Oral administration of salmon calcitonin for postmenopausal women with low bone mass

Study Type: Therapy
OE Level of Evidence: 2
Journal Level of Evidence: N/A
Synopsis
129 postmenopausal women with low bone mass were randomly assigned to receive either salmon calcitonin orally or placebo once daily for 1 year. The outcomes of interest were the change in bone mineral density (at the lumbar spine, femoral neck, trochanter, and total hip) and collagen type 1 C-telopeptide (CTx-1). The findings demonstrated Please login to view the rest of this report. Please login to view the rest of this report.
Funding: Industry funded
Sponsor: Tarsa Therapeutics, Inc.
Conflicts: Company Employee
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Why was this study needed now?
As a result of lower peak bone mass and rapid perimenopausal bone loss, women are more susceptible to osteoporosis than men. Calcitonins are naturally-occurring, calcium-regulating peptide hormones and have been suggested to reduce bone loss. Synthetic salmon calcitonin is already on the market in injectable formulas and nasal sprays, but oral preparations may encourage better compliance. A previous study found that oral calcitonin increased bone mineral density to a greater degree than nasal calcitonin in osteoporotic postmenopausal women, but oral administration has still not yet been validated. This trial aimed to evaluate the efficacy of oral calcitonin compared to placebo in postmenopausal women with osteopenia.
What was the principal research question?
In postmenopausal women with osteopenia, does daily oral salmon calcitonin for 1 year lead to significantly increase bone mineral density when compared to placebo?
Population: 129 women over 45 years of age and at least 5 years postmenopause with BMD T-score less than -1.0 but greater than -2.5 were included in this trial.
Intervention: Oral calcitonin: Patients were instructed to take one tablet of 0.2 mg (200 micrograms/1200 IU) salmon calcitonin once daily with the evening meal. Calcium citrate (600 mg) and vitamin D (1000 IU) supplements were also taken daily at breakfast. (N=86, only 69 patients completed final follow-up; Mean age 67.5 +/- 6.9)
Comparison: Placebo: Patients were instructed to take one placebo tablet once daily with the evening meal. Calcium citrate (600 mg) and vitamin D (1000 IU) supplements were also taken daily at breakfast. (N=43, only 30 patients completed final follow-up; Mean age 66.6 +/- 5.2)
Outcomes: Bone mineral density (BMD) was measured at the lumbar spine, femoral neck, trochanter, and total hip via dual energy x-ray absorptiometry (DXA). Bone resorption was assessed using a blood sample for determination of collagen type I C-telopeptide (CTx-1).
Methods: RCT: Multi-center (11 sites across the USA), double-blind (patients & assessors)
Time: Outcomes were assessed at 28 and 54 weeks of intervention.
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The authors responsible for this critical appraisal and ACE Report indicate no potential conflicts of interest relating to the content in the original publication.