Trial Outcomes & Findings for Alterations of GCF Levels of Sclerostin and DKK-1 in Postmenopausal Osteoporosis (NCT NCT04149405)
NCT ID: NCT04149405
Last Updated: 2021-03-11
Results Overview
levels of sclerostin in 6th month
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
43 participants
Primary outcome timeframe
6 months
Results posted on
2021-03-11
Participant Flow
Postmenopausal women who were admitted to Ondokuz Mayıs University (OMU), Faculty of Medicine, Department of Endocrinology and Metabolism between 2016 and 2018. Patients eligible for the study were directed to OMU, Faculty of Dentistry, Department of Periodontology for periodontal examination after obtaining medical records.
Smokers and subjects who had received antibiotic treatment in the last 3 months and/or periodontal treatment in the last 6 months were excluded from the study.
Participant milestones
| Measure |
Group A
subjects with chronic periodontitis and osteoporosis
|
Group B
subjects with chronic periodontitis and systemically healthy
|
Group C
subjects with periodontally healthy and osteoporosis
|
Group D
systemically and periodontally healthy controls
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
10
|
11
|
10
|
|
Overall Study
COMPLETED
|
12
|
10
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Alterations of GCF Levels of Sclerostin and DKK-1 in Postmenopausal Osteoporosis
Baseline characteristics by cohort
| Measure |
Group A
n=12 Participants
subjects with chronic periodontitis and osteoporosis
|
Group B
n=10 Participants
subjects with chronic periodontitis and systemically healthy
|
Group C
n=11 Participants
subjects with periodontally healthy and osteoporosis
|
Group D
n=10 Participants
systemically and periodontally healthy controls
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
57.67 years
STANDARD_DEVIATION 4.77 • n=5 Participants
|
57.00 years
STANDARD_DEVIATION 4.39 • n=7 Participants
|
56.45 years
STANDARD_DEVIATION 3.88 • n=5 Participants
|
56.30 years
STANDARD_DEVIATION 3.91 • n=4 Participants
|
56.88 years
STANDARD_DEVIATION 4.15 • n=21 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Turkey
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
baseline sost values
|
494.096 ng/ml
STANDARD_DEVIATION 99.840 • n=5 Participants
|
634.731 ng/ml
STANDARD_DEVIATION 152.554 • n=7 Participants
|
1023.071 ng/ml
STANDARD_DEVIATION 512.733 • n=5 Participants
|
2131.87 ng/ml
STANDARD_DEVIATION 485.784 • n=4 Participants
|
1103.417 ng/ml
STANDARD_DEVIATION 751.080 • n=21 Participants
|
|
baseline dkk-1 levels
|
1031.323 ng/ml
STANDARD_DEVIATION 506.985 • n=5 Participants
|
1264.632 ng/ml
STANDARD_DEVIATION 492.691 • n=7 Participants
|
2630.430 ng/ml
STANDARD_DEVIATION 1679.080 • n=5 Participants
|
4269.394 ng/ml
STANDARD_DEVIATION 1734.732 • n=4 Participants
|
2358.505 ng/ml
STANDARD_DEVIATION 1801.692 • n=21 Participants
|
PRIMARY outcome
Timeframe: 6 monthslevels of sclerostin in 6th month
Outcome measures
| Measure |
Group A
n=12 Participants
scaling and root planning, bisphosphonate therapy (zoledronic acid)
periodontal phase 1 therapy: periodontal phase 1 therapy consisted of scaling and root planning with ultrasonic and hand instruments under local anesthesia.
bisphosphonate therapy: bisphosphonate therapy refers to the use of zoledronic acid 5 mg/year (i.v.)
GCF: gingival crevicular fluid collection by the same investigator.
|
Group B
n=10 Participants
scaling and root planning, no bisphosphonate therapy
periodontal phase 1 therapy: periodontal phase 1 therapy consisted of scaling and root planning with ultrasonic and hand instruments under local anesthesia.
GCF: gingival crevicular fluid collection by the same investigator.
|
Group C
n=11 Participants
bisphosphonate therapy (zoledronic acid)
bisphosphonate therapy: bisphosphonate therapy refers to the use of zoledronic acid 5 mg/year (i.v.)
GCF: gingival crevicular fluid collection by the same investigator.
|
Group D
n=10 Participants
Systemically and periodontally healthy controls No intervention has been made
|
|---|---|---|---|---|
|
Sost Values for 6th Month
|
1389.177 ng/ml
Standard Deviation 670.834
|
1085.405 ng/ml
Standard Deviation 618.136
|
1596.585 ng/ml
Standard Deviation 841.026
|
2131.87 ng/ml
Standard Deviation 485.78
|
PRIMARY outcome
Timeframe: 6 monthslevels of dickkopf-related protein-1 in 6th month
Outcome measures
| Measure |
Group A
n=12 Participants
scaling and root planning, bisphosphonate therapy (zoledronic acid)
periodontal phase 1 therapy: periodontal phase 1 therapy consisted of scaling and root planning with ultrasonic and hand instruments under local anesthesia.
bisphosphonate therapy: bisphosphonate therapy refers to the use of zoledronic acid 5 mg/year (i.v.)
