NCT03293108 - Comparing Efficacy and Safety of AryoGen Pharmed Biosimilar Denosumab 60 mg (Arylia) Versus Prolia® in Improvement of Bone Mineral Densitometry (BMD) Among Osteoporotic Postmenopausal Women | Biotech Hunter

Enrollment

190

Participants

Timeline

Start Date

April 29, 2017

Primary Completion Date

September 30, 2020

Study Completion Date

September 30, 2020

Conditions

Osteoporosis

Interventions

DRUG

Denosumab

Denosumab 60 mg is subcutaneously administered to osteoporotic patients at baseline, month 6 and month 12.

DIETARY_SUPPLEMENT

calcium

All women will receive daily supplements containing at least 1000 mg of elemental calcium (divided in two doses), during 18 month of the study.

DIETARY_SUPPLEMENT

vitamin D

All women will receive daily supplements containing at least 400 IU vitamin D daily during 18 month of the study.

Trial Locations (1)

Rheumatology Center of Iran, Tehran