Osteoporosis. Age-related osteoporosis without current pathological fracture
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Confirmed menopause (more than 12 months of amenorrhea) Osteoporosis diagnosis based on Dual-Energy X-ray Absorptiometry scan as (T-score=-2.5 at L1-L4 or femoral neck)
Exclusion criteria
Exclusion criteria: Moderate/severe renal impairment (Glomerular filtration rate < 30–35 ml/min/1.73m2) History of hypersensitivity to the study drugs Secondary diseases affecting bone metabolism (active hyperparathyroidism, multiple myeloma, active hyperthyroidism)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone density. Timepoint: At the beginning of the study (before the start of the intervention) and 24 months after initiation of treatment (6 months in the Denosumab group and 12 months in the Zoledronic acid group after completion of the intervention). Method of measurement: Dual-energy X-ray absorptiometry scan.;Adverse effects of Denosumab and Zoledronic acid. Timepoint: Recording of adverse effects at 6, 12, 18, and 24 months after initiation of treatment. Method of measurement: Clinical examination. | — |
Countries
Iran (Islamic Republic of)
Contacts
Islamic Azad University