NCT04149405

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Ondokuz Mayıs University · Academic / Other
• Sex: Female
• Age: 51 Years – 66 Years
• Healthy volunteers: Accepted

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.

Conditions

• Osteoporosis, Postmenopausal
• Periodontitis

Interventions

Type	Name	Description
PROCEDURE	Phase 1 periodontal therapy	Scaling and root planning with ultrasonic and hand instruments under local anesthesia.
DRUG	Bisphosphonate therapy	Using aclasta: intravenous infusion of 5 mg of zoledronic acid once a year

Timeline

• Start date: 2016-06-30
• Primary completion: 2017-12-06
• Completion: 2018-12-28
• First posted: 2019-11-04
• Last updated: 2021-03-11
• Results posted: 2020-12-01

Regulatory

• FDA-regulated drug study