Effects of Lagenbone on Bone Mineral Density
Effects of Lagenbone on Improvements in Bone Mineral Density - A Pilot Study
1 other identifier
interventional
10
1 country
1
Brief Summary
To study the effects of the herbal supplement Lagenbone on Bone Mineral Density
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 15, 2019
CompletedFirst Submitted
Initial submission to the registry
April 30, 2020
CompletedFirst Posted
Study publicly available on registry
September 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 13, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 13, 2022
CompletedApril 19, 2023
April 1, 2023
3 years
April 30, 2020
April 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (3)
Short Osteoporosis Quality of Life Questionnaire (ECOS16)
15 months
36-item Short form survey (SF36)
15 months
Osteoporotic Quality of Life Questionnaire (OQLQ10)
15 months
Study Arms (1)
Lagenbone
EXPERIMENTALLagenbone 500mg capsules, 8 capsules by mouth every day for 12 months.
Interventions
Traditional Chinese medicine herbal formula
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of osteoporosis
- Able to read and understand English
- Willing to receive routine DEXA scans and comply with supplement schedule
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Southern California University of Health Sciences
Whittier, California, 90604, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prasad S Vinjamury, DACM, MPH
Southern California University of Health Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Research Director
Study Record Dates
First Submitted
April 30, 2020
First Posted
September 21, 2020
Study Start
July 15, 2019
Primary Completion
July 13, 2022
Study Completion
July 13, 2022
Last Updated
April 19, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share