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. 2006 Nov 1;6(20):1–180.
Study Patient/Drug Effect on BMD Effect on fracture Authors’ conclusion
Alendronate Sawka et al., 2005 (118) Meta-analysis Of Orwell & Ringe
2004
1996–2004
Alendronate vs
placebo or vitamin D
or calcium
Using Bayesian random effects model
OR vertebral fracture in alendronate treated men 0.44 (95% CI, 0.23–0.83) OR nonvertebral fracture 0.6 (95% CI, 0.29–1.44)
Alendronate decreases risk of vertebral fractures in men with low bone mineral or fractures.
Insufficient data for effect on non-vertebral fractures
Orwoll et al., 2000 (213)
Double blind RCT
Men mean age 63 yrs with femoral neck T-score>/= –2 or L-spine T-score< –1
(Alendronate 10 mg + Ca+vit D) vs (placebo+Ca+vit D) (N= 146/95)
Follow-up = 2 years
BMD increase significantly ↑ 7.15 in lumbar spine & 2.5% in femoral neck in Alendronate vs ↑ of 1.8% in L-spine & 0.6% @ hip of placebo. BMD significantly higher in Alendronate group @ each site. 3% alendronate vs 13% control had >/=10 mm height loss
Vertebral fractures 0.8% alendronate vs7.1% control (P = 0.02) Effect independentof age.
Significantly lower bone marker level in alendronate group
Ringe et al., 2004 (200)
Open label RCT
Men with primary osteoporosis
Alendronate 10 mg vs alfacalciferol
(N = 68/66)
Mean age 52.1/53.3 @ 3 years (58/60 completed treatment)
BMD over baseline
L-spine 11.5% alendronate vs 3.5 control (P = .0001)
Femoral neck 5.8% vs 2.3% (P = .0015) 87% of alendronate vs 46% of control group had increase in spine BMD>/=3%, 63% vs 33% had increase in hip BMD>/=3%
Vertebral fractures occurred in 10.3% alendronate vs 24.2% control (P = .04)
57% reduction in vertebral fracture risk Change in height: –7.1mm in alendronate vs 13.1mm in control (P = .03)
No significant difference in nonvertebral fractures
Both treatments well tolerated. Hypercalciuria reported in 15.1% control vs 4.4% alendronate (P = .04)
Gonnelli et al., 2003 (119)
RCT
Primary osteoporosis Alendronate 10 mg+ Ca vs Ca alone (n=39/38)
3 years
Alendronate group significant increase in spine BMD in each of 3 yrs of follow-up 4.2-8.8% Increased total hip BMD only significant in year 3 (3.9%) BMD at lumbar spine appear to be the best method for monitoring effect of alendronate on bone mass in osteoporotic men (> least significant change al each year).
Risedronate
Sato et al., 2005 (121)
Double blind
RCT
Ambulatory men after stroke >/=65 yrs
Risedronate 2.5 mg oral vs placebo (n=140/140)
18 months
BMD Alendronate group +2.5% vs control –3.5% (P<.001) Serum Ca+ decreased & PTH & 1,25(0H)2 increased in risedronate group but stayed low in control Number of fall similar
Hip fracture 2/140 inrisedronate vs
10/140 control RR 0.19 (95% CI, 0.04–0.89)
NNT for hip fracture16 (9–32)
Ringe et al., 2006 (122)
Single centre open label RCT
Men with primary & secondary osteoporosis (Risedronate 5 mg+1g Ca & vitamin D) vs (placebo)
N= 158/158
Mean age 55.8 yrs vs
58 yrs(NS)
12 months
Increase in spine BMD Risedronate 4.7% vs 1% control (P<.0001) Total hip BMD +2.7
%vs +0.4%
Femoral neck 1.8% vs 0.2% (P <.0001)
New vertebral fractures risedronate 5.1% vs 12.7% control (P = .028)
No significant difference in non-vertebral fracture risk.
Height change 1.1mm risedronate vs –4.6mm control
Improvement in back pain greater in risedronate than control (P < .0001)
*

Ca refers to calcium; L-spine, lumbar spine; OR, odds ratio.