Clinical studyA randomized trial of nasal spray salmon calcitonin in postmenopausal women with established osteoporosis: the prevent recurrence of osteoporotic fractures study
Section snippets
Material and methods
This double-blind, placebo-controlled trial was conducted in 42 centers in the United States and five centers in the United Kingdom. A total of 1,255 women were enrolled between February 1991 and July 1993.
Results
More than 3,500 women were screened for study participation, of whom 1,255 were randomly assigned to either placebo (n = 311), salmon calcitonin nasal spray 100 IU (n = 316), 200 IU (n = 316), or 400 IU (n = 312) (Table 1). After adjudication of baseline spine radiographs, 910 women had one to five prevalent vertebral fractures (as specified by the protocol), 269 had no vertebral fractures, and 65 had more than five fractures. Spinal radiographs could not be evaluated in 11 women, who were
Discussion
The results of this 5-year clinical trial show that 200 IU of salmon calcitonin nasal spray per day significantly reduces the risk of new vertebral fractures by 33% to 36% in postmenopausal women with low bone mass or prevalent vertebral fractures. Among women with one to five vertebral fractures at baseline, 11 needed to be treated for 3 years to prevent a new vertebral fracture. The effect on vertebral fractures was accompanied by a modest increase in lumbar spine bone mineral density and a
Acknowledgements
This article is dedicated to the late John H. Carstens, Jr., MD (1945 to 1992), whose foresight and leadership made this clinical program possible, and to Janet Partridge, who was responsible for coordinating and managing the study. We are grateful to Moı̈se Azria, PhD, for his help with the literature search.
PROOF STUDY GROUP:
Jeffrey Miller, Jane Sherman, (Tampa, FL); Douglas Kiel, Jeannette Szaro (Providence, RI); Suthin Songcharoen, Susan Williams (Jackson, MS); Robert Bing-You, Donna
References (53)
- et al.
Ultrastructural effects of calcitonin on osteoclasts in tissue culture
J Ultrastruct Res
(1972) - et al.
Discontinuous calcitonin treatment of established osteoporosis —effects of withdrawal of treatment
Am J Med
(1990) - et al.
1-Year controlled randomized trial of prevention of early postmenopausal bone loss by intranasal calcitonin
Lancet
(1987) - et al.
A double-blind, placebo-controlled, dose-finding trial of intermittent nasal salmon calcitonin for prevention of postmenopausal lumbar spine bone loss
Am J Med
(1995) - et al.
Effect of nasal salmon calcitonin on bone remodeling and bone mass in postmenopausal osteoporosis
Bone
(1996) - et al.
Long-term calcitonin therapy in postmenopausal osteoporosis
Metabolism
(1984) - et al.
Randomized trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group
Lancet
(1996) - et al.
Alendronate treatment of the postmenopausal osteoporotic womaneffect of multiple dosages on bone mass and bone remodeling
Am J Med
(1995) The CalcitoninsPhysiology and Pharmacology
(1989)- et al.
Behavior of osteoclasts during a rapid change in their number induced by high doses of parathyroid hormone or calcitonin in intact rats
Metab Bone Dis Relat Res
(1981)