A Phase 3 interventional study of Denosumab and calcium in Osteoporosis, sponsored by AryoGen Pharmed Co.. Status unknown at 1 site in Iran, Islamic Republic of. Open to female participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-07-10.
Sponsored by AryoGen Pharmed Co. · Phase 3, Interventional, and Treatment
The purpose of this study is to compare the efficacy and safety of Denosumab 60 mg produced by AryoGen Pharmed and Amgen Denosumab 60 mg among osteoporotic postmenopausal women. Postmenopausal women diagnosed with osteoporosis according to their Bone mineral density result (BMD), aged between 45 to 75 are included in this trial. This is a Phase III, randomized, two armed, double-blind, parallel, active-controlled,non-inferiority clinical trial. The eligible patients are randomized in a 1:1 ratio to receive Arylia or Prolia® subcutaneous injections, at the beginning of the trial and every 6 months at month 6 and 12, in an 18-month study period. Along with, all women will receive daily supplements containing at least 1000 mg of elemental calcium (divided into two doses) and at least 400 IU vitamin D daily during 18 months of the study.
The primary objective of this study is to assess non-inferiority of test- Denosumab 60 mg (Arylia) to the reference Denosumab 60 mg (Prolia®) in terms of efficacy among osteoporotic postmenopausal women.
The secondary objectives of this study are:
To further compare efficacy of test- Denosumab 60 mg to reference Denosumab 60 mg; To assess the safety of test- Denosumab 60 mg compared to reference Denosumab 60 mg.
The purpose of this study is to compare the efficacy and safety of Denosumab 60 mg produced by AryoGen Pharmed and Amgen Denosumab 60 mg among osteoporotic postmenopausal women. Postmenopausal women diagnosed with osteoporosis according to their Bone mineral density result (BMD) and aged between 45 to 75 are included in this trial. This is a Phase III, randomized, two armed, double-blind, parallel, active-controlled,non-inferiority clinical trial. Visits are going to be conducted at screening, 0, 1, 3, 6, 9, 12, 15 and 18 months.
After signing the written informed consent, patients are randomized in a 1:1 ratio to receive Arylia or Prolia® subcutaneous injections, at the beginning of the trial and every 6 months at month 6 and 12, in an 18-month study period. Along with, all women will receive daily supplements containing at least 1000 mg of elemental calcium (divided into two doses) and at least 400 IU vitamin D daily during 18 months of the study.
The primary objective of this study is to assess percentage change from baseline in BMD at the lumbar spine (L1-L4), femoral neck and total hip by dual-energy x-ray absorptiometry to 18 months of the study, and compare it between two treatment groups.
The second objectives of this study are to assess the followings between treatment groups:
Before initiation, the trial is reviewed by food and drug administration of Iran. The protocol, electronic case report form (eCRF), information for patients and informed consent forms are submitted to the ethics committees responsible for review and approval purposes, according to national regulatory guidelines.
Sample size:
172 patients will be equally (1:1) divided into intervention arms for achieving 80% power in order to determine non-inferiority using a one-sided, independent sample t-test. Efficacy of Prolia® in comparison with placebo for lumbar spine BMD improvement in previous studies is reported 7.1%. The margin of non-inferiority is 1.78. The true difference between the means is assumed to be 0.000. The significance level (alpha) of the test is 0.025. The data are drawn from populations with standard deviations of 4.116 and 4.116. However, we have calculated that 190 patients should enter the study, by considering that there might be 10% drop-outs of participants during the trial.
Blinding:
To prevent the influence of knowing intervention group on study conclusion, the subjects and those who assess the study outcomes will be unaware of the state of the patient with regard to receiving the test drug or reference drug.
For this purpose, subjects and administrator of the drug will be blinded by using a similar masked prefilled syringes. All drugs packages will be identified by unique numbers.
Exclusion Criteria:
Arylia (Denosumab Prefilled Syringe produced by AryoGen Pharmed) 60 mg/1 ml in a prefilled syringe. Denosumab 60 mg is subcutaneously administered to osteoporotic patients at baseline, month 6 and month 12. Along with, all women will receive daily supplements containing at least 1000 mg of elemental calcium (divided into two doses) and at least 400 IU vitamin D daily during 18 months of the study.
Drug: Denosumab · Dietary Supplement: calcium · Dietary Supplement: vitamin D
Prolia® (Denosumab Prefilled Syringe produced by Amgen) 60 mg/1 ml in a prefilled syringe. Denosumab 60 mg is subcutaneously administered to osteoporotic patients at baseline, month 6 and month 12. Along with, all women will receive daily supplements containing at least 1000 mg of elemental calcium (divided into two doses) and at least 400 IU vitamin D daily during 18 months of the study.
Drug: Denosumab · Dietary Supplement: calcium · Dietary Supplement: vitamin D
Denosumab 60 mg is subcutaneously administered to osteoporotic patients at baseline, month 6 and month 12.
All women will receive daily supplements containing at least 1000 mg of elemental calcium (divided in two doses), during 18 month of the study.
All women will receive daily supplements containing at least 400 IU vitamin D daily during 18 month of the study.
BMD percentage change from baseline at lumbar spine (L1-L4), femoral neck and total hip.
Percentage change from baseline in BMD at lumbar spine (L1-L4), femoral neck and total hip by dual-energy x-ray absorptiometry to 18 months of the study, and compare between two groups.
Time frame: Baseline and at 18 months.
The incidence of new vertebral fracture.
The incidence of new vertebral fracture assessed by Lateral spine X-ray radiography (T4-L4) at baseline then at 18 months, and compare between two groups.
Time frame: Baseline and at 18 months
Evolution of biochemical markers of bone metabolism.
Evolution of biochemical markers of bone metabolism at baseline, first month and afterwards every 3 months from baseline, and compare between two groups.
Time frame: Baseline,at month 1,at month 3,at month 6,at month 9, at month 12, at month 15 and at month 18.
Comparing adverse events between two products.
Evaluation of the following parameters at each visit including 0, 1, 3, 6, 9, 12, 15 and 18 months, and compare between two groups. * Adverse events (AEs), Adverse drug reactions (ADR) * Changes in physical examination findings * Changes in vital signs * Clinical laboratory testing for systemic safety, including liver function, renal function, complete blood count, and clinical chemistries.
Time frame: baseline,at month 1,at month 3,at month 6,at month 9,at month 12, at month 15 and at month 18.
Comparing immunogenicity between two products.
Evaluation of immunogenicity at visit 0, 6, 12 and 18 months for both arms, and compare between two groups.
Time frame: Baseline,at month 6,at month 12 and at month 18.
Plan to share: No
This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
AryoGen Pharmed Co.