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.