODS: This 24-month, randomized, double- blind, placebo-controlled, parallel-group, Phase III trial was conducted at 14 study centers across Finland, The Netherlands, Norway, Spain, and Sweden. Late- postmenopausal (> or =5 years from menopause) women with lumbar spine (LS) BMD T-score between -1 and -2.5 and the presence of > or =1 additional risk factor for osteo- porosis or proximal femur (Fern) BMD T-score < or = -1 were randomized to receive risedronate 5 mg (n = 114) or placebo (n = 57) PO QD for 24 months. The primary efficacy end point was the percentage change from baseline in LS BMD at study end point (24 months or last observation carried forward). Secondary efficacy end points were the percentage changes from base- line in total proximal Fern BMD and 2 bone turnover markers-urinary type I collagen cross-linked N-telopeptide (uNTx) and serum bone-specific alkaline phosphatase (sBAP)-at 12 months and study end point. Tolerability was assessed using reported adverse events (AEs), laboratory analysis, and physical exami- nation including vital-sign measurements.

   RESULTS: A total of 171 women were included (mean [SD] age, 65.9 [6.8] years; mean [SD] LS BMD T-score,-1.82 [0.42]; risedronate group, 114 patients; placebo group, 57). At study end point, LS BMD had significantly increased from baseline in the risedronate group (P < 0.05) but remained unchanged in the placebo group (mean [SE] %Delta, +4.49% [0.38%] and +0.05% [0.54%], respectively; P < 0.001). Between- treatment differences in mean (SE) percentage changes from baseline in LS BMD and Fem BMD were signif- icant at 12 months and study end point (LS BMD, both P < 0.001; Fem BMD, P = 0.002 and P < 0.001, respectively). At 12 months and study end point, ris- edronate use was associated with significantly reduced concentrations of uNTx and sBAP compared with placebo (both, P < 0.001). Risedronate treatment was well tolerated with regard to gastrointestinal AEs; the most frequent AEs in the risedronate group were hy- pertension (n = 13), constipation (n = 8), and hyper- cholesterolemia (n = 8).

   CONCLUSIONS: In these late-postmenopausal women with LS osteopenia and > or=1 additional risk factor or hip osteopenia, 24-month treatment with risedronate 5 mg/d was associated with the prevention of bone loss at the spine and hip (based on significant increases in BMD in the LS and total proximal Fem) and reduced bone resorption (based on significantly reduced concentrations of uNTx and sBAP) and was well tolerated.

3. Actonel research in men. Sustained efficacy of risedronate (actonel) in men with primary and secondary osteoporosis: results of a 2-year study. by researchers in Cologne, Germany. 2009. "The aim of this study was to assess the effect of treatment with risedronate 5 mg daily relative to control in men with primary or secondary osteoporosis over 2 years. . .

   In an earlier interim report, we found that 1 year of risedronate therapy resulted in significant increases in bone mineral density (BMD) and a significant reduction in vertebral fractures compared to control in men with osteoporosis.

   We conducted an open-label, prospective, match-control trial on men with primary or secondary osteoporosis in a single center, outpatient setting. Men with primary or secondary osteoporosis, as defined by a baseline lumbar spine BMD T-score < or = -2.5 and a baseline femoral neck BMD T-score < or = 2.0, were eligible for this study. Patients who had been treated with bisphosphonates or fluoride within the last 12 months were excluded.

   A total of 316 men were randomized to risedronate (n = 158) or control (n = 158). Patients were stratified by the presence of prevalent vertebral fractures at baseline and case by case allocated to either daily treatment with risedronate 5 mg daily plus calcium (1,000 mg) and vitamin D (800 IU) or to a control group (daily alfacalcidol (1 microg) plus calcium (500 mg) for those with prevalent vertebral fractures; daily vitamin D (800 IU) plus calcium (1,200 mg) for those without previous vertebral fractures).

   Primary study end points were identified prior to study initiation as the incidence of new vertebral fractures and changes in BMD at the lumbar spine, femoral neck, and total hip. Other end points included incidence of nonvertebral fractures and change in body height and back pain. Compared to control, the incidence of new vertebral fractures was significantly reduced in the risedronate 5 mg daily group at 2 years [14/152 (9.2%) for risedronate vs. 35/148 (23.6%) for control (61% risk reduction; P = 0.0026)].

