A comparison of the effect of alendronate and risedronate on bone mineral density in postmenopausal women with osteoporosis

24-month results from FACTS-International

D. M. Reid, D. Hosking, D. Kendler, M. L. Brandi, J. D. Wark, J. F. Marques-Neto, G. Weryha, N. Verbruggen, C. M. Hustad, E. M. Mahlis, M. E. Melton

Research output: Contribution to journalArticle

30 Citations (Scopus)

Abstract

Objectives: To compare alendronate 70 mg once weekly (OW) with risedronate 35 mg OW with respect to change in bone mineral density (BMD), biochemical markers and upper gastrointestinal (UGI) tolerability over 24 months. 

Methods: This was a 12-month extension to the Fosamax (R) Actonel (R) Comparison Trial international study (FACTS). Postmenopausal women with osteoporosis randomly assigned to either alendronate 70 mg OW or risedronate 35 mg OW for the 12-month base study continued taking the same double-blind study medication. Efficacy measurements were BMD at the hip trochanter, lumbar spine, total hip, and femoral neck and levels of four bone turnover markers at 24 months. The primary hypothesis was that alendronate would produce a greater mean per cent increase from baseline in hip trochanter BMD at 24 months.

Results: Trochanter BMD increased significantly from baseline to month 24 in both groups, with a significantly larger increase with alendronate: adjusted mean treatment difference of 1.50% (95% confidence interval: 0.74%, 2.26%; p < 0.001). Similar results were seen at all BMD sites. Significant geometric mean per cent decreases (p < 0.001) from baseline were seen for all four bone turnover markers in both groups, with significantly larger decreases (p < 0.001) with alendronate: adjusted mean treatment differences ranged from 8.9% to 25.3%. No significant differences were seen in incidence of UGI or other adverse events. 

Conclusions: Alendronate 70 mg OW yielded significantly greater BMD gains and larger decreases in bone turnover marker levels than risedronate 35 mg OW over 24 months, with no difference in UGI tolerability.

Original languageEnglish
Pages (from-to)575-584
Number of pages10
JournalInternational Journal of Clinical Practice
Volume62
Issue number4
Early online date6 Mar 2008
DOIs
Publication statusPublished - Apr 2008

Keywords

  • fracture intervention trial
  • once-weekly alendronate
  • vertebral fractures
  • nonvertebral fractures
  • double-blind
  • antiresorptive agents
  • antifracture efficacy
  • medical literature
  • clinical-trials
  • users guides

Cite this

A comparison of the effect of alendronate and risedronate on bone mineral density in postmenopausal women with osteoporosis : 24-month results from FACTS-International. / Reid, D. M.; Hosking, D.; Kendler, D.; Brandi, M. L.; Wark, J. D.; Marques-Neto, J. F.; Weryha, G.; Verbruggen, N.; Hustad, C. M.; Mahlis, E. M.; Melton, M. E.

In: International Journal of Clinical Practice, Vol. 62, No. 4, 04.2008, p. 575-584.

Research output: Contribution to journalArticle

Reid, DM, Hosking, D, Kendler, D, Brandi, ML, Wark, JD, Marques-Neto, JF, Weryha, G, Verbruggen, N, Hustad, CM, Mahlis, EM & Melton, ME 2008, 'A comparison of the effect of alendronate and risedronate on bone mineral density in postmenopausal women with osteoporosis: 24-month results from FACTS-International', International Journal of Clinical Practice, vol. 62, no. 4, pp. 575-584. https://doi.org/10.1111/j.1742-1241.2008.01704.x
Reid, D. M. ; Hosking, D. ; Kendler, D. ; Brandi, M. L. ; Wark, J. D. ; Marques-Neto, J. F. ; Weryha, G. ; Verbruggen, N. ; Hustad, C. M. ; Mahlis, E. M. ; Melton, M. E. / A comparison of the effect of alendronate and risedronate on bone mineral density in postmenopausal women with osteoporosis : 24-month results from FACTS-International. In: International Journal of Clinical Practice. 2008 ; Vol. 62, No. 4. pp. 575-584.
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abstract = "Objectives: To compare alendronate 70 mg once weekly (OW) with risedronate 35 mg OW with respect to change in bone mineral density (BMD), biochemical markers and upper gastrointestinal (UGI) tolerability over 24 months.  Methods: This was a 12-month extension to the Fosamax (R) Actonel (R) Comparison Trial international study (FACTS). Postmenopausal women with osteoporosis randomly assigned to either alendronate 70 mg OW or risedronate 35 mg OW for the 12-month base study continued taking the same double-blind study medication. Efficacy measurements were BMD at the hip trochanter, lumbar spine, total hip, and femoral neck and levels of four bone turnover markers at 24 months. The primary hypothesis was that alendronate would produce a greater mean per cent increase from baseline in hip trochanter BMD at 24 months. Results: Trochanter BMD increased significantly from baseline to month 24 in both groups, with a significantly larger increase with alendronate: adjusted mean treatment difference of 1.50{\%} (95{\%} confidence interval: 0.74{\%}, 2.26{\%}; p < 0.001). Similar results were seen at all BMD sites. Significant geometric mean per cent decreases (p < 0.001) from baseline were seen for all four bone turnover markers in both groups, with significantly larger decreases (p < 0.001) with alendronate: adjusted mean treatment differences ranged from 8.9{\%} to 25.3{\%}. No significant differences were seen in incidence of UGI or other adverse events.  Conclusions: Alendronate 70 mg OW yielded significantly greater BMD gains and larger decreases in bone turnover marker levels than risedronate 35 mg OW over 24 months, with no difference in UGI tolerability.",
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T1 - A comparison of the effect of alendronate and risedronate on bone mineral density in postmenopausal women with osteoporosis

