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Completed

NCT Number: NCT04557553

Effects of Lagenbone on Bone Mineral Density

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

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southern California University of Health Sciences

Whittier, California, 90604, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lagenbone

Dietary Supplement

Traditional Chinese medicine herbal formula

Other names: Gui Lu Er Xian Jiao

Primary outcomes

  1. Dual-energy x-ray absorptiometry (DXA)DEXA Scan

    Time frame: 15 months

    Dual-energy x-ray absorptiometry (DXA) or bone densitometry or Bone Density Scan

Secondary outcomes

  1. Short Osteoporosis Quality of Life Questionnaire (ECOS16)

    Time frame: 15 months

    Short Osteoporosis Quality of Life Questionnaire

  2. 36-item Short form survey (SF36)

    Time frame: 15 months

    36-item Short form survey

  3. Osteoporotic Quality of Life Questionnaire (OQLQ10)

    Time frame: 15 months

    Osteoporotic Quality of Life Questionnaire

Sponsors and collaborators

Lead sponsor

Southern California University of Health Sciences

Other

Collaborators

  • Sun Ten Pharmaceutical Co., Ltd.

Registry information

Official study title

Effects of Lagenbone on Improvements in Bone Mineral Density - A Pilot Study

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 21, 2020
Registry last updated
Apr 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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