Abstract
BackgroundBone microarchitecture is a significant determinant of bone strength. So far, the assessment of bone microarchitecture has required bone biopsies, limiting its utilization in clinical practice to one single skeletal site. With the advance of high-resolution imaging techniques, non-invasive in vivo measurement of bone microarchitecture has recently become possible. This provides an opportunity to efficiently assess the effects of anti-osteoporotic therapies on bone microarchitecture. We therefore designed a protocol to investigate the effects of nasal salmon calcitonin, an inhibitor of osteoclast activity, on bone microarchitecture in postmenopausal women, comparing weight bearing and non-weight bearing skeletal sites.MethodsOne hundred postmenopausal women will be included in a randomized, placebo-controlled, double-blind trial comparing the effect of nasal salmon calcitonin (200 UI/day) to placebo over two years. Bone microarchitecture at the distal radius and distal tibia will be determined yearly by high-resolution peripheral quantitative computerized tomography (p-QCT) with a voxel size of 82 μm and an irradiation of less than 5 μSv. Serum markers of bone resorption and bone formation will be measured every 6 months. Safety and compliance will be assessed. Primary endpoint is the change in bone microarchitecture; secondary endpoint is the change in markers of bone turnover.HypothesisThe present study should provide new information on the mode of action of nasal calcitonin. We hypothezise that - compared to placebo - calcitonin impacts on microstructural parameters, with a possible difference between weight bearing and non-weight bearing bones.Trial RegistrationClinicalTrials.gov NCT00372099
Highlights
Bone microarchitecture is a significant determinant of bone strength
Osteoporosis is characterized by compromised bone strength and higher fragility, resulting in an increased fracture risk [1]
Bone strength is determined by bone geometry, bone microarchitecture, bone remodelling and intrinsic tissue quality [2]
Summary
Study design This is a monocentric, randomized, placebo-controlled, double-blind trial over two years, assessing the effects of nasal calcitonin (200 IU/day) on bone microarchitecture measured by high resolution p-QCT in postmenopausal women. This protocol was initiated by the principal investigator and has been accepted by the ethics committee of the University Hospitals of Geneva and by the Swiss legislative authority (Swissmedic). To assess the treatment effects of calcitonin on bone microarchitecture and provide a proof of concept, the primary analysis of the efficacy endpoints in this exploratory trial will be based on the observed data of the per-protocol population. Any other information collected (e.g. severity or relatedness to study medication) will be listed as appropriate
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