Trial reportAging clinical and experimental research2026
Quantitative sensory testing of pain in osteoporosis: a pilot randomized clinical trial with magnesium supplementation.
Trial report in Aging clinical and experimental research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05328154 (Effects of the Combination of Magnesium Bisphosphonates Versus Bisphosphonates Alone on Bone Remodeling), which is not on this map. Not yet cited in PubMed.
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Effects of the Combination of Magnesium Bisphosphonates Versus Bisphosphonates Alone on Bone Remodeling: Randomized Pilot Clinical Trial
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundBisphosphonates (BP) are a recommended treatment for osteoporosis and an analgesic effect has been suggested. Magnesium is involved in pain mechanisms, mood disorders and also in bone homeostasis. Association of BPs and magnesium has however not been studied to explore pain processes in post-menopausal osteoporosis.
methodsIn this pilot ancillary study of a randomized clinical trial in post-menopausal osteoporosis, women were randomized to standard care with intravenous Zoledronate (BP group, n = 22) or BP with oral magnesium (BPMg group, n = 22), 200 mg/day for 3 months. Endpoints were quantified before and 1 year after treatment as spontaneous pain, anxiety, depression and sleep quality, as well as quantitative sensory testing of pain sensitivity by thermal thresholds and conditioned pain modulation (CPM), a psychophysical marker of the functionality of pain modulation at spinal level.
resultsThirty-five women (68.2 ± 7.3 years old) with post-menopausal osteoporosis completed the analysis. Compared with baseline, magnesium supplementation did not change significantly any of the endpoints. CPM at baseline was low (-0.92 ± 1.14) and not reversed by treatment.
conclusionsThis study in post-menopausal osteoporosis underlines for the first time that zoledronate or zoledronate with magnesium have no effect on pain characteristics and thresholds. It shows a dysfunction of pain inhibitory pain pathways and its non-reversibility with treatments. It points towards the lack of any analgesic effect of zoledronate, and above all to a latent vulnerability of osteoporotic women who are at a potential risk of fracture with a poor pain modulation that needs to be researched further to limit future chronification. TRIAL REGISTRATION NUMBER: (NCT05328154), 15/03/2022. TRIAL: Protocol, statistical analysis plan, participant data and other materials (including data dictionary) can be accessed on request to the corresponding author.
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