Trial Outcomes & Findings for Denosumab (DMAB) Discontinuation And Switching In Glucocorticoid-Induced Osteoporosis (GIOP): A Pilot Study (NCT NCT04177940)
NCT ID: NCT04177940
Last Updated: 2026-04-23
Results Overview
Absolute difference in the log-transformed CTX Values between randomization (V4) and 6 months after randomization (V6)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
45 participants
Primary outcome timeframe
from randomization (V4) through 6 months post randomization (V6)
Results posted on
2026-04-23
Participant Flow
Participant milestones
| Measure |
Denosumab (DMAB) to Alendronate (ALN)
Switch from Denosumab 60 mg administered subcutaneously (SC) to weekly oral alendronate (70 mg; started 6 months after last denosumab dose)
|
DMAB to "Early" Zoledronic Acid (ZA)
Switch from Denosumab 60 mg administered subcutaneously (SC) to one "early" zoledronic acid infusion (5 mg; 6 months after last denosumab dose)
|
DMAB to "Late" ZA
Switch from Denosumab 60 mg administered subcutaneously (SC) to one "late" zoledronic acid infusion (5 mg; 9 months after last denosumab dose)
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
14
|
16
|
|
Overall Study
COMPLETED
|
15
|
14
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Denosumab (DMAB) Discontinuation And Switching In Glucocorticoid-Induced Osteoporosis (GIOP): A Pilot Study
Baseline characteristics by cohort
| Measure |
Denosumab (DMAB) to Alendronate (ALN)
n=15 Participants
Switch from Denosumab 60 mg administered subcutaneously (SC) to weekly oral alendronate (70 mg; started 6 months after last denosumab dose)
|
DMAB to "Early" Zoledronic Acid (ZA)
n=14 Participants
Switch from Denosumab 60 mg administered subcutaneously (SC) to one "early" zoledronic acid infusion (5 mg; 6 months after last denosumab dose)
|
DMAB to "Late" ZA
n=16 Participants
Switch from Denosumab 60 mg administered subcutaneously (SC) to one "late" zoledronic acid infusion (5 mg; 9 months after last denosumab dose)
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65.4 years
STANDARD_DEVIATION 10.56 • n=60 Participants
|
66.8 years
STANDARD_DEVIATION 11.81 • n=56 Participants
|
58.3 years
STANDARD_DEVIATION 14.91 • n=116 Participants
|
63.3 years
STANDARD_DEVIATION 12.9 • n=7 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=60 Participants
|
9 Participants
n=56 Participants
|
12 Participants
n=116 Participants
|
32 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=60 Participants
|
5 Participants
n=56 Participants
|
4 Participants
n=116 Participants
|
13 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
African American/Black
|
1 Participants
n=60 Participants
|
1 Participants
n=56 Participants
|
5 Participants
n=116 Participants
|
7 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
1 Participants
n=116 Participants
|
2 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
12 Participants
n=60 Participants
|
13 Participants
n=56 Participants
|
10 Participants
n=116 Participants
|
35 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
1 Participants
n=7 Participants
|
|
Serum C-Terminal Telopeptide (CTX), ng/mL
|
0.07 ng/mL
STANDARD_DEVIATION 0.06 • n=60 Participants
|
0.05 ng/mL
STANDARD_DEVIATION 0.05 • n=56 Participants
|
0.11 ng/mL
STANDARD_DEVIATION 0.16 • n=116 Participants
|
0.08 ng/mL
STANDARD_DEVIATION 0.10 • n=7 Participants
|
PRIMARY outcome
Timeframe: from randomization (V4) through 6 months post randomization (V6)Absolute difference in the log-transformed CTX Values between randomization (V4) and 6 months after randomization (V6)
Outcome measures
| Measure |
DMAB to "Early" Zoledronic Acid (ZA)
n=14 Participants
Switch from Denosumab 60 mg administered subcutaneously (SC) to one "early" zoledronic acid infusion (5 mg; 6 months after last denosumab dose)
|
DMAB to "Late" ZA
n=16 Participants
Switch from Denosumab 60 mg administered subcutaneously (SC) to one "late" zoledronic acid infusion (5 mg; 9 months after last denosumab dose)
|
Denosumab (DMAB) to Alendronate (ALN)
n=15 Participants
Switch from Denosumab 60 mg administered subcutaneously (SC) to weekly oral alendronate (70 mg; started 6 months after last denosumab dose)
|
|---|---|---|---|
|
Absolute Difference in the Log-transformed CTX Values Between V4 vs. V6
|
71.79 log (ng/mL)
Standard Deviation 69.03
|
107.62 log (ng/mL)
Standard Deviation 68.93
|
129.15 log (ng/mL)
Standard Deviation 74.25
|
Adverse Events
Denosumab (DMAB) to Alendronate (ALN)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
DMAB to "Early" Zoledronic Acid (ZA)
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
DMAB to "Late" ZA
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Denosumab (DMAB) to Alendronate (ALN)
n=15 participants at risk
Switch from Denosumab 60 mg administered subcutaneously (SC) to weekly oral alendronate (70 mg; started 6 months after last denosumab dose)
|
DMAB to "Early" Zoledronic Acid (ZA)
n=14 participants at risk
Switch from Denosumab 60 mg administered subcutaneously (SC) to one "early" zoledronic acid infusion (5 mg; 6 months after last denosumab dose)
|
DMAB to "Late" ZA
n=16 participants at risk
Switch from Denosumab 60 mg administered subcutaneously (SC) to one "late" zoledronic acid infusion (5 mg; 9 months after last denosumab dose)
|
|---|---|---|---|
|
Cardiac disorders
Cardiac and circulatory problems
|
0.00%
0/15 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/14 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
6.2%
1/16 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
|
Infections and infestations
Infection
|
0.00%
0/15 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
14.3%
2/14 • Number of events 3 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
6.2%
1/16 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
Other adverse events
| Measure |
Denosumab (DMAB) to Alendronate (ALN)
n=15 participants at risk
Switch from Denosumab 60 mg administered subcutaneously (SC) to weekly oral alendronate (70 mg; started 6 months after last denosumab dose)
|
DMAB to "Early" Zoledronic Acid (ZA)
n=14 participants at risk
Switch from Denosumab 60 mg administered subcutaneously (SC) to one "early" zoledronic acid infusion (5 mg; 6 months after last denosumab dose)
|
DMAB to "Late" ZA
n=16 participants at risk
Switch from Denosumab 60 mg administered subcutaneously (SC) to one "late" zoledronic acid infusion (5 mg; 9 months after last denosumab dose)
|
|---|---|---|---|
|
Infections and infestations
urinary tract infection
|
0.00%
0/15 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/14 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
12.5%
2/16 • Number of events 2 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
|
Infections and infestations
erysipelas
|
6.7%
1/15 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/14 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/16 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
|
Infections and infestations
upper respiratory infection
|
0.00%
0/15 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
7.1%
