Randomized, double-blind, double-dummy, active- and placebo-controlled, multiple-dose, phase 3 study |
[@64728]
|
Postmenopausal women diagnosed with osteoporosis were divided into 3 groups to receive: oral recombinant salmon calcitonin with placebo nasal spray, synthetic salmon calcitonin nasal spray with placebo tablets, and placebo tablet and placebo spray. |
Women in the oral rsCT group had a greater increase in lumbar spine BMD from baseline than the other two groups and a greater BMD in trochanteric and total proximal femur when compared to just the ssCT group. There were significant reductions in 2/3 bone resorption markers in the rsCT group when compared to the ssCT group, and a reduction in 3/3 markers when rsCT compared to the placebo group. 80% of the participants experienced at least 1 adverse event, and less than 10% in each group experienced a serious adverse event. |
Oral rsCT showed improved BMD and less bone turnover when compared to nasal ssCT or placebo and may be used as alternative therapy in postmenopausal osteoporotic women. Oral rsCT was found to have minimal side effects and is as well tolerated as the ssCT or placebo groups. |
Randomized, double-blind, placebo-controlled phase III study |
[@64729]
|
3310 postmenopausal osteoporotic women were divided into two groups and given either: oral calcitonin or placebo. |
Oral calcitonin does not affect preventing new vertebral fractures, hip, or non-vertebral fractures. There was a slight increase in BMD of the lumbar spine, femoral neck, and hip in both groups. Less bone turnover was noted at 12 and 24 months, but not at 36 months in the oral calcitonin group, with no change in the quality of life between the groups. 92% of all subjects reported an adverse event, most of which were mild or moderate. The oral calcitonin group experienced more nausea, vomiting, abdominal pain, and hot flushes when compared to the placebo. |
This fracture efficacy trial failed to result in any clinical benefit of subjects taking oral calcitonin, attributed to low drug exposure levels. |
Prospective, double-blind, randomized, placebo-controlled, clinical trial |
[@64730]
|
40 patients who recently suffered a non-traumatic osteoporotic vertebral fracture received either a calcitonin or placebo suppository once daily with or without also taking paracetamol (500mg) tablets. |
The calcitonin suppository group experienced less spinal pain, early mobilization, sitting, walking, and standing when compared to the placebo suppository group. There was also less bone turnover in the calcitonin suppository group. |
Salmon calcitonin suppositories caused a significant decrease in spinal pain in patients with nontraumatic osteoporotic vertebral fractures that occurred within 5 days of treatment. This induced return of locomotor functions. |
Nationwide, prospective, multicenter, open-label, randomized controlled trial |
[@64727]
|
Osteoporotic women with acute lumbar pain after a new vertebral compression fracture were divided into two treatment groups: 114 received 20 units of elcatonin injected once weekly, and 114 women received NSAIDs daily for 6 weeks. |
There were statistically significant differences between the two treatment groups measured through the VAS of pain intensity and quality of life measured by the JQ22 and RDQ. The mean differences between the elcatonin group and the NSAIDs group in each measure at 4 and 6 weeks were −4.8 and −8.3 for the JQ22, −1.3 and −2.6 for the RDQ −11.3 and −11.5 for the VAS, in favor of elcatonin. |
Once weekly injections of elcatonin were more efficacious than daily NSAIDs when managing pain and improving mobility after an osteoporotic fracture |
Systematic review and meta-analysis |
[@64731]
|
13 different studies/trials were reviewed and analyzed to study calcitonin as a treatment for acute and chronic pain at rest and while mobile after suffering an osteoporotic vertebral compression fracture. The studies included:
4 trials studied acute pain at rest, four trials studied acute pain with mobility, 2/5 studies reviewed chronic pain at rest, 4/5 studies examined chronic pain with mobility.
|
Calcitonin significantly reduced acute pain at rest and mobile. There was no difference in chronic pain in patients treated with calcitonin or control groups. |
Calcitonin has proven value in treating acute back pain associated with recent osteoporotic vertebral compression fractures. Still, there is no evidence to support the use of calcitonin for chronic pain associated with older fractures. |