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

NCT04149405 | Completed Phase 4 Results FDA Drug

• 1 other identifier: KAEK 2016/100
• Study Type: interventional
• Target: 43
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoporosis, Postmenopausal; Periodontitis

Keywords

sclerostin; dickkopf-related protein-1

Outcome Measures

Primary Outcomes (2)

• Sost Values for 6th Month

  levels of sclerostin in 6th month

  6 months

• Dkk-1 Values for 6th Month

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

  6 months

Secondary Outcomes (2)

• Sost Values for 12th Month

  12 month

• Dkk-1 Values for 12th Month

  12 months

Study Arms (4)

Group A

ACTIVE COMPARATOR

* 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.

Procedure: Phase 1 periodontal therapy; Drug: Bisphosphonate therapy

Group B

ACTIVE COMPARATOR

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

Procedure: Phase 1 periodontal therapy

Group C

ACTIVE COMPARATOR

* 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.

Drug: Bisphosphonate therapy

Group D

NO INTERVENTION

* Systemically and periodontally healthy controls * No intervention has been made.

Interventions

Phase 1 periodontal therapy PROCEDURE

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

Also known as: Periodontal treatment

Group A; Group B

Bisphosphonate therapy DRUG

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

Also known as: Osteoporosis treatment

Group A; Group C

Eligibility Criteria

• Age: 51 Years - 66 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Related Publications (6)

• 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.

  PMID: 23702386 BACKGROUND

• 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.

  PMID: 1581119 BACKGROUND

• 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.

  PMID: 26435630 BACKGROUND

• 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.

  PMID: 16018754 RESULT

• 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.

  PMID: 26367496 RESULT

• 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.

  PMID: 24576302 RESULT

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Periodontitis; Sclerosteosis

Interventions

Periodontal Index

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Health Surveys; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Dentistry; Periodontics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Dentistry

Results Point of Contact

• Title: Feyza Otan Özden
• Organization: OndokusMU

feyza_otan@yahoo.com

+905322535106

Study Officials

• Eser Acarel, PhD,Prof.Dr.

  Ondokuz Mayıs University, School of Dentistry, Department of Periodontology

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 12, 2019
• First Posted: November 4, 2019
• Study Start: June 30, 2016
• Primary Completion: December 6, 2017
• Study Completion: December 28, 2018
• Last Updated: March 11, 2021
• Results First Posted: December 1, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share