Effects of Lagenbone on Bone Mineral Density | NCT04557553

Studies
Effects of Lagenbone on Bone Mineral Density

NCT04557553

Sponsor

Southern California University of Health Sciences

Status

Completed

Last Update Posted

Apr 19, 2023Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Osteoporosis

Interventions

Lagenbone

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2019Actual

Primary Completion Date

Jul 13, 2022Actual

Completion Date

Jul 13, 2022Actual

First Submitted Date

Apr 30, 2020

First Submission Date that Met QC Criteria

Sep 15, 2020

First Posted Date

Sep 21, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2023

Last Update Posted Date

Apr 19, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sivarama Vinjamury, Professor, Research Director, Southern California University of Health SciencesPrincipal Investigator

Lead Sponsor

Southern California University of Health SciencesOTHER

Collaborators

Name	Class
Sun Ten Pharmaceutical Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To study the effects of the herbal supplement Lagenbone on Bone Mineral Density

Detailed Description

To study the effects of the herbal supplement Lagenbone on Bone Mineral Density. Lagenbone is a supplement based on the Chinese Herbal formula Gui Lu Er Xian Jiao.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lagenbone	Experimental	Lagenbone 500mg capsules, 8 capsules by mouth every day for 12 months.	Dietary Supplement: Lagenbone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lagenbone	Dietary Supplement	Traditional Chinese medicine herbal formula	Lagenbone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dual-energy x-ray absorptiometry (DXA)DEXA Scan	Dual-energy x-ray absorptiometry (DXA) or bone densitometry or Bone Density Scan	15 months

Secondary Outcomes

Measure	Description	Time Frame
Short Osteoporosis Quality of Life Questionnaire (ECOS16)	Short Osteoporosis Quality of Life Questionnaire	15 months
36-item Short form survey (SF36)	36-item Short form survey

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed diagnosis of osteoporosis
Able to read and understand English
Willing to receive routine DEXA scans and comply with supplement schedule

Exclusion Criteria:

Pregnant, lactating, or having gestational diabetes
Diagnosed with comorbid conditions that they are taking medication for e.g. Acid reflux, Hashimoto's/Grave's Disease, Endometriosis, prostate, breast, uterine cancer, kidney disease, fibroids, psychological disorders
Use of any medication known to interfere with bone mineral density
Are taking any new medications/supplements/treatments/therapeutic exercise within the last two months for osteoporosis or bone density
Involved in health-related litigation, claims
Missing baseline visits
Vegan or vegetarian
Diagnosed with Alzheimer's or demonstrating onset of dementia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Prasad S Vinjamury, DACM, MPH	Southern California University of Health Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Southern California University of Health Sciences		Whittier	California	90604	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010024	Osteoporosis

Ancestor Terms

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided