Trial Outcomes & Findings for Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery (NCT NCT04087096)
NCT ID: NCT04087096
Last Updated: 2025-10-29
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
36 participants
Primary outcome timeframe
Pre-operative baseline to post-operative month 19
Results posted on
2025-10-29
Participant Flow
Participant milestones
| Measure |
Denosumab
Denosumab 60mg subcutaneous injection every 6 months
Denosumab: Denosumab will be administered at postoperative months 1, 7, and 13
Zoledronic Acid: Zoledronic Acid 5mg will be administered intravenously at postoperative month 19
|
Placebo
Placebo subcutaneous injection every 6 months
Placebo: Placebo will be administered at postoperative months 1, 7, and 13
Zoledronic Acid: Zoledronic Acid 5mg will be administered intravenously at postoperative month 19
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
12
|
|
Overall Study
COMPLETED
|
24
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery
Baseline characteristics by cohort
| Measure |
Denosumab
n=24 Participants
Denosumab 60mg subcutaneous injection every 6 months
Denosumab: Denosumab will be administered at postoperative months 1, 7, and 13
Zoledronic Acid: Zoledronic Acid 5mg will be administered intravenously at postoperative month 19
|
Placebo
n=12 Participants
Placebo subcutaneous injection every 6 months
Placebo: Placebo will be administered at postoperative months 1, 7, and 13
Zoledronic Acid: Zoledronic Acid 5mg will be administered intravenously at postoperative month 19
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.71 years
STANDARD_DEVIATION 5.03 • n=5 Participants
|
56.58 years
STANDARD_DEVIATION 10.04 • n=7 Participants
|
56.67 years
STANDARD_DEVIATION 6.95 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
12 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Pre-Op Body Mass Index (BMI)
|
43.9 kg/m2
STANDARD_DEVIATION 5.59 • n=5 Participants
|
43.8 kg/m2
STANDARD_DEVIATION 6.36 • n=7 Participants
|
43.87 kg/m2
STANDARD_DEVIATION 5.76 • n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-operative baseline to post-operative month 19Outcome measures
| Measure |
Denosumab
n=24 Participants
Denosumab 60mg subcutaneous injection every 6 months
Denosumab: Denosumab will be administered at postoperative months 1, 7, and 13
Zoledronic Acid: Zoledronic Acid 5mg will be administered intravenously at postoperative month 19
|
Placebo
n=12 Participants
Placebo subcutaneous injection every 6 months
Placebo: Placebo will be administered at postoperative months 1, 7, and 13
Zoledronic Acid: Zoledronic Acid 5mg will be administered intravenously at postoperative month 19
|
|---|---|---|
|
Percentage Change in Total Hip Bone Mineral Density
|
0.60 percentage of change
Interval -0.66 to 1.87
|
-6.44 percentage of change
Interval -8.74 to -4.13
|
Adverse Events
Denosumab
Serious events: 5 serious events
Other events: 24 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Denosumab
n=24 participants at risk
Denosumab 60mg subcutaneous injection every 6 months
Denosumab: Denosumab will be administered at postoperative months 1, 7, and 13
Zoledronic Acid: Zoledronic Acid 5mg will be administered intravenously at postoperative month 19
|
Placebo
n=12 participants at risk
Placebo subcutaneous injection every 6 months
Placebo: Placebo will be administered at postoperative months 1, 7, and 13
Zoledronic Acid: Zoledronic Acid 5mg will be administered intravenously at postoperative month 19
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Issues
|
8.3%
2/24 • Baseline to 19 months
|
0.00%
0/12 • Baseline to 19 months
|
|
General disorders
Vaccine Reaction
|
4.2%
1/24 • Baseline to 19 months
|
0.00%
0/12 • Baseline to 19 months
|
|
General disorders
Orthostasis
|
0.00%
0/24 • Baseline to 19 months
|
8.3%
1/12 • Baseline to 19 months
|
|
Gastrointestinal disorders
Other GI Issues
|
8.3%
2/24 • Baseline to 19 months
|
0.00%
0/12 • Baseline to 19 months
|
|
Injury, poisoning and procedural complications
Motor Vehicle Accident
|
0.00%
0/24 • Baseline to 19 months
|
8.3%
1/12 • Baseline to 19 months
|
Other adverse events
| Measure |
Denosumab
n=24 participants at risk
Denosumab 60mg subcutaneous injection every 6 months
Denosumab: Denosumab will be administered at postoperative months 1, 7, and 13
Zoledronic Acid: Zoledronic Acid 5mg will be administered intravenously at postoperative month 19
|
Placebo
n=12 participants at risk
Placebo subcutaneous injection every 6 months
Placebo: Placebo will be administered at postoperative months 1, 7, and 13
Zoledronic Acid: Zoledronic Acid 5mg will be administered intravenously at postoperative month 19
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Issues
|
91.7%
22/24 • Baseline to 19 months
|
91.7%
11/12 • Baseline to 19 months
|
|
Skin and subcutaneous tissue disorders
Skin Rash or Discomfort
|
50.0%
12/24 • Baseline to 19 months
|
33.3%
4/12 • Baseline to 19 months
|
|
Nervous system disorders
Tingling/numbness
|
37.5%
9/24 • Baseline to 19 months
|
41.7%
5/12 • Baseline to 19 months
|
|
Gastrointestinal disorders
Nausea
|
8.3%
2/24 • Baseline to 19 months
|
0.00%
0/12 • Baseline to 19 months
|
|
Gastrointestinal disorders
Other GI Issues
|
25.0%
6/24 • Baseline to 19 months
|
16.7%
2/12 • Baseline to 19 months
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
4.2%
1/24 • Baseline to 19 months
|
16.7%
2/12 • Baseline to 19 months
|
|
General disorders
Dental Issues
|
25.0%
6/24 • Baseline to 19 months
|
33.3%
4/12 • Baseline to 19 months
|
|
Infections and infestations
COVID infection
|
20.8%
5/24 • Baseline to 19 months
|
25.0%
3/12 • Baseline to 19 months
|
|
General disorders
Confusion
|
12.5%
3/24 • Baseline to 19 months
|
8.3%
1/12 • Baseline to 19 months
|
|
General disorders
Lightheadedness/dizziness
|
20.8%
5/24 • Baseline to 19 months
|
8.3%
1/12 • Baseline to 19 months
|
|
Investigations
Abnormal Labs
|
12.5%
3/24 • Baseline to 19 months
|
0.00%
0/12 • Baseline to 19 months
|
|
Blood and lymphatic system disorders
Anemia
|
4.2%
1/24 • Baseline to 19 months
|
8.3%
1/12 • Baseline to 19 months
|
|
Gastrointestinal disorders
Constipation
|
12.5%
3/24 • Baseline to 19 months
|
0.00%
0/12 • Baseline to 19 months
|
|
Psychiatric disorders
Depression
|
8.3%
2/24 • Baseline to 19 months
|
0.00%
0/12 • Baseline to 19 months
|
|
Eye disorders
Eye Irritation
|
4.2%
1/24 • Baseline to 19 months
|
8.3%
1/12 • Baseline to 19 months
|
|
Surgical and medical procedures
Eye Procedure
|
8.3%
2/24 • Baseline to 19 months
|
0.00%
0/12 • Baseline to 19 months
|
|
General disorders
Headache
|
8.3%
2/24 • Baseline to 19 months
|
0.00%
0/12 • Baseline to 19 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place