Antiosteoporotik İlaçlarla Magnezyum Etkisi

Sade dilde özet

Bu çalışma, postmenopozal osteoporoz (postmenopausal osteoporosis) nedeniyle enjeksiyon yoluyla bisfosfonat tedavisine başlanan kadınlarda, magnezyum takviyesinin etkisini incelemektedir. Çalışmaya, kırıklı veya kırıksız postmenopozal osteoporozu olan, 50 yaş ve üzeri kadın hastalar alınmıştır. Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 2 (Phase 2)

Durum

Tamamlandı

Sponsor

University Hospital, Clermont-Ferrand

Müdahale

Follow-up of patients with postmenopausal osteoporosis, with or without fractures, requiring initiation of injectable bisphosphonate therapy as part of their usual care, Follow-up of patients with postmenopausal osteoporosis, fractured or not, requiring initiation of injectable bisphosphonate therapy as part of care with magnesium supplementation

Başlangıç

28.06.2022

Tahmini bitiş

19.12.2024

Ülkeler

France

İlgili genler

Merkezler

• Clermont-Ferrand, France

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

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.