1/14 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/16 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
|
Infections and infestations
Herpes Zoster
|
6.7%
1/15 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
7.1%
1/14 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/16 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
|
Infections and infestations
COVID-19
|
0.00%
0/15 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
7.1%
1/14 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
6.2%
1/16 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
|
Infections and infestations
Viral oral infection
|
0.00%
0/15 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/14 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
6.2%
1/16 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
|
Infections and infestations
Necrotizing fasciitis Streptococcus pyogenes
|
0.00%
0/15 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
7.1%
1/14 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/16 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
|
Infections and infestations
Urinary Tract Infection
|
6.7%
1/15 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/14 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/16 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
0.00%
0/15 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
7.1%
1/14 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/16 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
|
Musculoskeletal and connective tissue disorders
Compression fracture
|
0.00%
0/15 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
7.1%
1/14 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/16 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
|
Musculoskeletal and connective tissue disorders
Rib fracture
|
0.00%
0/15 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/14 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
6.2%
1/16 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
0.00%
0/15 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/14 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
6.2%
1/16 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
|
Musculoskeletal and connective tissue disorders
back pain
|
6.7%
1/15 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/14 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/16 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
|
Nervous system disorders
Headache, intermittent
|
0.00%
0/15 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/14 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
6.2%
1/16 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/14 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/16 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
|
Respiratory, thoracic and mediastinal disorders
Progression of interstitial lung disease (ILD)
|
6.7%
1/15 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/14 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/16 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
|
Skin and subcutaneous tissue disorders
Sores in nasal passage
|
0.00%
0/15 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
7.1%
1/14 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/16 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
|
Skin and subcutaneous tissue disorders
injection site reaction
|
0.00%
0/15 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
7.1%
1/14 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/16 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/15 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
7.1%
1/14 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/16 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
|
Cardiac disorders
Hypotension
|
6.7%
1/15 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/14 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/16 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/15 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
7.1%
1/14 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/16 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
|
Immune system disorders
Lupus flare
|
0.00%
0/15 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/14 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
6.2%
1/16 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
|
Gastrointestinal disorders
Small bowel obstruction
|
0.00%
0/15 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
7.1%
1/14 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/16 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
6.7%
1/15 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/14 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/16 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
|
General disorders
Fever
|
0.00%
0/15 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/14 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
6.2%
1/16 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
|
General disorders
Fall
|
6.7%
1/15 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/14 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/16 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
|
General disorders
fever and chills post-infusion
|
0.00%
0/15 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
7.1%
1/14 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/16 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
|
General disorders
Altered mental status
|
6.7%
1/15 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/14 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/16 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/15 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/14 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
6.2%
1/16 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
|
Cardiac disorders
Acute femoral artery occlusive disease
|
0.00%
0/15 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
7.1%
1/14 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/16 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/15 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/14 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
6.2%
1/16 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
|
Endocrine disorders
Hypocalcemia
|
0.00%
0/15 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
7.1%
1/14 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/16 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
|
Eye disorders
Anterior Ischemic Optic Neuropathy (AION)
|
6.7%
1/15 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/14 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/16 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
1/15 • Number of events 1 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/14 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
0.00%
0/16 • starting at visit 2 until visit 7/end of study visit/ 12 months post-randomization
|
Additional Information
Kenneth Saag, MD, MSc
University of Alabama at Birmingham Division of Clinical Immunology and Rheumatology
Phone: 205-996-9784
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place