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

Affiliations
  • 1Department of Obstetrics and Gynecology, Chosun University Hospital, Gwangju, Korea. bimilo@hanmail.net
  • 2Department of Nursing, Honam University, Gwangju, Korea.
  • 3Department of Obstetrics and Gynecology, Chosun University School of Medicine, Gwangju, Korea.

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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