NCT04149405

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

Completed Phase 4 Results posted Last updated 11 March 2021

What this trial tests

Phase 4 trial testing Phase 1 periodontal therapy in Osteoporosis, Postmenopausal in 43 participants. Completed in 28 December 2018.

Timeline

30 June 2016

Primary endpoint
6 December 2017

28 December 2018

Quick facts

Lead sponsor	Ondokuz Mayıs University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	diagnostic
Enrollment	43
Start date	30 June 2016
Primary completion	6 December 2017
Estimated completion	28 December 2018

Drugs / interventions tested

• Phase 1 periodontal therapy
• Bisphosphonate therapy — full drug profile →

Conditions studied

• Osteoporosis, Postmenopausal — all drugs for Osteoporosis, Postmenopausal →
• Periodontitis — all drugs for Periodontitis →

Sponsor

Ondokuz Mayıs University

Who can join

Adults 51 to 66, female only, with Osteoporosis, Postmenopausal or Periodontitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Sost Values for 6th Month Primary · 6 months

levels of sclerostin in 6th month

Group	Value	95% CI
Group A	1389.177	± 670.834
Group B	1085.405	± 618.136
Group C	1596.585	± 841.026
Group D	2131.87	± 485.78

Dkk-1 Values for 6th Month Primary · 6 months

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

Group	Value	95% CI
Group A	3358.265	± 1477.199
Group B	1963.185	± 966.451
Group C	3263.665	± 2298.590
Group D	4269.39	± 1734.73

Sost Values for 12th Month Secondary · 12 month

levels of sclerostin in 12th month

Group	Value	95% CI
Group A	1702.265	± 1012.124
Group B	1347.330	± 876.383
Group C	1114.988	± 368.840
Group D	2131.87	± 485.78

Dkk-1 Values for 12th Month Secondary · 12 months

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

Group	Value	95% CI
Group A	3440.67	± 2347.112
Group B	3203.802	± 1706.081
Group C	2490.553	± 841.512
Group D	4269.39	± 1734.73

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.