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Alendronate/Hormone Replacement Therapy Combination Safe, More Effective Treatment for Osteoporosis in Elderly Women

The combination of bisphosphonate alendronate and hormone replacement therapy gives a greater improvement in hip and spinal bone mineral density in elderly women than either therapy alone, according to a recent American study.

Various types of anti-resorptive drugs are effective at increasing bone mineral density (BMD) and reducing fracture risk in postmenopausal women with osteoporosis. It has been proposed that by combining anti-resorptive agents with different modes of action it may be possible to achieve an even greater effect on BMD and fracture risk. Studies to test this hypothesis have been conducted in younger women and have demonstrated a greater improvement in BMD with combinatorial treatment; however, studies in elderly women that are at a higher risk of osteoporosis have not been conducted.

Susan L. Greenspan, MD, and colleagues in Pittsburgh, Pennsylvania, and Boston, Massachusetts, United States, conducted a randomised clinical trial to test the efficacy and safety of combinatorial hormone replacement and alendronate therapy in community-dwelling elderly women.

Three hundred and seventy-three women between the ages of 65 and 90 were randomised to receive 1 of the following treatments for 3 years: 1) placebo only, 2) alendronate sodium (10 mg/day) plus HRT placebo, 3) alendronate placebo plus HRT, or 4) combinatorial alendronate plus HRT. HRT consisted of equine oestrogen (0.625 mg/day) for all women, but was supplemented with medroxyprogesterone (2.5 mg/day) in women with an intact uterus. All women also received additional vitamin D and calcium tablets.

Overall, the greatest improvement in BMD was observed when patients were treated with a combination of alendronate and HRT. Specifically, after 3 years total hip BMD increased an average 5.9% in the combinatorial group, 4.2% in the alendronate only group, 3.0% in the HRT only group and was maintained in the placebo group. A similar trend was observed for the femoral neck and trochanter.

Spinal BMD increased in all treatment arms, with the greatest increase again in the combinatorial group. Posteroanterior lumbar spine increased 10.4% in this group and only 7.7% for alendronate alone, 7.1% for HRT alone, and 1.1% for placebo.

An increase in the BMD of the ultradistal radius was only observed when combinatorial therapy was administered.

Another observation made was that patients receiving alendronate alone or in combination with HRT had higher response rates than HRT or placebo, suggesting a benefit of alendronate over HRT.

The combinatorial therapy also appeared to be safe and well-tolerated. Similar adverse events were reported in the combinatorial group as in the HRT alone group. Furthermore, no differences in hospitalisations, myocardial infarction, falls or clinical fractures were seen between groups.

"For elderly women in whom hormone or oestrogen replacement is a therapeutic alternative, combination therapy with a bisphosphonate can be considered to further improve skeletal integrity," suggested Dr. Greenspan. Furthermore, it "may be an option for women who fail to achieve an adequate response on monotherapy or for patients with more severe disease for whom monotherapy would be less desirable."
JAMA 2003;289:19:2525-2533. "Combination Therapy With Hormone Replacement and Alendronate for Prevention of Bone Loss in Elderly Women: A Randomized Controlled Trial"

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