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 range

50 Years

Sex

FEMALE

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

C-terminal telopeptides of collagen type 1 (CTX) dosage

Timeframe: Visit 0: Day 0-1 month

C-terminal telopeptides of collagen type 1 (CTX) dosage

Timeframe: Visit 3: Day 0+1 year

Trial details

NCT IDNCT05328154

SponsorUniversity Hospital, Clermont-Ferrand

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-19

View on ClinicalTrials.gov More Osteoporosis, Postmenopausal trials