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Bone density changes before and after administration of danozoomab

Evaluation of bone density changes before and after administration of at least one year of danozoomab in patients referred to Imam Reza Hospital

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210803052067N1
Enrollment
202
Registered
2021-09-21
Start date
2020-07-20
Completion date
Unknown
Last updated
2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis. Osteoporosis with current pathological fracture

Interventions

Intervention group: After performing a bone density test and assuring osteoporosis, the person will receive a 60 mg dose of denosumab(Xgeva®, produced by Amgen ) subcutaneously at baseline and 6 month

Sponsors

Artesh University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
45 Years to 75 Years

Inclusion criteria

Inclusion criteria: Postmenopausal women (aged 45 to 75 years old) diagnosed with osteoporosis by densitometry via Dexa(dual energy Xray absorptiometry).

Exclusion criteria

Exclusion criteria: Lack of consent for being in the trial Having hypersensitivity to denosumab or any component in the formulation Malabsorption syndrome History of thyroid surgery, parathyroid surgery or intestinal resection which has been caused malabsorption Patient

Design outcomes

Primary

MeasureTime frame
Percentage change in Bone mineral density(BMD) at the lumbar spine (L1-L4), femoral neck, and total hip. Timepoint: Baseline and at 12th month of the study. Method of measurement: BMD by dual-energy x-ray absorptiometry Hologic 4500 or higher.

Secondary

MeasureTime frame
(T score). Timepoint: At the beginning of the study and12 months later. Method of measurement: Bone densitometry.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mohsen Ghasemzadeh Soroush

Artesh University of Medical Sciences

mohsensoroosh@gmail.com+98 21 8802 8350

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026