Trial reportOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2014
Efficacy and safety of oral recombinant calcitonin tablets in postmenopausal women with low bone mass and increased fracture risk: a randomized, placebo-controlled trial.
Trial report in Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 35 citations in OpenAlex.
- Clinical Efficacy and Safety of Zoledronic Acid Combined with PVP/PKP in the Treatment of Osteoporotic Vertebral Compression Fracture: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.BioMed research international · 2021Pooled it
- Does salmon calcitonin cause cancer? A review and meta-analysis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2016Pooled it
- The Effects of Osteoporotic and Non-osteoporotic Medications on Fracture Risk and Bone Mineral Density.Drugs · 2021Review
- Effect of Systemic Calcitonin Delivery with and Without Adjunct Local Platelet-rich Fibrin Therapy on Osseointegration in Ovariectomized Osteoporotic Rabbits: A Scanning Electron Microscopy-based Study.Oral health & preventive dentistry · 2021Article
- Special Considerations to Improve Clinical Outcomes in Patients with Osteoporosis Undergoing Spine Surgery.International journal of spine surgery · 2021Article
- Pharmacologic intervention for prevention of fractures in osteopenic and osteoporotic postmenopausal women: Systemic review and meta-analysis.Bone reports · 2020Article
- Calcitonin: A useful old friend.Journal of musculoskeletal & neuronal interactions · 2020Review
- Oral administration of bovine lactoferrin accelerates the healing of fracture in ovariectomized rats.Journal of bone and mineral metabolism · 2020Article
- Protective effect of Glycyrrhiza glabra roots extract on bone mineral density of ovariectomized rats.BioMedicine · 2019Article
- ACTUALITIES IN ENDOCRINE PHARMACOLOGY: ADVANCES IN THE DEVELOPMENT OF ORAL FORMULATIONS FOR CALCITONIN AND SEMAGLUTIDE.Acta endocrinologica (Bucharest, Romania : 2005)Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
unlabelledThe effect of an investigational oral calcitonin tablet upon bone mineral density (BMD) of the spine was investigated in postmenopausal women with low bone mass and at increased risk of fracture. Compared to placebo, calcitonin tablets increased lumbar spine BMD. This agent may provide an additional choice for patients.
introductionAn investigational oral salmon calcitonin preparation was previously shown to increase lumbar spine BMD in postmenopausal women with osteoporosis. Our objective was to evaluate the use of this agent in postmenopausal women with low bone mass and at increased fracture risk but not meeting BMD criteria for osteoporosis.
methodsTreatment-naïve women were randomized to receive oral recombinant salmon calcitonin tablets or placebo once daily for 1 year. Dual-energy X-ray absorptiometry was performed at baseline and at study weeks 28 and 54. CTx-1, a bone resorption marker, was obtained at the same time points. Subjects returned periodically for tolerability assessment and adverse event (AE) recording.
resultsOne hundred twenty-nine women in the USA were randomized, 86 to calcitonin and 43 to placebo. Calcitonin recipients experienced a significant increase from baseline in lumbar spine BMD; the difference compared with placebo was significant. Dosing at bedtime or with dinner was equally effective. CTx-1 was suppressed in calcitonin recipients but not in placebo subjects. Gastrointestinal AEs were common, but the overall safety profile was comparable between groups.
conclusionsOral calcitonin may provide a useful therapeutic alternative for some women with low bone mass.
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