J Menopausal Med.  2017 Apr;23(1):56-62. 10.6118/jmm.2017.23.1.56.

Combination Therapy of Raloxifene and Alendronate for Treatment of Osteoporosis in Elderly Women

• Um MJ
• Cho EA
• Jung H

• KMID: 2378225
• DOI: http://doi.org/10.6118/jmm.2017.23.1.56

Abstract

OBJECTIVES
To evaluate and compare the efficacy and safety of the combination of raloxifene and alendronate with those of monotherapies in elderly women with osteoporosis.
METHODS
Sixty-two postmenopausal women (mean age 63.5 ± 0.5 years) attending gynecologic osteoporosis clinics with established osteoporosis were randomly allocated to one of four treatment groups and monitored for 3 years. All patients enrolled in this study, including those in the control group (n = 14), received 1.0 g elemental calcium and 400 units of vitamin D per day. The raloxifene group (n = 16) received raloxifene 60 mg (Evista®) per day; alendronate group (n = 17) received low-dose (5 mg) alendronate with calcitriol 0.5 µg (Maxmarvil®) per day; and the combination therapy group (n = 15) received both raloxifene 60 mg and low-dose (5 mg) alendronate with calcitriol 0.5 µg. Bone mineral density (BMD) was measured in the lumbar spine and hip before and after 3 years of treatment.
RESULTS
In patients who received the combined therapy, BMD increased in the lumbar spine and the hip by 7.2% (P<0.001) and 4.8% (P<0.001) at 3 years. For patients in the alendronate group, the increases were 6.7% (P<0.001) and 3.1% (P<0.01) respectively, for the raloxifene group, the increases were 4.36% (P<0.001) and 1.9% (P<0.05) in the vertebrae and femora, respectively; however, the BMD of patients in the control group decreased by 1.81% (P<0.05) and 1.6% (P<0.05), respectively, after 3 years. Patients who received the combination therapy had significantly higher BMD in both the vertebrae femora (P<0.01) in comparison to that in those treated with raloxifene or alendronate individually.
CONCLUSIONS
This 3-year randomized study showed the improved effects of alendronate and raloxifene combination on spine and hip BMD in elderly postmenopausal women with established osteoporosis.

Keyword

Alendronate; Bone mineral density; Raloxifene

MeSH Terms

Aged*
Alendronate*
Bone Density
Calcitriol
Calcium
Female
Hip
Humans
Osteoporosis*
Raloxifene Hydrochloride*
Spine
Vitamin D
Alendronate
Calcitriol
Calcium
Raloxifene Hydrochloride
Vitamin D

Figure

• 

  Fig. 1 Percentage changes in urine N-terminal telopeptide/creatinine and serum osteocalcin at each time point. Filled diamonds, raloxifene (RLX) only group; filled squares alendronate (ALN) only group; filled triangles, RLX plus ALN group. P < 0.05 compared with baseline.

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