Postmenopausal osteoporosis. Postmenopausal osteoporosis
Conditions
Interventions
Intervention 1: Denosumab (produced by AryoGen Pharmed) prefilled syringe for patients with dose of 60 mg, subcutaneous (S/C) injection every 6 months, at the beginning of the trial, month 6 and 12. I
Sponsors
AryoGen Pharmed company
Eligibility
Sex/Gender
Female
Age
45 Years to 75 Years
Inclusion criteria
Inclusion criteria: Postmenopausal women aged between 45 up to 75. Bone mineral density T score at the lumbar spine (L1-L4), femoral neck or total hip should be equal or less than -2.5 and equal or more than -4. (-4 =T score =-2.5); or patients with high risk of fracture on the basis of FRAX criteria which according to osteoporosis treatment guidelines, need medicinal treatment Ability to comprehend and willingness to sign the Informed Consent Form for this study; Signed informed consent with full knowledge and mental health.
Exclusion criteria
Exclusion criteria: Lack of consent for being in the trial and not complying with an 18-months follow-up. Having hypersensitivity to denosumab or any component in the formulation (excipients include acetic acid, sorbitol, Polysorbate 20, sodium hydroxide, water for injections) Malabsorption syndrome History of thyroid surgery, parathyroid surgery or intestinal resection which has been caused malabsorption Patient with CKD stage 4 and 5 should be excluded (GFR 250 mg/24h) and hypocalciuria (5 mg/prednisone daily or equivalent for = 3months), in the past 3 months and more Use of heparin (more than 20,000 international units/day for 6 months and longer), in the past 6 months and more. Patient that is possible to be administrated corticosteroids (>5 mg/prednisone daily or equivalent for = 3months) or heparin (more than 20,000 international units/day for 6 months and longer) in the 18 month of the study, because of her chronic disease(s) such as allergy, asthma, coagulation disorders, should be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in BMD at the lumbar spine (L1-L4), femoral neck, and total hip. Timepoint: Baseline and at 18th month of the study. Method of measurement: BMD by dual-energy x-ray absorptiometry Hologic 4500 or higher. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events ocurrance. Timepoint: all of the visit ( 1-9). Method of measurement: Physical examination, physician Assessment, and laboratory tests.;Level of biochemical markers of bone metabolism (Serum CTX, Serum NTX, P1NP, OC, BSAP). Timepoint: Before injection at visit 2, 3, 4, 5, 6, 7, 8 and 9. Method of measurement: ELISA method.;The incidence of new vertebral fracture. Timepoint: The incidence of new vertebral fracture at baseline and at 18th month of the study. Method of measurement: X-ray radiography.;Immunogenicity of two products. Timepoint: Before the injections, at visit 2, 5, 7 and 9. Method of measurement: ELISA method. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactRamin Azhdarzadeh
Orchid Pharmed company
Outcome results
None listed