search
Back to results

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

Primary Purpose

Osteoporosis, Postmenopausal, Periodontitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Phase 1 periodontal therapy
Bisphosphonate therapy
Sponsored by
Ondokuz Mayıs University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Osteoporosis, Postmenopausal focused on measuring sclerostin, dickkopf-related protein-1

Eligibility Criteria

51 Years - 66 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    No Intervention

    Arm Label

    Group A

    Group B

    Group C

    Group D

    Arm Description

    Subjects with chronic periodontitis and osteoporosis. Phase 1 periodontal therapy and bisphosphonate therapy ( Aclasta: intravenous infusion of 5 mg of zoledronic acid once a year) were administered to the subjects.

    Subjects with chronic periodontitis and systemically healthy. Phase 1 periodontal theraphy was administered to the subjects.

    Subjects with periodontally healthy and osteoporosis. Bisphosphonate therapy ( Aclasta: intravenous infusion of 5 mg of zoledronic acid once a year) were administered to the subjects.

    Systemically and periodontally healthy controls No intervention has been made.

    Outcomes

    Primary Outcome Measures

    Sost Values for 6th Month
    levels of sclerostin in 6th month
    Dkk-1 Values for 6th Month
    levels of dickkopf-related protein-1 in 6th month

    Secondary Outcome Measures

    Sost Values for 12th Month
    levels of sclerostin in 12th month
    Dkk-1 Values for 12th Month
    levels of dickkopf-related protein-1 in 12th month

    Full Information

    First Posted
    October 12, 2019
    Last Updated
    February 18, 2021
    Sponsor
    Ondokuz Mayıs University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04149405
    Brief Title
    Alterations of GCF Levels of Sclerostin and DKK-1 in Postmenopausal Osteoporosis
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    June 30, 2016 (Actual)
    Primary Completion Date
    December 6, 2017 (Actual)
    Study Completion Date
    December 28, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ondokuz Mayıs University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoporosis, Postmenopausal, Periodontitis
    Keywords
    sclerostin, dickkopf-related protein-1

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Non-Randomized
    Enrollment
    43 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Active Comparator
    Arm Description
    Subjects with chronic periodontitis and osteoporosis. Phase 1 periodontal therapy and bisphosphonate therapy ( Aclasta: intravenous infusion of 5 mg of zoledronic acid once a year) were administered to the subjects.
    Arm Title
    Group B
    Arm Type
    Active Comparator
    Arm Description
    Subjects with chronic periodontitis and systemically healthy. Phase 1 periodontal theraphy was administered to the subjects.
    Arm Title
    Group C
    Arm Type
    Active Comparator
    Arm Description
    Subjects with periodontally healthy and osteoporosis. Bisphosphonate therapy ( Aclasta: intravenous infusion of 5 mg of zoledronic acid once a year) were administered to the subjects.
    Arm Title
    Group D
    Arm Type
    No Intervention
    Arm Description
    Systemically and periodontally healthy controls No intervention has been made.
    Intervention Type
    Procedure
    Intervention Name(s)
    Phase 1 periodontal therapy
    Other Intervention Name(s)
    Periodontal treatment
    Intervention Description
    Scaling and root planning with ultrasonic and hand instruments under local anesthesia.
    Intervention Type
    Drug
    Intervention Name(s)
    Bisphosphonate therapy
    Other Intervention Name(s)
    Osteoporosis treatment
    Intervention Description
    Using aclasta: intravenous infusion of 5 mg of zoledronic acid once a year
    Primary Outcome Measure Information:
    Title
    Sost Values for 6th Month
    Description
    levels of sclerostin in 6th month
    Time Frame
    6 months
    Title
    Dkk-1 Values for 6th Month
    Description
    levels of dickkopf-related protein-1 in 6th month
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Sost Values for 12th Month
    Description
    levels of sclerostin in 12th month
    Time Frame
    12 month
    Title
    Dkk-1 Values for 12th Month
    Description
    levels of dickkopf-related protein-1 in 12th month
    Time Frame
    12 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    51 Years
    Maximum Age & Unit of Time
    66 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eser Acarel, PhD,Prof.Dr.
    Organizational Affiliation
    Ondokuz Mayıs University, School of Dentistry, Department of Periodontology
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23702386
    Citation
    Hampson G, Edwards S, Conroy S, Blake GM, Fogelman I, Frost ML. The relationship between inhibitors of the Wnt signalling pathway (Dickkopf-1(DKK1) and sclerostin), bone mineral density, vascular calcification and arterial stiffness in post-menopausal women. Bone. 2013 Sep;56(1):42-7. doi: 10.1016/j.bone.2013.05.010. Epub 2013 May 20.
    Results Reference
    background
    PubMed Identifier
    1581119
    Citation
    Papapoulos SE, Landman JO, Bijvoet OL, Lowik CW, Valkema R, Pauwels EK, Vermeij P. The use of bisphosphonates in the treatment of osteoporosis. Bone. 1992;13 Suppl 1:S41-9. doi: 10.1016/s8756-3282(09)80009-4.
    Results Reference
    background
    PubMed Identifier
    26435630
    Citation
    Juluri R, Prashanth E, Gopalakrishnan D, Kathariya R, Devanoorkar A, Viswanathan V, Romanos GE. Association of Postmenopausal Osteoporosis and Periodontal Disease: A Double-Blind Case-Control Study. J Int Oral Health. 2015 Sep;7(9):119-23.
    Results Reference
    background
    PubMed Identifier
    16018754
    Citation
    Lane N, Armitage GC, Loomer P, Hsieh S, Majumdar S, Wang HY, Jeffcoat M, Munoz T. Bisphosphonate therapy improves the outcome of conventional periodontal treatment: results of a 12-month, randomized, placebo-controlled study. J Periodontol. 2005 Jul;76(7):1113-22. doi: 10.1902/jop.2005.76.7.1113.
    Results Reference
    result
    PubMed Identifier
    26367496
    Citation
    Balli U, Aydogdu A, Dede FO, Turer CC, Guven B. Gingival Crevicular Fluid Levels of Sclerostin, Osteoprotegerin, and Receptor Activator of Nuclear Factor-kappaB Ligand in Periodontitis. J Periodontol. 2015 Dec;86(12):1396-404. doi: 10.1902/jop.2015.150270. Epub 2015 Sep 14.
    Results Reference
    result
    PubMed Identifier
    24576302
    Citation
    Napimoga MH, Nametala C, da Silva FL, Miranda TS, Bossonaro JP, Demasi AP, Duarte PM. Involvement of the Wnt-beta-catenin signalling antagonists, sclerostin and dickkopf-related protein 1, in chronic periodontitis. J Clin Periodontol. 2014 Jun;41(6):550-7. doi: 10.1111/jcpe.12245.
    Results Reference
    result

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs