Abstract
Objectives To assess the efficacy of once-yearly zoledronic acid (ZOL) 5 mg in increasing bone mineral density (BMD) in men with a recent hip fracture participating in the Health Outcomes and Reduced Incidence with Zoledronic Acid Once- Yearly Recurrent Fracture Trial and to compare the efficacy with that in women from the same study. Design Randomized, placebo-controlled, double-blind trial. Setting International multicenter. Participants Five hundred and eight men and 1,619 women within 90 days of surgical repair of low-trauma hip fracture in the same study (for comparison). Intervention Once-yearly intravenous (IV) ZOL 5 mg (n = 248) or placebo (n = 260), loading dose of vitamin D, daily calcium, and vitamin D supplements. Measurement Changes in BMD. Results Percentage change from baseline in total hip BMD at Months 12 and 24 was significantly higher with ZOL than with placebo (between-group difference, 2.0%, P =.003, and 3.8%, P =.002, respectively). Percentage change from baseline in femoral neck BMD at Month 24 was significantly higher with ZOL than with placebo (3.8%, P =.003). The BMD benefit was comparable with that observed in women in this study. New clinical fractures occurred in 36 (7.1%) participants (ZOL, n = 16; placebo, n = 20; P =.64). The ZOL safety profile was comparable with that of placebo, with no significant differences in cardiovascular or long-term renal function and a trend toward lower mortality in ZOL-treated men. Conclusion Once-yearly IV ZOL 5 mg increases bone mass at the hip and femoral neck in men within 90 days of repair of a low-trauma hip fracture. Increases were of a similar magnitude to those observed in women in the same study.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 2084-2090 |
| Number of pages | 7 |
| Journal | Journal of the American Geriatrics Society |
| Volume | 59 |
| Issue number | 11 |
| DOIs | |
| State | Published - Nov 2011 |
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Keywords
- bone mineral density
- hip fracture
- men
- once-yearly
- osteoporosis
ASJC Scopus subject areas
- Geriatrics and Gerontology
Cite this
Once-yearly zoledronic acid in older men compared with women with recent hip fracture. / Boonen, Steven; Orwoll, Eric; Magaziner, Jay; Colõn-Emeric, Cathleen S.; Adachi, Jonathan D.; Bucci-Rechtweg, Christina; Haentjens, Patrick; Kaufman, Jean Marc; Rizzoli, Rene; Vanderschueren, Dirk; Claessens, Frank; Sermon, An; Witvrouw, Richard; Milisen, Koen; Su, Guoqin; Lyles, Kenneth W.
In: Journal of the American Geriatrics Society, Vol. 59, No. 11, 11.2011, p. 2084-2090.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Once-yearly zoledronic acid in older men compared with women with recent hip fracture
AU - Boonen, Steven
AU - Orwoll, Eric
AU - Magaziner, Jay
AU - Colõn-Emeric, Cathleen S.
AU - Adachi, Jonathan D.
AU - Bucci-Rechtweg, Christina
AU - Haentjens, Patrick
AU - Kaufman, Jean Marc
AU - Rizzoli, Rene
AU - Vanderschueren, Dirk
AU - Claessens, Frank
AU - Sermon, An
AU - Witvrouw, Richard
AU - Milisen, Koen
AU - Su, Guoqin
AU - Lyles, Kenneth W.
PY - 2011/11
Y1 - 2011/11
N2 - Objectives To assess the efficacy of once-yearly zoledronic acid (ZOL) 5 mg in increasing bone mineral density (BMD) in men with a recent hip fracture participating in the Health Outcomes and Reduced Incidence with Zoledronic Acid Once- Yearly Recurrent Fracture Trial and to compare the efficacy with that in women from the same study. Design Randomized, placebo-controlled, double-blind trial. Setting International multicenter. Participants Five hundred and eight men and 1,619 women within 90 days of surgical repair of low-trauma hip fracture in the same study (for comparison). Intervention Once-yearly intravenous (IV) ZOL 5 mg (n = 248) or placebo (n = 260), loading dose of vitamin D, daily calcium, and vitamin D supplements. Measurement Changes in BMD. Results Percentage change from baseline in total hip BMD at Months 12 and 24 was significantly higher with ZOL than with placebo (between-group difference, 2.0%, P =.003, and 3.8%, P =.002, respectively). Percentage change from baseline in femoral neck BMD at Month 24 was significantly higher with ZOL than with placebo (3.8%, P =.003). The BMD benefit was comparable with that observed in women in this study. New clinical fractures occurred in 36 (7.1%) participants (ZOL, n = 16; placebo, n = 20; P =.64). The ZOL safety profile was comparable with that of placebo, with no significant differences in cardiovascular or long-term renal function and a trend toward lower mortality in ZOL-treated men. Conclusion Once-yearly IV ZOL 5 mg increases bone mass at the hip and femoral neck in men within 90 days of repair of a low-trauma hip fracture. Increases were of a similar magnitude to those observed in women in the same study.
AB - Objectives To assess the efficacy of once-yearly zoledronic acid (ZOL) 5 mg in increasing bone mineral density (BMD) in men with a recent hip fracture participating in the Health Outcomes and Reduced Incidence with Zoledronic Acid Once- Yearly Recurrent Fracture Trial and to compare the efficacy with that in women from the same study. Design Randomized, placebo-controlled, double-blind trial. Setting International multicenter. Participants Five hundred and eight men and 1,619 women within 90 days of surgical repair of low-trauma hip fracture in the same study (for comparison). Intervention Once-yearly intravenous (IV) ZOL 5 mg (n = 248) or placebo (n = 260), loading dose of vitamin D, daily calcium, and vitamin D supplements. Measurement Changes in BMD. Results Percentage change from baseline in total hip BMD at Months 12 and 24 was significantly higher with ZOL than with placebo (between-group difference, 2.0%, P =.003, and 3.8%, P =.002, respectively). Percentage change from baseline in femoral neck BMD at Month 24 was significantly higher with ZOL than with placebo (3.8%, P =.003). The BMD benefit was comparable with that observed in women in this study. New clinical fractures occurred in 36 (7.1%) participants (ZOL, n = 16; placebo, n = 20; P =.64). The ZOL safety profile was comparable with that of placebo, with no significant differences in cardiovascular or long-term renal function and a trend toward lower mortality in ZOL-treated men. Conclusion Once-yearly IV ZOL 5 mg increases bone mass at the hip and femoral neck in men within 90 days of repair of a low-trauma hip fracture. Increases were of a similar magnitude to those observed in women in the same study.
KW - bone mineral density
KW - hip fracture
KW - men
KW - once-yearly
KW - osteoporosis
UR - http://www.scopus.com/inward/record.url?scp=81755166222&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=81755166222&partnerID=8YFLogxK
U2 - 10.1111/j.1532-5415.2011.03666.x
DO - 10.1111/j.1532-5415.2011.03666.x
M3 - Article
C2 - 22091563
AN - SCOPUS:81755166222
VL - 59
SP - 2084
EP - 2090
JO - Journal of the American Geriatrics Society
JF - Journal of the American Geriatrics Society
SN - 0002-8614
IS - 11
ER -