A randomized, placebo-controlled, 6-month study of once-weekly alendronate oral solution for postmenopausal osteoporosis

Byron Cryer, Neil Binkley, Christine Simonelli, E. Michael Lewiecki, Frank Lanza, Erluo Chen, Richard A. Petruschke, Christine Mullen, Anne E. de Papp

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Objective: This study evaluated the overall safety and tolerability of once-weekly (OW) alendronate 70 mg oral solution (OS) versus OW placebo OS. Methods: Postmenopausal, osteoporotic women were enrolled at 51 centers in the United States in a 6-month double-blind, randomized trial. Patients were randomized (1:1) to OW alendronate 70 mg OS or placebo OS. The primary end point was the proportion of patients reporting any upper gastrointestinal (UGI) adverse event (AE) at 6 months. Secondary end points included mean percentage change in urinary N-telopeptide of type I human collagen (NTx) and serum bone-specific alkaline phosphatase (BSAP) at 6 months. Results: Initially, 454 women were enrolled; 392 (8 6.3%) completed the study. The mean (SD) age was 65.2 (10) years, and the mean (SD) time since menopause was 19.1 (12) years. The proportion of patients experiencing any UGI AE was significantly higher with alendronate OS (23.7%) compared with placebo solution (15.3%), with a treatment difference of 8.3% (95% CI, 0.8%-15.8%; P = 0.024). The proportion of patients experiencing any esophageal AE was 4.0% with alendronate and 3.0% with placebo (treatment difference, 1.0% [95% CI, -2.7% to 4.8%]). In addition, 4.5% of alendronate and 8.7% of placebo patients discontinued the study due to any clinical AE, and 3.3% of alendronate and 1.8% of placebo patients discontinued due to a UGI AE (difference, 1.5% [95% CI, -1.5% to 4.4%]). Alendronate OS produced significantly greater reductions in both NTx and BSAP than placebo (differences, -47.5% and -38.7%, respectively [both, P < 0.001]). Conclusions: In this 6-month study, patients receiving OW alendronate 70 mg OS had a higher rate of UGI AEs than placebo patients. However, rates of serious UGI AEs, discontinuations due to UGI AEs, and esophageal AEs were similar between groups. UGI AEs in the study were generally mild to moderate in severity and did not result in treatment discontinuation. In addition, OW alendronate 70 mg OS significantly reduced biochemical markers of bone turnover.

Original languageEnglish (US)
Pages (from-to)127-136
Number of pages10
JournalAmerican Journal Geriatric Pharmacotherapy
Volume3
Issue number3
DOIs
StatePublished - Sep 2005

Fingerprint

Alendronate
Postmenopausal Osteoporosis
Placebos
Alkaline Phosphatase
Bone and Bones
Bone Remodeling
Menopause
Therapeutics
Biomarkers
Safety

Keywords

  • Adverse events
  • Alendronate
  • Biochemical markers
  • Once-weekly
  • Oral solution
  • Tolerability
  • Upper gastrointestinal

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)
  • Geriatrics and Gerontology

Cite this

A randomized, placebo-controlled, 6-month study of once-weekly alendronate oral solution for postmenopausal osteoporosis. / Cryer, Byron; Binkley, Neil; Simonelli, Christine; Lewiecki, E. Michael; Lanza, Frank; Chen, Erluo; Petruschke, Richard A.; Mullen, Christine; de Papp, Anne E.

In: American Journal Geriatric Pharmacotherapy, Vol. 3, No. 3, 09.2005, p. 127-136.

Research output: Contribution to journalArticle

Cryer, Byron ; Binkley, Neil ; Simonelli, Christine ; Lewiecki, E. Michael ; Lanza, Frank ; Chen, Erluo ; Petruschke, Richard A. ; Mullen, Christine ; de Papp, Anne E. / A randomized, placebo-controlled, 6-month study of once-weekly alendronate oral solution for postmenopausal osteoporosis. In: American Journal Geriatric Pharmacotherapy. 2005 ; Vol. 3, No. 3. pp. 127-136.
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title = "A randomized, placebo-controlled, 6-month study of once-weekly alendronate oral solution for postmenopausal osteoporosis",
abstract = "Objective: This study evaluated the overall safety and tolerability of once-weekly (OW) alendronate 70 mg oral solution (OS) versus OW placebo OS. Methods: Postmenopausal, osteoporotic women were enrolled at 51 centers in the United States in a 6-month double-blind, randomized trial. Patients were randomized (1:1) to OW alendronate 70 mg OS or placebo OS. The primary end point was the proportion of patients reporting any upper gastrointestinal (UGI) adverse event (AE) at 6 months. Secondary end points included mean percentage change in urinary N-telopeptide of type I human collagen (NTx) and serum bone-specific alkaline phosphatase (BSAP) at 6 months. Results: Initially, 454 women were enrolled; 392 (8 6.3{\%}) completed the study. The mean (SD) age was 65.2 (10) years, and the mean (SD) time since menopause was 19.1 (12) years. The proportion of patients experiencing any UGI AE was significantly higher with alendronate OS (23.7{\%}) compared with placebo solution (15.3{\%}), with a treatment difference of 8.3{\%} (95{\%} CI, 0.8{\%}-15.8{\%}; P = 0.024). The proportion of patients experiencing any esophageal AE was 4.0{\%} with alendronate and 3.0{\%} with placebo (treatment difference, 1.0{\%} [95{\%} CI, -2.7{\%} to 4.8{\%}]). In addition, 4.5{\%} of alendronate and 8.7{\%} of placebo patients discontinued the study due to any clinical AE, and 3.3{\%} of alendronate and 1.8{\%} of placebo patients discontinued due to a UGI AE (difference, 1.5{\%} [95{\%} CI, -1.5{\%} to 4.4{\%}]). Alendronate OS produced significantly greater reductions in both NTx and BSAP than placebo (differences, -47.5{\%} and -38.7{\%}, respectively [both, P < 0.001]). Conclusions: In this 6-month study, patients receiving OW alendronate 70 mg OS had a higher rate of UGI AEs than placebo patients. However, rates of serious UGI AEs, discontinuations due to UGI AEs, and esophageal AEs were similar between groups. UGI AEs in the study were generally mild to moderate in severity and did not result in treatment discontinuation. In addition, OW alendronate 70 mg OS significantly reduced biochemical markers of bone turnover.",
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T1 - A randomized, placebo-controlled, 6-month study of once-weekly alendronate oral solution for postmenopausal osteoporosis

