Status:
COMPLETED
MAGnesium Effect With ANtiosteoporotic Drugs
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Osteoporosis, Postmenopausal
Eligibility:
FEMALE
50+ years
Phase:
PHASE2
Brief 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...
Detailed Description
A pilot, randomized, controlled, open-label, single-center, two-parallel-arm clinical trial testing the addition of oral magnesium supplementation to prescribed drug therapy in the care setting. Categ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2024
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05328154
Start Date
June 28 2022
End Date
December 19 2024
Last Update
December 27 2024
Active Locations (1)
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1
CHU clermont-ferrand
Clermont-Ferrand, France