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Alterations of GCF Levels of Sclerostin and DKK-1 in Postmenopausal Osteoporosis

Investigation of the Effects of Bisphosphonate on the Gingival Crevicular Fluid Levels of Sclerostin and the DKK-1 in Individuals With Postmenopausal Osteoporosis With Periodontal Changes

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04149405
Enrollment
43
Registered
2019-11-04
Start date
2016-06-30
Completion date
2018-12-28
Last updated
2021-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis, Postmenopausal, Periodontitis

Keywords

sclerostin, dickkopf-related protein-1

Brief summary

Symptoms of periodontal disease are tissue destruction and destruction of the alveolar bone which supports the tooth. Wnt way (wingless-type MMTV integration site family) plays a role in the regulation of bone homeostasis in periodontal disease-induced bone resorption. The Wnt / β-catenin signal is controlled by physiological antagonists, including dickkopf released from osteocytes-associated protein 1 (DKK-1) and sclerostin (SOST). Thus, Wnt inhibitors SOST and DKK-1 affect bone mass changes. Bisphosphonates used in osteoporous treatment are selective inhibitors of bone resorption. In the serum of postmenopausal osteoporotic women treated with bisphosphonate, short-term and decreased DKK-1 level during the treatment, and increased SOST in the late period were reported. Increased bone formation after bisphosphonate treatment in postmenopausal osteoporotic patients has been associated with increased serum SOST level. The aim of our study is to investigate the effect of bisphosphonate in patients with post-menopausal osteoporosis on the bone demolition metabolism in periodontally healthy and periodontally diseased tooth regions and gingival health with the clinical data by investigating the SOST and DDK-1 molecules that play role in bone destruction mechanism.

Detailed description

This study aims to reveal the effect of initial periodontal treatment together with bisphosphonate on sclerostin (SOST) and dickkopf-related protein-1 (DKK-1) in gingival crevicular fluid (GCF) of patients with osteoporosis. Clinical recordings and GCF were obtained from postmenopausal women; with chronic periodontitis and those using bisphosphonate (Group A, n=12), with chronic periodontitis and otherwise healthy (Group B, n=10), without chronic periodontitis and those using bisphosphonate (Group C, n=11), systemically and periodontally healthy controls (Group D, n=10) at the baseline. GCF sampling were recorded and repeated at the 6th and 12th months in Group A, B and C. SOST and DKK-1 values were measured by ELISA.

Interventions

PROCEDUREPhase 1 periodontal therapy

Scaling and root planning with ultrasonic and hand instruments under local anesthesia.

DRUGBisphosphonate therapy

Using aclasta: intravenous infusion of 5 mg of zoledronic acid once a year

Sponsors

Ondokuz Mayıs University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
51 Years to 66 Years
Healthy volunteers
Yes

Inclusion criteria

* Women with T scores less than -2.5 (groups A and C) * The periodontitis patients were selected based on the radiographical evidence of bone loss, presence of four or more sites with bleeding on probing (BOP), ≥5 mm pocket depth (PD) and ≥6 mm clinical attachment loss (CAL). * The clinically healthy control groups were selected on the basis of no radiographic bone loss or CAL and PD≤3 mm.

Exclusion criteria

* Any known systemic disease rather than osteoporosis * Smoking * Antibiotic therapy within the last 3 months * Periodontal treatment in the last 6 months

Design outcomes

Primary

MeasureTime frameDescription
Sost Values for 6th Month6 monthslevels of sclerostin in 6th month
Dkk-1 Values for 6th Month6 monthslevels of dickkopf-related protein-1 in 6th month

Secondary

MeasureTime frameDescription
Sost Values for 12th Month12 monthlevels of sclerostin in 12th month
Dkk-1 Values for 12th Month12 monthslevels of dickkopf-related protein-1 in 12th month

