Effects of the Combination of Magnesium Bisphosphonates Versus Bisphosphonates Alone on Bone Remodeling: Randomized Pilot Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- C-terminal telopeptides of collagen type 1 (CTX) dosage
研究概览
简要总结
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.
详细描述
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. Category 1.
The primary objective of this randomized trial is to demonstrate the superiority of the combination of bisphosphonates and magnesium over bisphosphonates alone in postmenopausal osteoporosis, in terms of slowing bone remodeling, as assessed by the measurement of C-terminal telopeptides of type 1 bone collagen (CTX).
The secondary objectives are to study the impact of magnesium supplementation at 1 year on:
- the evolution of other biological markers of bone remodeling (by creating a collection of biological samples) and bone densitometry on the following sites: spine, femoral neck, total femur,
- the evolution of cardiovascular parameters,
- the follow-up of the incidence of fractures,
- the evolution of sarcopenia,
- the evolution of quality of life and pain,
- the genetic predisposition of osteoporosis including the confirmation of known genetic markers and the potential identification of new genetic variants involved (by creating a biobank),
- the epigenetic biomarkers in the osteoporosis patient population (by creating a biobank),
- the role of the microbiota in osteoporosis patients (by creating a biobank),
- the occurrence of adverse events.
As part of their usual care and management, patients will be diagnosed with osteoporosis and prescribed bisphosphonates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Bisphosphonates (zoledronic acid, Aclasta® 5 mg) alone
Bisphosphonates are considered as the gold standard of treatment for osteoporosis. Zoledronic acid, Aclasta® 5 mg will be administered intravenously according to standard management criteria in order to obtain an homogeneous population.
干预措施: Follow-up of patients with postmenopausal osteoporosis, with or without fractures, requiring initiation of injectable bisphosphonate therapy as part of their usual care (Other)
bisphosphonates (zoledronic acid, Aclasta® 5 mg) associated with magnesium (MAG 2®, 100 mg)
In addition to bisphosphonates, patients in this group will take a 3-month treatment of magnesium (magnesium carbonate, MAG 2® 100 mg), 2 tablets of 100 mg/day, during the 3 months preceding the 1-year visit.
干预措施: Follow-up of patients with postmenopausal osteoporosis, fractured or not, requiring initiation of injectable bisphosphonate therapy as part of care with magnesium supplementation (Drug)
结局指标
主要结局
C-terminal telopeptides of collagen type 1 (CTX) dosage
时间窗: Visit 3: Day 0+1 year
Evaluation of the CTX evolution after one year, defined as the difference \[after - before\], relative to the basal value (ng/ml). For this purpose, a blood sample will be taken using 5 mL dry tubes.
次要结局
- N-terminal propeptide of procollagen type 1 (P1NP) dosage(Visit 3: Day 0+1 year)
- Osteocalcin dosage(Visit 3: Day 0+1 year)
- Sclerostin dosage(Visit 3: Day 0+1 year)
- Periostin dosage(Visit 3: Day 0+1 year)
- Irisin dosage(Visit 3: Day 0+1 year)
- Dickkopf-related protein 1 (DKK1) dosage(Visit 3: Day 0+1 year)
- Magnesium (Mg) dosage(Visit 3: Day 0+1 year)
- Evaluation of bone densitometric parameters (femoral neck)(Visit 3: Day 0+1 year)
- Evaluation of bone densitometric parameters (total femur)(Visit 3: Day 0+1 year)
- Evaluation of bone densitometric parameters (spine)(Visit 3: Day 0+1 year)
- Endothelial dysfunction measured by FMD (Flow-Mediated Dilation)(Visit 3: Day 0+1 year)
- Evaluation of the muscular strength(Visit 3: Day 0+1 year)
- Measurement of digital volume increase by RHI (Reactive Hyperhemia Index), (Endo-PAT2000; Itamar Medical Ltd, Israel).(Visit 3: Day 0+1 year)
- Microcirculation measurement by FLD (Flow Laser Doppler), PeriFlux® (Perimed)(Visit 3: Day 0+1 year)
- Sphygmocor CPV® (Atcor Medical) large artery stiffness measurement (PWV)(Visit 3: Day 0+1 year)
- Evaluation of the Abdominal Aorta Calcification (AAC) (Kauppila score)(Visit 3: Day 0+1 year)
- Strength, Assistance with walking, Rising from a chair, Climbing stairs, and Falls (SARC-F) questionnaire(Visit 3: Day 0+1 year)
- Short Physical Performance Battery (SPPB) Questionnaire(Visit 3: Day 0+1 year)
- Body composition measurement on Dual energy X-ray Absorptiometry (DXA)(Visit 3: Day 0+1 year)
- The Brief Pain Inventory Questionnaire (BPI)(Visit 3: Day 0+1 year)
- The Numerical Pain Scale(Visit 3: Day 0+1 year)
- Measurement of the threshold of sensitivity and pain perception induced by a thermal stimulus (hot and cold) at the Pathway - Médoc®.(Visit 3: Day 0+1 year)
- Central sensitization tests, measurement of the Conditioned Pain Modulation (CPM) effect(Visit 3: Day 0+1 year)
- The Pittsburgh Sleep Quality Index (PSQI)(Visit 3: Day 0+1 year)
- The 36-Item Short Form Survey (SF-36)(Visit 3: Day 0+1 year)
- Distribution of gene polymorphisms using OpenArray technology(Visit 1: Day 0)
- MicroRNA analysis using OpenArray technology will be performed on 48 patients(Visit 3: Day 0+1 year)
- The Hospital Anxiety and Depression Scale (HAD)(Visit 3: Day 0+1 year)
- Study of the microbiota will be performed on 48 patients(Visit 3: Day 0+1 year)