Clinical trial
Effects of the Combination of Magnesium Bisphosphonates Versus Bisphosphonates Alone on Bone Remodeling: Randomized Pilot Clinical Trial
Name
AOI 2021 ME_PICKERING
Description
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.
Trial arms
Trial start
2022-06-28
Estimated PCD
2024-12-31
Trial end
2024-12-31
Status
Recruiting
Phase
Early phase I
Treatment
Follow-up of patients with postmenopausal osteoporosis, with or without fractures, requiring initiation of injectable bisphosphonate therapy as part of their usual care
* Inclusion medical consultation
* Inclusion clinical examination
* Calculation of Kauppila score at one year
* Imaging procedures (DXA) at 1 year
* Magnesium dosage: Visit 1: Day 0 and Visit 3: Day 0+1 year
* Samples for biological collection and microbiota analysis Visit 1: Day 0 and Visit 3: Day 0+1 year
* Genotyping in Visit 1: Day 0
* Serum CTX dosage in Visit 3: Day 0+1 year
* Cardiovascular investigations (FMD, RHI, FLD, PWV) in Visit 1: Day 0 and Visit 3: Day 0+1 year
* Exploration of sarcopenia (SARC-F, SPPB, muscle strength and body composition) in Visit 1: Day 0 and Visit 3: Day 0+1 year
* Exploration of pain (NPS, BPI, sensitivity/pain thresholds, CPM) in Visit 1: Day 0 and Visit 3: Day 0+1 year
* Quality of life component questionnaires (PSQI, HADs, SF-36) in Visit 1: Day 0 and Visit 3: Day 0+1 year
* Follow-up diary to be completed at months 1 and 12 of the study
Arms:
Bisphosphonates (zoledronic acid, Aclasta® 5 mg) alone
Follow-up of patients with postmenopausal osteoporosis, fractured or not, requiring initiation of injectable bisphosphonate therapy as part of care with magnesium supplementation
* Inclusion medical consultation
* Inclusion clinical examination
* Calculation of Kauppila score at one year
* Imaging procedures (DXA) at 1 year
* Magnesium dosage: Visit 1: Day 0; Visit 2: Day 0+9 months and Visit 3: Day 0+1 year
* Samples for biological collection and microbiota analysis Visit 1: Day 0 and Visit 3: Day 0+1 year
* Genotyping in Visit 1: Day 0
* Serum CTX dosage in Visit 3: Day 0+1 year
* Cardiovascular investigations (FMD, RHI, FLD, PWV) in Visit 1: Day 0 and Visit 3: Day 0+1 year
* Exploration of sarcopenia (SARC-F, SPPB, muscle strength and body composition) in Visit 1: Day 0 and Visit 3: Day 0+1 year
* Exploration of pain (NPS, BPI, sensitivity/pain thresholds, CPM) in Visit 1: Day 0 and Visit 3: Day 0+1 year
* Quality of life component questionnaires (PSQI, HADs, SF-36) in Visit 1: Day 0 and Visit 3: Day 0+1 year
* Magnesium intake for 1 period of 3 months
* Phone call
* Follow-up diary to be completed at months 1, 10, 11 and 12 of the study
Arms:
bisphosphonates (zoledronic acid, Aclasta® 5 mg) associated with magnesium (MAG 2®, 100 mg)
Size
48
Primary endpoint
C-terminal telopeptides of collagen type 1 (CTX) dosage
Visit 0: Day 0-1 month
C-terminal telopeptides of collagen type 1 (CTX) dosage
Visit 3: Day 0+1 year
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Following the inclusion visit, patients will be assigned to one of the two groups (bisphosphonates alone or bisphosphonate associated with magnesium). Treatment assignment will follow a predefined randomization list and will be performed by a Clinical Research Associate who is totally independent from the protocol. The randomization list and a copy will be edited and given to the Clermont-Ferrand University Hospital Pharmacy and to the Rheumatology Department of the Gabriel Montpied University Hospital.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 48, 'type': 'ESTIMATED'}}
Updated at
2023-06-18
1 organization
1 product
2 indications
Organization
University Hospital Clermont-FerrandIndication
OsteoporosisIndication
Postmenopausal