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

ArmCount
Group A
subjects with chronic periodontitis and osteoporosis
12
Group B
subjects with chronic periodontitis and systemically healthy
10
Group C
subjects with periodontally healthy and osteoporosis
11
Group D
systemically and periodontally healthy controls
10
Total43

Baseline characteristics

CharacteristicGroup BGroup AGroup CGroup DTotal
Age, Continuous57.00 years
STANDARD_DEVIATION 4.39
57.67 years
STANDARD_DEVIATION 4.77
56.45 years
STANDARD_DEVIATION 3.88
56.30 years
STANDARD_DEVIATION 3.91
56.88 years
STANDARD_DEVIATION 4.15
baseline dkk-1 levels1264.632 ng/ml
STANDARD_DEVIATION 492.691
1031.323 ng/ml
STANDARD_DEVIATION 506.985
2630.430 ng/ml
STANDARD_DEVIATION 1679.08
4269.394 ng/ml
STANDARD_DEVIATION 1734.732
2358.505 ng/ml
STANDARD_DEVIATION 1801.692
baseline sost values634.731 ng/ml
STANDARD_DEVIATION 152.554
494.096 ng/ml
STANDARD_DEVIATION 99.84
1023.071 ng/ml
STANDARD_DEVIATION 512.733
2131.87 ng/ml
STANDARD_DEVIATION 485.784
1103.417 ng/ml
STANDARD_DEVIATION 751.08
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
10 Participants12 Participants11 Participants10 Participants43 Participants
Region of Enrollment
Turkey
10 Participants12 Participants11 Participants10 Participants43 Participants
Sex: Female, Male
Female
10 Participants12 Participants11 Participants10 Participants43 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 00 / 00 / 0
other
Total, other adverse events
0 / 00 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 00 / 0

Outcome results

Primary

Dkk-1 Values for 6th Month

levels of dickkopf-related protein-1 in 6th month

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Group ADkk-1 Values for 6th Month3358.265 ng/mlStandard Deviation 1477.199
Group BDkk-1 Values for 6th Month1963.185 ng/mlStandard Deviation 966.451
Group CDkk-1 Values for 6th Month3263.665 ng/mlStandard Deviation 2298.59
Group DDkk-1 Values for 6th Month4269.39 ng/mlStandard Deviation 1734.73
p-value: <0.05Kruskal-Wallis
Primary

Sost Values for 6th Month

levels of sclerostin in 6th month

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Group ASost Values for 6th Month1389.177 ng/mlStandard Deviation 670.834
Group BSost Values for 6th Month1085.405 ng/mlStandard Deviation 618.136
Group CSost Values for 6th Month1596.585 ng/mlStandard Deviation 841.026
Group DSost Values for 6th Month2131.87 ng/mlStandard Deviation 485.78
p-value: <0.01Kruskal-Wallis
Secondary

Dkk-1 Values for 12th Month

levels of dickkopf-related protein-1 in 12th month

Time frame: 12 months

ArmMeasureValue (MEAN)Dispersion
Group ADkk-1 Values for 12th Month3440.67 ng/mlStandard Deviation 2347.112
Group BDkk-1 Values for 12th Month3203.802 ng/mlStandard Deviation 1706.081
Group CDkk-1 Values for 12th Month2490.553 ng/mlStandard Deviation 841.512
Group DDkk-1 Values for 12th Month4269.39 ng/mlStandard Deviation 1734.73
p-value: <0.05Kruskal-Wallis
Secondary

Sost Values for 12th Month

levels of sclerostin in 12th month

Time frame: 12 month

ArmMeasureValue (MEAN)Dispersion
Group ASost Values for 12th Month1702.265 ng/mlStandard Deviation 1012.124
Group BSost Values for 12th Month1347.330 ng/mlStandard Deviation 876.383
Group CSost Values for 12th Month1114.988 ng/mlStandard Deviation 368.84
Group DSost Values for 12th Month2131.87 ng/mlStandard Deviation 485.78
p-value: <0.05Kruskal-Wallis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026