GCF: gingival crevicular fluid collection by the same investigator.
|
Group B
n=10 Participants
scaling and root planning, no bisphosphonate therapy
periodontal phase 1 therapy: periodontal phase 1 therapy consisted of scaling and root planning with ultrasonic and hand instruments under local anesthesia.
GCF: gingival crevicular fluid collection by the same investigator.
|
Group C
n=11 Participants
bisphosphonate therapy (zoledronic acid)
bisphosphonate therapy: bisphosphonate therapy refers to the use of zoledronic acid 5 mg/year (i.v.)
GCF: gingival crevicular fluid collection by the same investigator.
|
Group D
n=10 Participants
Systemically and periodontally healthy controls No intervention has been made
|
|---|---|---|---|---|
|
Dkk-1 Values for 6th Month
|
3358.265 ng/ml
Standard Deviation 1477.199
|
1963.185 ng/ml
Standard Deviation 966.451
|
3263.665 ng/ml
Standard Deviation 2298.590
|
4269.39 ng/ml
Standard Deviation 1734.73
|
SECONDARY outcome
Timeframe: 12 monthlevels of sclerostin in 12th month
Outcome measures
| Measure |
Group A
n=12 Participants
scaling and root planning, bisphosphonate therapy (zoledronic acid)
periodontal phase 1 therapy: periodontal phase 1 therapy consisted of scaling and root planning with ultrasonic and hand instruments under local anesthesia.
bisphosphonate therapy: bisphosphonate therapy refers to the use of zoledronic acid 5 mg/year (i.v.)
GCF: gingival crevicular fluid collection by the same investigator.
|
Group B
n=10 Participants
scaling and root planning, no bisphosphonate therapy
periodontal phase 1 therapy: periodontal phase 1 therapy consisted of scaling and root planning with ultrasonic and hand instruments under local anesthesia.
GCF: gingival crevicular fluid collection by the same investigator.
|
Group C
n=11 Participants
bisphosphonate therapy (zoledronic acid)
bisphosphonate therapy: bisphosphonate therapy refers to the use of zoledronic acid 5 mg/year (i.v.)
GCF: gingival crevicular fluid collection by the same investigator.
|
Group D
n=10 Participants
Systemically and periodontally healthy controls No intervention has been made
|
|---|---|---|---|---|
|
Sost Values for 12th Month
|
1702.265 ng/ml
Standard Deviation 1012.124
|
1347.330 ng/ml
Standard Deviation 876.383
|
1114.988 ng/ml
Standard Deviation 368.840
|
2131.87 ng/ml
Standard Deviation 485.78
|
SECONDARY outcome
Timeframe: 12 monthslevels of dickkopf-related protein-1 in 12th month
Outcome measures
| Measure |
Group A
n=12 Participants
scaling and root planning, bisphosphonate therapy (zoledronic acid)
periodontal phase 1 therapy: periodontal phase 1 therapy consisted of scaling and root planning with ultrasonic and hand instruments under local anesthesia.
bisphosphonate therapy: bisphosphonate therapy refers to the use of zoledronic acid 5 mg/year (i.v.)
GCF: gingival crevicular fluid collection by the same investigator.
|
Group B
n=10 Participants
scaling and root planning, no bisphosphonate therapy
periodontal phase 1 therapy: periodontal phase 1 therapy consisted of scaling and root planning with ultrasonic and hand instruments under local anesthesia.
GCF: gingival crevicular fluid collection by the same investigator.
|
Group C
n=11 Participants
bisphosphonate therapy (zoledronic acid)
bisphosphonate therapy: bisphosphonate therapy refers to the use of zoledronic acid 5 mg/year (i.v.)
GCF: gingival crevicular fluid collection by the same investigator.
|
Group D
n=10 Participants
Systemically and periodontally healthy controls No intervention has been made
|
|---|---|---|---|---|
|
Dkk-1 Values for 12th Month
|
3440.67 ng/ml
Standard Deviation 2347.112
|
3203.802 ng/ml
Standard Deviation 1706.081
|
2490.553 ng/ml
Standard Deviation 841.512
|
4269.39 ng/ml
Standard Deviation 1734.73
|
Adverse Events
Group A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group C
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group D
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place