   Treatment with risedronate 5 mg daily also resulted in significant improvements in BMD at 2 years at all three skeletal sites (lumbar spine, 6.5 vs. 2.2%; femoral neck, 3.2 vs. 0.6%; total hip, 4.4 vs. 0.4% (P < 0.001 for all treatment comparisons). Significant reductions in the incidence of nonvertebral fractures (11.8 vs. 22.3%; P = 0.032), average loss in height, and back pain were also observed in risedronate-treated patients relative to control. In this 2-year study, daily 5 mg risedronate significantly reduced the risk of vertebral and nonvertebral fractures, improved BMD, decreased height loss, and reduced back pain in men with osteoporosis. Efficacy was sustained over 2 years; a consistent 60-61% risk reduction in vertebral fractures was observed at 1 and 2 years, respectively. These data demonstrate that daily risedronate is effective long-term therapy for men with primary or secondary osteoporosis."

4. Actonel research:Two-year efficacy and tolerability of risedronate once a week for the treatment of women with post menopausal osteoporosis by Harris ST, Watts NB, Li Z, Chines AA, Hanley DA, Brown JP. University of California, San Francisco, California 94117, USA.

   CONCLUSIONS: "The 2-year data agree with the 1-year results demonstrating that the risedronate once-a-week doses are comparable in efficacy and safety to the 5 mg daily dose. Risedronate 35 mg once a week is considered the optimal dose want a once-a-week dosing regimen."

5. Actonel research Risedronate for the prevention and treatment of postmenopausal osteoporosis . Cranney A, Waldegger L, Zytaruk N, Shea B, Weaver B, Papaioannou A, Robinson V, Wells G, Tugwell P, Adachi JD, Guyatt G. Division of Rheumatology, Queen's University, Etherington Hall (Room 2004), Stuart street, Kingston, Ontario, CANADA, K7L 3N6.

   " BACKGROUND: Postmenopausal osteoporosis results in an increased susceptibility to low-trauma fractures due to reduced bone volume and microarchitectural deterioration. Risedronate, a third generation bisphosphonate, has been shown in multiple clinical trials to reduce fracture risk and improve bone mineral density in postmenopausal women with osteoporosis. First and second generation bisphosphonates are known to have gastrointestinal side-effects and risedronate may be better tolerated."

   "REVIEWER'S CONCLUSIONS: There is good evidence for the efficacy of risedronate in the reduction of both vertebral and non-vertebral fractures. In addition, there is evidence from randomized trials that risedronate is able to achieve this without increasing risk for overall withdrawals due to adverse effects. "

6. Actonel research: Efficacy and acceptability of risedronate 5 mg daily compared with 35 mg weekly for the treatment of postmenopausal women by E. Ilter, H. Karalok, EC Tufekci, O Batur of the Department of Gynecology and Obstetrics, Maltepe University Faculty of Medicine, Istanbul, Turkey and by published in Climacteric in April 2006 concluded that :” 35 mg given once per week has the same therapeutic efficacy and safety as a daily 5 mg regimen. Taking the medicine once a week is likely to be easier and more satisfactory than the daily regimen. However, patients taking a once-a-week regimen may forget to take it due to the 7-day break without medicine.”
7. Actonel research: Importance of calcium co-medication in bisphosphonate therapy of osteoporosis : an approach to improving correct intake and drug adherence. By JD Ringe, SA van der Geest, G. Moller Medical Clinic 4, Klinikum Leverkusen, University of Cologne, Leverkusen, Germany and published in Drugs Aging. 2006.

   CONCLUSIONS: The availability of a fixed-combination pack of risedronic acid 35 mg/week and calcium tablets can increase the likelihood that postmenopausal osteoporotic patients will receive both a bisphosphonate and calcium, which in turn is likely to enhance the correct intake of combination therapy.

You can read the complete abstract of this and other studies about Actonel in Osteopenia or Osteoporosis at PubMed the web site of the National Center for Biotechnology Information by searching for Actonel research

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Page updated: December 2009

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