Effects of the combination of magnesium bisphosphonates versus bisphosphonates alone on bone remodeling:

Phase 1

• Conditions: postmenopausal osteoporosis; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2021-005401-28-FR
• Lead Sponsor: niversity Hospital of Clermont-Ferrand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-03
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

- Woman aged 50 or over, suffering from postmenopausal osteoporosis, fracture or not, requiring the initiation of treatment with injectable bisphosphonates as part of the care.
- Able to give informed consent to participate in research.
- Affiliation to a French Social Sregimen
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 48

Exclusion Criteria

- Initial densitometry more than a year old.
- Patient receiving a treatment or food supplement containing magnesium.
- Contraindication to the administration of Mg: hypersensitivity to magnesium carbonate or to any of the excipients.
- Patient with magnesium> 1.07 mmol / l,
- Patient with chronic renal failure, defined by a glomerular filtration rate <30 mL.min – 1 estimated by CKD-EPI
- Patient with a medical and / or surgical history judged by the investigator or his representative to be incompatible with the test.
- Patient under legal protection or deprived of liberty.
- Refusal of participation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified