Romosozumab
Treatment for Osteoporosis
Typical Dosage: 210 mg subcutaneous injection once monthly
Effectiveness
75%
Safety Score
55%
Clinical Trials
30
Participants
12K
Comparative Safety Scale(Higher is safer)
Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
55
DangerousModerateSafe
Treatment Details
Dosage Range
210 mg subcutaneous injection once monthly
Time to Effect
3-6 months
Treatment Duration
12 months (followed by anti-resorptive)
Evidence Quality
HIGHNumber Needed to Treat (NNT)
10(Treat 10 patients to see 1 additional successful outcome)
Number Needed to Harm (NNH)
200(Treat 200 patients to see 1 additional serious adverse event)
Confidence Score
85%confidence in effectiveness data
Health Economics
Annual Cost of Care
Drug Cost:$27,000
Monitoring:$500
Side Effect Mgmt:$200
Total Annual:$27,700
Cost-Effectiveness Analysis
Cost-Effectiveness Rating
POORICER
$250,000/QALY
QALYs Gained
0.3
Romosozumab Outcomes
for Osteoporosis
Efficacy Outcomes
Overall Effectiveness
+75%
Common Side Effects
Arthralgia
+14%
Headache
+10%
Injection site reactions
+7%
Myocardial infarction
+0.8%
Stroke
+0.8%
Osteonecrosis of the jaw (ONJ)
+0.05%
Atypical femoral fracture (AFF)
+0.01%
Sources:
Active Clinical Trials
9 active trials recruiting for Romosozumab in Osteoporosis
The Optimised Use of Romozosumab Study
NCT06059222RECRUITINGPHASE4
270 participants
INTERVENTIONAL
Aarhus, Denmark
Started: Oct 2, 2023
Romosozumab and Denosumab, Alone or Combined, in Postmenopausal Osteoporosis
NCT07283887RECRUITINGPHASE4
90 participants
INTERVENTIONAL
Douliu, Taiwan
Started: Dec 3, 2025
A Study of Romosozumab in Women With Multiple Myeloma and Osteoporosis
NCT05775094ACTIVE NOT RECRUITINGPHASE1
10 participants
INTERVENTIONAL
Basking Ridge, United States +6 more
Started: Mar 7, 2023
Combined Anabolic Therapy
NCT06558188RECRUITINGPHASE4
50 participants
INTERVENTIONAL
Boston, United States
Started: Feb 3, 2025
Effects of Cycle Therapy vs Sequential Therapy With Romosozumab and Denosumab in Postmenopausal Osteoporosis Patients
NCT06938152RECRUITINGPHASE4
70 participants
INTERVENTIONAL
Taipei, Taiwan
Started: Apr 8, 2025
Romosozumab Versus Denosumab in GIOP: a 2-year Extension Study
NCT06472050RECRUITINGPHASE4
63 participants
INTERVENTIONAL
Hong Kong, China
Started: Aug 20, 2024
Anabolic Therapy in Postmenopausal Osteoporosis
NCT05010590ACTIVE NOT RECRUITINGPHASE4
50 participants
INTERVENTIONAL
Boston, United States
Started: Mar 24, 2022
Romosozumab Effects on Bone Density, Muscle Mass, and Spine Surgery Outcomes
NCT06973109NOT YET RECRUITINGPHASE2
36 participants
INTERVENTIONAL
Pittsburgh, United States
Started: Jan 26, 2026
Treatment With Romosozumab Versus Denosumab to Improve Bone Mineral Density and Architecture in Subacute SCI
NCT05101018ACTIVE NOT RECRUITINGPHASE4
40 participants
INTERVENTIONAL
West Orange, United States +1 more
Started: Nov 1, 2021
Completed Clinical Trials
11 completed trials for Romosozumab in Osteoporosis
Transition From Alendronate to Romosozumab (AMG 785)
NCT01588509COMPLETEDPHASE1
60 participants
INTERVENTIONAL
Tucson, United States +8 more
Started: Mar 30, 2012
A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India With Osteoporosis at a High Risk of Fracture.
NCT06079476COMPLETEDPHASE4
100 participants
INTERVENTIONAL
Ahmedabad, India +9 more
Started: Oct 30, 2023
Study of Romosozumab (AMG 785) Administered to Healthy Participants and Patients With Stage 4 Renal Impairment or Stage 5 Renal Impairment Requiring Hemodialysis
NCT01833754COMPLETEDPHASE1
24 participants
INTERVENTIONAL
Tempe, United States +4 more
Started: Apr 22, 2013
A Study to Test the Efficacy, Safety and Tolerability of Romosozumab Treatment in Postmenopausal Chinese Women With Osteoporosis
NCT05067335COMPLETEDPHASE3
327 participants
INTERVENTIONAL
Beijing, China +29 more
Started: Oct 21, 2021
Romosozumab Versus Denosumab for Osteoporosis in Long-term Glucocorticoid Users
NCT04091243COMPLETEDPHASE4
70 participants
INTERVENTIONAL
Hong Kong, China
Started: Jan 15, 2021
A Safety and Efficacy Study to Evaluate Romosozumab (AMG 785) in South Korean Women With Osteoporosis
NCT02791516COMPLETEDPHASE3
67 participants
INTERVENTIONAL
Busan, South Korea +9 more
Started: Jan 16, 2017
A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis
NCT02186171COMPLETEDPHASE3
245 participants
INTERVENTIONAL
Lakewood, United States +33 more
Started: Jun 16, 2014
Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis
NCT01992159COMPLETEDPHASE2
252 participants
INTERVENTIONAL
Anjyo-shi, Japan +26 more
Started: Oct 12, 2012
Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis
NCT01575834COMPLETEDPHASE3
7.18K participants
INTERVENTIONAL
Tucson, United States +217 more
Started: Mar 15, 2012
A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis
NCT03432533COMPLETEDPHASE3
283 participants
INTERVENTIONAL
Birmingham, United States +45 more
Started: Feb 6, 2018
Romosozumab in Women With Chronic SCI
NCT04708886COMPLETEDPHASE2
12 participants
INTERVENTIONAL
Chicago, United States
Started: Mar 1, 2021
Showing 20 of 31 total trials