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Safety and efficacy of risedronate in reducing fracture risk in osteoporotic women aged 80 and older: implications for the use of antiresorptive agents in the old and oldest old.
J Am Geriatr Soc. 2004 Nov; 52(11):1832-9.JA

Abstract

OBJECTIVES

To determine the efficacy of risedronate in reducing vertebral fracture risk in women aged 80 and older with osteoporosis.

DESIGN

Pooled analysis of data from three randomized, double-blind, controlled, 3-year-fracture-endpoint trials conducted from November 1993 to April 1998: Hip Intervention Program (HIP), Vertebral Efficacy with Risedronate Therapy-Multinational (VERT-MN), and VERT-North America (NA).

SETTING

Office-based practices, research centers, and osteoporosis clinics in Europe, North America, and Australia.

PARTICIPANTS

Osteoporotic (femoral neck bone mineral density T-score < -2.5 standard deviations or at least one prevalent vertebral fracture) women aged 80 and older.

INTERVENTION

Patients received placebo (n=688) or risedronate 5 mg/d (n=704) for up to 3 years. All patients received 1,000 mg/d calcium and, if baseline levels were low, up to 500 IU/d vitamin D.

MEASUREMENTS

Cumulative incidence of new vertebral fractures.

RESULTS

After 1 year, the risk of new vertebral fractures in the risedronate group was 81% lower than with placebo (95% confidence interval=60-91%; P<.001). The number of women who needed to be treated to prevent one new vertebral fracture after 1 year was 12. This early onset of efficacy was consistent across the clinical programs, and antifracture efficacy was confirmed over 3 years. Risedronate was well tolerated, with a safety profile comparable with that of placebo.

CONCLUSION

These findings provide the first evidence that, even in the very old, reducing bone resorption rate remains an effective treatment strategy for osteoporosis. Because each therapeutic agent used for the treatment of osteoporosis may have unique characteristics, the observations made in this study should not be assumed to apply to other bisphosphonates.

Authors+Show Affiliations

Leuven University Center for Metabolic Bone Diseases and Division of Geriatric Medicine, Katholieke Universiteit Leuven, Herestraat 49, B-3000 Leuven, Belgium.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15507059

Citation

Boonen, Steven, et al. "Safety and Efficacy of Risedronate in Reducing Fracture Risk in Osteoporotic Women Aged 80 and Older: Implications for the Use of Antiresorptive Agents in the Old and Oldest Old." Journal of the American Geriatrics Society, vol. 52, no. 11, 2004, pp. 1832-9.
Boonen S, McClung MR, Eastell R, et al. Safety and efficacy of risedronate in reducing fracture risk in osteoporotic women aged 80 and older: implications for the use of antiresorptive agents in the old and oldest old. J Am Geriatr Soc. 2004;52(11):1832-9.
Boonen, S., McClung, M. R., Eastell, R., El-Hajj Fuleihan, G., Barton, I. P., & Delmas, P. (2004). Safety and efficacy of risedronate in reducing fracture risk in osteoporotic women aged 80 and older: implications for the use of antiresorptive agents in the old and oldest old. Journal of the American Geriatrics Society, 52(11), 1832-9.
Boonen S, et al. Safety and Efficacy of Risedronate in Reducing Fracture Risk in Osteoporotic Women Aged 80 and Older: Implications for the Use of Antiresorptive Agents in the Old and Oldest Old. J Am Geriatr Soc. 2004;52(11):1832-9. PubMed PMID: 15507059.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and efficacy of risedronate in reducing fracture risk in osteoporotic women aged 80 and older: implications for the use of antiresorptive agents in the old and oldest old. AU - Boonen,Steven, AU - McClung,Michael R, AU - Eastell,Richard, AU - El-Hajj Fuleihan,Ghada, AU - Barton,Ian P, AU - Delmas,Pierre, PY - 2004/10/28/pubmed PY - 2004/12/16/medline PY - 2004/10/28/entrez SP - 1832 EP - 9 JF - Journal of the American Geriatrics Society JO - J Am Geriatr Soc VL - 52 IS - 11 N2 - OBJECTIVES: To determine the efficacy of risedronate in reducing vertebral fracture risk in women aged 80 and older with osteoporosis. DESIGN: Pooled analysis of data from three randomized, double-blind, controlled, 3-year-fracture-endpoint trials conducted from November 1993 to April 1998: Hip Intervention Program (HIP), Vertebral Efficacy with Risedronate Therapy-Multinational (VERT-MN), and VERT-North America (NA). SETTING: Office-based practices, research centers, and osteoporosis clinics in Europe, North America, and Australia. PARTICIPANTS: Osteoporotic (femoral neck bone mineral density T-score < -2.5 standard deviations or at least one prevalent vertebral fracture) women aged 80 and older. INTERVENTION: Patients received placebo (n=688) or risedronate 5 mg/d (n=704) for up to 3 years. All patients received 1,000 mg/d calcium and, if baseline levels were low, up to 500 IU/d vitamin D. MEASUREMENTS: Cumulative incidence of new vertebral fractures. RESULTS: After 1 year, the risk of new vertebral fractures in the risedronate group was 81% lower than with placebo (95% confidence interval=60-91%; P<.001). The number of women who needed to be treated to prevent one new vertebral fracture after 1 year was 12. This early onset of efficacy was consistent across the clinical programs, and antifracture efficacy was confirmed over 3 years. Risedronate was well tolerated, with a safety profile comparable with that of placebo. CONCLUSION: These findings provide the first evidence that, even in the very old, reducing bone resorption rate remains an effective treatment strategy for osteoporosis. Because each therapeutic agent used for the treatment of osteoporosis may have unique characteristics, the observations made in this study should not be assumed to apply to other bisphosphonates. SN - 0002-8614 UR - https://www.unboundmedicine.com/medline/citation/15507059/Safety_and_efficacy_of_risedronate_in_reducing_fracture_risk_in_osteoporotic_women_aged_80_and_older:_implications_for_the_use_of_antiresorptive_agents_in_the_old_and_oldest_old_ L2 - https://onlinelibrary.wiley.com/resolve/openurl?genre=article&amp;sid=nlm:pubmed&amp;issn=0002-8614&amp;date=2004&amp;volume=52&amp;issue=11&amp;spage=1832 DB - PRIME DP - Unbound Medicine ER -