Yükleniyor... / Loading...
This study examines the effect of magnesium supplementation in women who are starting injectable bisphosphonate therapy for postmenopausal osteoporosis. It enrolled women aged 50 and over with postmenopausal osteoporosis, with or without fractures. The study was conducted in Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Women aged 50 years or older, with postmenopausal osteoporosis, fractured or not, requiring initiation of injectable bisphosphonate therapy as part of their care. * Able to give informed consent to participate in the research. * Affiliation to a Social Security system. Exclusion Criteria: * Initial densitometry more than one year old. * Patient receiving a treatment or food supplement containing magnesium (Mg). * Contra-indication to the administration of Mg: hypersensitivity to magnesium carbonate or to one of the excipients. * Patients with a magnesium level \> 1.07 mmol/l. * Patient with chronic renal failure, defined as creatinine clearance \< 35 mL/min estimated by Cockcroft-Gault or glomerular filtration rate \< 30 mL.min-1 estimated by CKD-EPI and taking into account which is more pejorative. * Patient with a medical and/or surgical history deemed by the investigator or his representative to be incompatible with the trial. * Patient under legal protection or deprived of liberty. * Refusal to participate.