T2 - 24-month results from FACTS-International

AU - Reid, D. M.

AU - Hosking, D.

AU - Kendler, D.

AU - Brandi, M. L.

AU - Wark, J. D.

AU - Marques-Neto, J. F.

AU - Weryha, G.

AU - Verbruggen, N.

AU - Hustad, C. M.

AU - Mahlis, E. M.

AU - Melton, M. E.

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N2 - Objectives: To compare alendronate 70 mg once weekly (OW) with risedronate 35 mg OW with respect to change in bone mineral density (BMD), biochemical markers and upper gastrointestinal (UGI) tolerability over 24 months.  Methods: This was a 12-month extension to the Fosamax (R) Actonel (R) Comparison Trial international study (FACTS). Postmenopausal women with osteoporosis randomly assigned to either alendronate 70 mg OW or risedronate 35 mg OW for the 12-month base study continued taking the same double-blind study medication. Efficacy measurements were BMD at the hip trochanter, lumbar spine, total hip, and femoral neck and levels of four bone turnover markers at 24 months. The primary hypothesis was that alendronate would produce a greater mean per cent increase from baseline in hip trochanter BMD at 24 months. Results: Trochanter BMD increased significantly from baseline to month 24 in both groups, with a significantly larger increase with alendronate: adjusted mean treatment difference of 1.50% (95% confidence interval: 0.74%, 2.26%; p < 0.001). Similar results were seen at all BMD sites. Significant geometric mean per cent decreases (p < 0.001) from baseline were seen for all four bone turnover markers in both groups, with significantly larger decreases (p < 0.001) with alendronate: adjusted mean treatment differences ranged from 8.9% to 25.3%. No significant differences were seen in incidence of UGI or other adverse events.  Conclusions: Alendronate 70 mg OW yielded significantly greater BMD gains and larger decreases in bone turnover marker levels than risedronate 35 mg OW over 24 months, with no difference in UGI tolerability.

AB - Objectives: To compare alendronate 70 mg once weekly (OW) with risedronate 35 mg OW with respect to change in bone mineral density (BMD), biochemical markers and upper gastrointestinal (UGI) tolerability over 24 months.  Methods: This was a 12-month extension to the Fosamax (R) Actonel (R) Comparison Trial international study (FACTS). Postmenopausal women with osteoporosis randomly assigned to either alendronate 70 mg OW or risedronate 35 mg OW for the 12-month base study continued taking the same double-blind study medication. Efficacy measurements were BMD at the hip trochanter, lumbar spine, total hip, and femoral neck and levels of four bone turnover markers at 24 months. The primary hypothesis was that alendronate would produce a greater mean per cent increase from baseline in hip trochanter BMD at 24 months. Results: Trochanter BMD increased significantly from baseline to month 24 in both groups, with a significantly larger increase with alendronate: adjusted mean treatment difference of 1.50% (95% confidence interval: 0.74%, 2.26%; p < 0.001). Similar results were seen at all BMD sites. Significant geometric mean per cent decreases (p < 0.001) from baseline were seen for all four bone turnover markers in both groups, with significantly larger decreases (p < 0.001) with alendronate: adjusted mean treatment differences ranged from 8.9% to 25.3%. No significant differences were seen in incidence of UGI or other adverse events.  Conclusions: Alendronate 70 mg OW yielded significantly greater BMD gains and larger decreases in bone turnover marker levels than risedronate 35 mg OW over 24 months, with no difference in UGI tolerability.

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KW - nonvertebral fractures

KW - double-blind

KW - antiresorptive agents

KW - antifracture efficacy

KW - medical literature

KW - clinical-trials

KW - users guides

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DO - 10.1111/j.1742-1241.2008.01704.x

M3 - Article

VL - 62

SP - 575

EP - 584

JO - International Journal of Clinical Practice

JF - International Journal of Clinical Practice

SN - 1368-5031

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ER -