Effects of Lagenbone on Bone Mineral Density

Not Applicable

Completed

• Conditions: Osteoporosis
• Interventions: Dietary Supplement: Lagenbone

• Registration Number: NCT04557553
• Lead Sponsor: Southern California University of Health Sciences

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.

Study Timeline

• Study Start: 2019-07-15
• Study First Submitted: 2020-04-30
• Study First Submitted QC: 2020-09-15
• Study First Posted: 2020-09-21
• Primary Completion: 2022-07-13
• Study Completion: 2022-07-13
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-17
• Last Update Posted: 2023-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lagenbone	Lagenbone	Lagenbone 500mg capsules, 8 capsules by mouth every day for 12 months.

Primary Outcome Measures

Name	Time	Method
Dual-energy x-ray absorptiometry (DXA)DEXA Scan	15 months	Dual-energy x-ray absorptiometry (DXA) or bone densitometry or Bone Density Scan

Secondary Outcome Measures

Name	Time	Method
Short Osteoporosis Quality of Life Questionnaire (ECOS16)	15 months	Short Osteoporosis Quality of Life Questionnaire
36-item Short form survey (SF36)	15 months	36-item Short form survey
Osteoporotic Quality of Life Questionnaire (OQLQ10)	15 months	Osteoporotic Quality of Life Questionnaire

Trial Locations

Locations (1)

Southern California University of Health Sciences; 🇺🇸 Whittier, California, United States