A Comparison of Continuous Alendronate, Cyclical Alendronate and Cyclical Etidronate with Calcitriol in the Treatment of Postmenopausal Vertebral Osteoporosis: A Randomized Controlled Trial |
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Authors: | O Sahota I Fowler P J Blackwell N Lawson S A Cawte P San T Masud D J Hosking |
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Institution: | (1) Ageing and Disability Research Unit (ADRU), University Hospital, Nottingham; Divisions of ,;(2) Mineral Metabolism, GB;(3) Clinical Chemistry, GB;(4) Nuclear Medicine, GB;(5) Geriatric Medicine, City Hospital, Nottingham, UK, GB |
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Abstract: | A number of drugs are now available for the treatment of established osteoporosis and have been shown to significantly increase
bone mineral density (BMD). There are, however, few comparative treatment studies and, furthermore, adverse events remain
a problem with some of the newer agents, particularly in the elderly, in everyday clinical practice. We report a 12 month,
open labeled, randomized controlled, prospective treatment study in 140 postmenopausal women with established vertebral osteoporosis,
comparing the effect of continuous alendronate, cyclical alendronate and cyclical etidronate with calcitriol in terms of gain
in BMD, reduction in bone turnover markers and adverse event profile. The mean percentage increases in BMD at 12 months, at
the spine and hip respectively, were: continuous alendronate 5.7%, 2.6%; cyclical alendronate 4.1%, 1.6%; cyclical etidronate
4.9%, 2.0% (p<0.01) and calcitriol 2.0%, 0.4% (NS). In comparison with calcitriol, the mean changes in BMD at the spine and hip respectively
were greater in the other groups; continuous alendronate: 3.7% (95% CI 1.4 to 8.3), 2.2% (95% CI 0.7 to 4.0); cyclical alendronate:
2.1% (95% CI 1.2 to 6.4), 1.2% (95% CI −0.3 to 3.0); cyclical etidronate: 2.9% (95% CI 1.9 to 6.5), 1.6% (95% CI 0.9 to 3.1)).
The reduction in bone turnover markers was between 26% and 32% in the alendronate and etidronate groups (p<0.01), with a trend toward greater reduction in the continuous alendronate group. Eight patients discontinued the study:
6 in the continuous alendronate group, 1 in the cyclical alendronate group and 1 in the calcitriol group. Two patients in
the cyclical etidronate group were unable to tolerate the Cacit component, but continued on substituting Cacit with Calcichew.
In summary, 12 months of treatment with continuous alendronate, cyclical alendronate and cyclical etidronate are effective
in terms of the gain in BMD at the anteroposterior spine and total hip in a comparable treatment population. These treatments
are more effective than calcitriol and were generally well tolerated. Continuous alendronate showed a trend toward a larger
gain in BMD and greater suppression of bone turnover markers than the other treatment groups, but had a higher incidence of
adverse events, particularly within the older subgroup. Cyclical alendronate offers a lower adverse event profile and appears
to be effective in comparison with continuous treatment, and may possibly be an alternative in the elderly. However, further
studies are necessary, but more importantly with fracture end-points.
Received: 6 April 1999 / Accepted: 8 June 2000 |
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Keywords: | :Alendronate – Bone mineral density – Calcitriol – Established osteoporosis – Etidronate |
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