MAGnesium Effect With ANtiosteoporotic Drugs

• Status: Not yet recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Clermont-Ferrand
• Treatments: Diphosphonates

Criteria

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.