Analgesic effect of salmon calcitonin suppositories in patients with
acute pain due to recent osteoporotic vertebral crush fractures: A
prospective double-blind, randomized, placebo-controlled clinical study
Objective: To evaluate the analgesic efficacy of calcitonin
suppositories (200 IU)in comparison with bed rest and paracetamol
tablets, as a rescue analgesic.
Design: A prospective, double-blind, randomized, placebo-controlled,
clinical trial.
Patients: Forty patients (8 men and 32 postmenopausal women), who had
recently (within the last 5 days) suffered a nontraumatic osteoporotic
vertebral fracture.
Setting and Interventions: All patients were admitted to the hospital,
divided randomly into two groups and received either one calcitonin or
placebo suppository once a day, respectively, for 28 days. All patients
were allowed to take paracetamol tablets (500 mg), with a maximum dose
of six tablets daily.
Outcome Measures: Spinal pain evaluation was performed at the beginning
of the study (before the initiation of treatment) and then daily until
the end of the study (day 28) using the Huskinsson’s visual analog scale
(VAS) and a painmeter device, by direct pressure on the fractured
vertebra. Pain was evaluated with the patients attempting or performing
four different locomotor functions, e.g., bed rest, sitting, standing,
and walking functions. Biochemical urine and plasma measurements were
carried out before the initiation of treatment and on days 14 and 28.
Results: All calcitonin-treated patients experienced an overall
statistically significant tall p values < 0.001) decrease of spinal pain
as assessed by the VAS and the painmeter device. Pain relief allowed for
early mobilization and the gradual restoration of the locomotive
functions in the calcitonin-treated group. Placebo-treated patients
remained in bed for almost the whole of the observation period. At the
end of the study (28th day), Fasting osteocalcin,
hydroxyproline/creatinine, and calcium/creatinine ratio values were
statistically significantly (all p values < 0.001), lower in the
calcitonin-treated than in the placebo-treated patients. In the placebo
group these values showed a gradual increase. In the calcitonin-treated
group side effects mainly included dizziness and enteric irritation
caused by the suppositories. Enteric irritation was also present in the
placebo-treated group.
Conclusions: Salmon calcitonin suppositories (200 TU daily) caused a
dramatic decrease in spinal pain in patients with recent osteoporotic
vertebral fractures and influenced the early mobilization and the
gradual restoration of their locomotor functions
