Trial Outcomes & Findings for Bisphosphonates for Prevention of Post-Denosumab Bone Loss (NCT NCT03396315)
NCT ID: NCT03396315
Last Updated: 2024-05-08
Results Overview
Within-group difference (percent change) in BMD at the lumbar spine (L1-4) will be measured by Dual-energy X-ray absorptiometry (DXA) and calculated.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Baseline, 12 month
Results posted on
2024-05-08
Participant Flow
Participant milestones
| Measure |
Alendronate
Subjects will receive oral alendronate
Alendronate: oral alendronate 70 mg weekly for 12 months will be given for the prevention of osteoporosis
|
Zoledronic Acid
Subjects will receive zoledronic acid
Zoledronic Acid: single intravenous dose of zoledronic acid 5 mg will be given for the prevention of osteoporosis
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
6
|
|
Overall Study
COMPLETED
|
18
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bisphosphonates for Prevention of Post-Denosumab Bone Loss
Baseline characteristics by cohort
| Measure |
Alendronate
n=18 Participants
Subjects will receive oral alendronate
Alendronate: oral alendronate 70 mg weekly for 12 months will be given for the prevention of osteoporosis
|
Zoledronic Acid
n=6 Participants
Subjects will receive zoledronic acid
Zoledronic Acid: single intravenous dose of zoledronic acid 5 mg will be given for the prevention of osteoporosis
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
38.7 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
34.7 years
STANDARD_DEVIATION 6.3 • n=7 Participants
|
37.7 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
18 participants
n=5 Participants
|
6 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 monthWithin-group difference (percent change) in BMD at the lumbar spine (L1-4) will be measured by Dual-energy X-ray absorptiometry (DXA) and calculated.
Outcome measures
| Measure |
Alendronate
n=18 Participants
Subjects will receive oral alendronate
Alendronate: oral alendronate 70 mg weekly for 12 months will be given for the prevention of osteoporosis
|
Zoledronic Acid
n=6 Participants
Subjects will receive zoledronic acid
Zoledronic Acid: single intravenous dose of zoledronic acid 5 mg will be given for the prevention of osteoporosis
|
|---|---|---|
|
Difference in BMD at the Lumbar Spine (L1-4) Within Group
|
-1.1 percentage of change
Standard Deviation 4.8
|
-2.4 percentage of change
Standard Deviation 1.0
|
Adverse Events
Alendronate
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Zoledronic Acid
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Alendronate
n=18 participants at risk
Subjects will receive oral alendronate
Alendronate: oral alendronate 70 mg weekly for 12 months will be given for the prevention of osteoporosis
|
Zoledronic Acid
n=6 participants at risk
Subjects will receive zoledronic acid
Zoledronic Acid: single intravenous dose of zoledronic acid 5 mg will be given for the prevention of osteoporosis
|
|---|---|---|
|
Immune system disorders
Acute phase reaction
|
0.00%
0/18 • 1 year
|
83.3%
5/6 • Number of events 5 • 1 year
|
|
Skin and subcutaneous tissue disorders
Hives
|
5.6%
1/18 • Number of events 1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain
|
27.8%
5/18 • Number of events 6 • 1 year
|
33.3%
2/6 • Number of events 2 • 1 year
|
|
Immune system disorders
Covid
|
0.00%
0/18 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Nervous system disorders
Numbness
|
5.6%
1/18 • Number of events 1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
16.7%
3/18 • Number of events 3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
5.6%
1/18 • Number of events 1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
5.6%
1/18 • Number of events 1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Endocrine disorders
Hot flashes
|
16.7%
3/18 • Number of events 3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Gastrointestinal disorders
Acid regurgitation
|
5.6%
1/18 • Number of events 1 • 1 year
|
0.00%
0/6 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place