MAGnesium Effect With ANtiosteoporotic Drugs (NCT05328154) | Clinical Trial Compass
CompletedPhase 2
MAGnesium Effect With ANtiosteoporotic Drugs
France45 participantsStarted 2022-06-28
Plain-language summary
Randomized pilot clinical trial to demonstrate superiority of bisphosphonate-magnesium combination over bisphosphonates alone in postmenopausal osteoporosis in slowing bone remodeling as assessed by C-terminal telopeptide of bone collagen type 1 (CTX) dosage.
Who can participate
Age range50 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
C-terminal telopeptides of collagen type 1 (CTX) dosage
Timeframe: Visit 0: Day 0-1 month
2
C-terminal telopeptides of collagen type 1 (CTX) dosage