AU - Cryer, Byron

AU - Binkley, Neil

AU - Simonelli, Christine

AU - Lewiecki, E. Michael

AU - Lanza, Frank

AU - Chen, Erluo

AU - Petruschke, Richard A.

AU - Mullen, Christine

AU - de Papp, Anne E.

PY - 2005/9

Y1 - 2005/9

N2 - Objective: This study evaluated the overall safety and tolerability of once-weekly (OW) alendronate 70 mg oral solution (OS) versus OW placebo OS. Methods: Postmenopausal, osteoporotic women were enrolled at 51 centers in the United States in a 6-month double-blind, randomized trial. Patients were randomized (1:1) to OW alendronate 70 mg OS or placebo OS. The primary end point was the proportion of patients reporting any upper gastrointestinal (UGI) adverse event (AE) at 6 months. Secondary end points included mean percentage change in urinary N-telopeptide of type I human collagen (NTx) and serum bone-specific alkaline phosphatase (BSAP) at 6 months. Results: Initially, 454 women were enrolled; 392 (8 6.3%) completed the study. The mean (SD) age was 65.2 (10) years, and the mean (SD) time since menopause was 19.1 (12) years. The proportion of patients experiencing any UGI AE was significantly higher with alendronate OS (23.7%) compared with placebo solution (15.3%), with a treatment difference of 8.3% (95% CI, 0.8%-15.8%; P = 0.024). The proportion of patients experiencing any esophageal AE was 4.0% with alendronate and 3.0% with placebo (treatment difference, 1.0% [95% CI, -2.7% to 4.8%]). In addition, 4.5% of alendronate and 8.7% of placebo patients discontinued the study due to any clinical AE, and 3.3% of alendronate and 1.8% of placebo patients discontinued due to a UGI AE (difference, 1.5% [95% CI, -1.5% to 4.4%]). Alendronate OS produced significantly greater reductions in both NTx and BSAP than placebo (differences, -47.5% and -38.7%, respectively [both, P < 0.001]). Conclusions: In this 6-month study, patients receiving OW alendronate 70 mg OS had a higher rate of UGI AEs than placebo patients. However, rates of serious UGI AEs, discontinuations due to UGI AEs, and esophageal AEs were similar between groups. UGI AEs in the study were generally mild to moderate in severity and did not result in treatment discontinuation. In addition, OW alendronate 70 mg OS significantly reduced biochemical markers of bone turnover.

AB - Objective: This study evaluated the overall safety and tolerability of once-weekly (OW) alendronate 70 mg oral solution (OS) versus OW placebo OS. Methods: Postmenopausal, osteoporotic women were enrolled at 51 centers in the United States in a 6-month double-blind, randomized trial. Patients were randomized (1:1) to OW alendronate 70 mg OS or placebo OS. The primary end point was the proportion of patients reporting any upper gastrointestinal (UGI) adverse event (AE) at 6 months. Secondary end points included mean percentage change in urinary N-telopeptide of type I human collagen (NTx) and serum bone-specific alkaline phosphatase (BSAP) at 6 months. Results: Initially, 454 women were enrolled; 392 (8 6.3%) completed the study. The mean (SD) age was 65.2 (10) years, and the mean (SD) time since menopause was 19.1 (12) years. The proportion of patients experiencing any UGI AE was significantly higher with alendronate OS (23.7%) compared with placebo solution (15.3%), with a treatment difference of 8.3% (95% CI, 0.8%-15.8%; P = 0.024). The proportion of patients experiencing any esophageal AE was 4.0% with alendronate and 3.0% with placebo (treatment difference, 1.0% [95% CI, -2.7% to 4.8%]). In addition, 4.5% of alendronate and 8.7% of placebo patients discontinued the study due to any clinical AE, and 3.3% of alendronate and 1.8% of placebo patients discontinued due to a UGI AE (difference, 1.5% [95% CI, -1.5% to 4.4%]). Alendronate OS produced significantly greater reductions in both NTx and BSAP than placebo (differences, -47.5% and -38.7%, respectively [both, P < 0.001]). Conclusions: In this 6-month study, patients receiving OW alendronate 70 mg OS had a higher rate of UGI AEs than placebo patients. However, rates of serious UGI AEs, discontinuations due to UGI AEs, and esophageal AEs were similar between groups. UGI AEs in the study were generally mild to moderate in severity and did not result in treatment discontinuation. In addition, OW alendronate 70 mg OS significantly reduced biochemical markers of bone turnover.

KW - Adverse events

KW - Alendronate

KW - Biochemical markers

KW - Once-weekly

KW - Oral solution

KW - Tolerability

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