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Combining Hormone Therapy and Alendronate Has No Bone Mass Benefit over Monotherapy in Elderly Women with Osteoporosis

Hormone replacement therapy (HRT) results in greater increases in bone mineral density (BMD) of the femoral neck, but fewer reductions in bone turnover markers, when compared to alendronate alone or in combination with HRT, according to a double-blind, randomised, 2-year study. Similar increases were seen in total hip and lumbar spine BMD with all treatments.

Both HRT and alendronate have been shown to effectively prevent postmenopausal bone loss and improve bone density. Both are antiresorptive agents, yet they use different mechanisms of action. It has been proposed that women with severe osteoporosis or those who fail to respond to HRT or alendronate alone may have an additive benefit with combinatorial therapy.

Sirpa Evio, MD, and colleagues at the Helsinki University Central Hospital, Finland, compared the use of alendronate, HRT, and their combination in the treatment of osteoporosis in elderly postmenopausal women.

The study included 90 postmenopausal women between the ages of 65 and 80 who had BMD T-scores greater than or equal to 2.5 at the lumbar spine or femoral neck. Patients were randomised to receive alendronate (10 mg/day), estradiol (2 mg/day) plus norethisterone acetate (1 mg/day), or their combination for 2 years. Changes in BMD and markers of bone turnover were measured during treatment.

HRT alone was the only therapy that significantly increased femoral neck BMD from baseline values. HRT increased femoral neck BMD by 4.9% at 12 months and by 5.8% at 24 months (P < .0001). The increase seen at 2 years was significantly greater than the increase seen with either alendronate alone or in combination with HRT.

However, HRT treatment was also associated with significantly smaller decreases in 2 markers of bone turnover, urinary type I collagen aminoterminal telopeptide and serum type I procollagen aminoterminal propeptide.

All treatment groups showed similar increases in lumbar spine and total hip BMD at 2 years. Lumbar spine BMD increases ranged from 6.8-8.4% at 12 months and from 9.1-11.2% at 24 months.

Notably, marker changes explained only 10-15% of BMD changes in all groups.

All treatments were well tolerated. Similar incidences of gastrointestinal adverse events were reported in each group. Breast tenderness led to 5 treatment discontinuation, 2 in the HRT group and 3 in the combination group.

The authors conclude that "the combination of HRT and alendronate did not offer an extra gain of bone mass over either treatment alone in elderly postmenopausal women with osteoporosis." "However, reductions in the levels of bone markers indicated alendronate or the combination to be superior to HRT alone," they add.

J Clin Endocrinol Metab 2004 Feb;89:2:626-31. "Effects of Alendronate and Hormone Replacement Therapy, Alone and in Combination, on Bone Mass and Markers of Bone Turnover in Elderly Women with Osteoporosis"

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