Denosumab
Treatment for Osteoporosis
Typical Dosage: 60 mg subcutaneous injection every 6 months
Effectiveness
70%
Safety Score
60%
Clinical Trials
151
Participants
22K
Comparative Safety Scale(Higher is safer)
Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
60
DangerousModerateSafe
Treatment Details
Dosage Range
60 mg subcutaneous injection every 6 months
Time to Effect
6-12 months
Treatment Duration
Long-term (often continued beyond 5 years)
Evidence Quality
HIGHNumber Needed to Treat (NNT)
12(Treat 12 patients to see 1 additional successful outcome)
Number Needed to Harm (NNH)
500(Treat 500 patients to see 1 additional serious adverse event)
Confidence Score
90%confidence in effectiveness data
Health Economics
Annual Cost of Care
Drug Cost:$2,250
Monitoring:$300
Side Effect Mgmt:$150
Total Annual:$2,700
Cost-Effectiveness Analysis
Cost-Effectiveness Rating
GOODICER
$75,000/QALY
QALYs Gained
0.25
Denosumab Outcomes
for Osteoporosis
Efficacy Outcomes
Overall Effectiveness
+70%
Common Side Effects
Back pain
+18%
Musculoskeletal pain
+15%
Hypercholesterolemia
+12%
Infection (e.g., cellulitis, UTI)
+8%
Hypocalcemia
+3%
Osteonecrosis of the jaw (ONJ)
+0.05%
Atypical femoral fracture (AFF)
+0.01%
Rebound vertebral fractures upon discontinuation
+5%
Active Clinical Trials
3 active trials recruiting for Denosumab in Osteoporosis
Evaluation of Efficacy and Safety of Prolia in Subjects of Male Osteoporosis in Mainland China
NCT06332014RECRUITINGPHASE4
100 participants
INTERVENTIONAL
Beijing, China +15 more
Started: Aug 6, 2024
Romosozumab and Denosumab, Alone or Combined, in Postmenopausal Osteoporosis
NCT07283887RECRUITINGPHASE4
90 participants
INTERVENTIONAL
Douliu, Taiwan
Started: Dec 3, 2025
Comparative Efficacy, Safety, PK, and Immunogenicity Study
NCT05853354ACTIVE NOT RECRUITINGPHASE3
392 participants
INTERVENTIONAL
Thousand Oaks, United States +38 more
Started: Apr 5, 2023
Completed Clinical Trials
13 completed trials for Denosumab in Osteoporosis
A Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (Denosumab) in Japanese Postmenopausal Osteoporotic Subjects
NCT00306189COMPLETEDPHASE2
212 participants
INTERVENTIONAL
Started: Jan 1, 2006
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Denosumab (AMG 162) in Japanese Postmenopausal Women
NCT03822078COMPLETEDPHASE1
45 participants
INTERVENTIONAL
Started: Sep 30, 2003
A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis
NCT02157948COMPLETEDPHASE3
394 participants
INTERVENTIONAL
Santa Maria, United States +22 more
Started: May 1, 2014
A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis
NCT00089791COMPLETEDPHASE3
7.81K participants
INTERVENTIONAL
Started: Aug 1, 2004
Extension Study to Evaluate the Long Term Safety and Efficacy of Denosumab in the Treatment of Osteoporosis
NCT00523341COMPLETEDPHASE3
4.55K participants
INTERVENTIONAL
Started: Aug 7, 2007
Prospective Observational Study to Describe Characteristics and Management of Patients Treated With Denosumab (Prolia®) in Routine Clinical Practice
NCT01652690COMPLETED
600 participants
OBSERVATIONAL
Brno, Czechia +28 more
Started: Jun 26, 2012
Denosumab in Current Users of Bisphosphonates for Glucocorticoid-induced Osteoporosis
NCT01465568COMPLETEDPHASE4
40 participants
INTERVENTIONAL
Hong Kong, China
Started: Dec 1, 2011
A Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 in Postmenopausal Women With Osteoporosis
NCT04934072COMPLETEDPHASE3
553 participants
INTERVENTIONAL
Sofia, Bulgaria +75 more
Started: Jun 16, 2021
Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND
NCT05395091COMPLETEDPHASE3
532 participants
INTERVENTIONAL
Plovdiv, Bulgaria +33 more
Started: Aug 23, 2022
A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis
NCT04729621COMPLETEDPHASE3
332 participants
INTERVENTIONAL
Phoenix, United States +77 more
Started: Mar 22, 2021
Denosumab Versus Bisphosphonates (Alendronate) in GIOP
NCT03005678COMPLETEDPHASE4
140 participants
INTERVENTIONAL
Hong Kong, China
Started: Apr 1, 2017
Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis
NCT05087030COMPLETEDPHASE3
473 participants
INTERVENTIONAL
Miami, United States +58 more
Started: Sep 21, 2021
A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis
NCT04664959COMPLETEDPHASE3
457 participants
INTERVENTIONAL
Krakow, Poland +4 more
Started: Nov 26, 2020
Showing 20 of 155 total trials