NCT05328154CompletedPhase 2
MAGnesium Effect With ANtiosteoporotic Drugs
Effects of the Combination of Magnesium Bisphosphonates Versus Bisphosphonates Alone on Bone Remodeling: Randomized Pilot Clinical Trial
Source: ClinicalTrials.gov · Last updated 27 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 45 (actual)
- First submitted
- 29 Mar 2022
- Start date
- 28 Jun 2022
- Primary completion date
- 19 Dec 2024
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Diseases
- Osteoporosis
- NCT number
- NCT05328154
- EudraCT number
- 2021-005401-28
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 45
- From 28 Jun 2022 to the primary completion date, 19 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient with a medical and/or surgical history deemed by the investigator or his representative to be incompatible with the trial.
Lab values
- 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.
Other
- Initial densitometry more than one year old.
- Patient under legal protection or deprived of liberty.
- Refusal to participate.
Who the study is looking for
- 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.
Age in the registry: 50 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
Related publications
- Quantitative sensory testing of pain in osteoporosis: a pilot randomized clinical trial with magnesium supplementation.Aging Clin Exp Res · 2026 · PMID 41566091
This page is information, not medical advice. Discuss any trial with your doctor.