Isoflavone Treatment for Postmenopausal Osteopenia.

December 1, 2023 updated by: Per Bendix Jeppesen, University of Aarhus

The Effects of Red Clover Treatment on Bone Tissue Regulation in Postmenopausal Osteopenia.

The aim of the project is to execute a double-blind, parallel, randomized 12-month intervention trial on postmenopausal women with osteopenia (low bone mineral density), in order to determine the effects of daily intake of fermented red clover (RC) extract on estrogen dependent bone mineral resorption when compared to placebo. Both groups will recieve equivalent daily calcium, vitamin D and magnesium supplements. The project will also assess whether bioactive compounds in RC can reduce the risk of developing cardiovascular disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The project aims to determine whether red clover derived isoflavones have capabilities to exert positive effects in conditions of osteoporosis and osteopenia in states estrogen deficiency and/or dysregulation.

The cause of osteopenia in women is thought to arise from the deficiency of and/or dysregulation by estrogen on target tissues. Hormone Replacement Therapy (HRT) has proven to be an effective treatment, however it retains limited use as there is general consensus that it also increases cancer risk. Plant derived compounds that emulate the chemical structure and behaviour of estrogen (known as isoflavones) offer a compelling alternative to HRT, due to their potential to adopt the regulatory roles of estrogen without incurring equivalent negative side effects of HRT.

There are, at present, few or no direct head to head clinical trials assessing combination treatments of isoflavones, vitamin D and calcium in contrast to standard vitamin D and calcium supplementation proscribed to osteopenic patients. Research in this area will therefore provide valuable insight into the effectiveness of isoflavones to reduce resorption and/or to stimulate the formation of bone tissue. Moreover the study will provide a comprehensive assessment of the potential of isoflavones to enhance the efficacy of existing preventative treatments. Outcomes of the project have the prospect to help thousands of middle aged and PM women suffering. Moreover, the project may enable development of functional foods and/or nutraceuticals that can be used as either a preventative measure and/or as a treatment for osteoporosis in states of estrogen deficiency and thereby provide an alternative to Hormone Replacement Therapy that does involve the same side effects and risks.

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Central Jutland Region
      • Aarhus, Central Jutland Region, Denmark, 8000
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Age 50-85 years, only women
  • Have osteopenia (T score between -1 and -2.5)
  • Body Mass Index (BMI) between 20 and 40

Exclusion criteria:

  • Taken specific osteoporosis drugs (i.e. bisphosphonates, PTH, estrogen or strontium ranelate) in the past 3 months
  • Taken other selective estrogen receptor modulator preparations (raloxifene, tamoxifen or isoflavones) in the past 3 months
  • Participation in other clinical trials within the last 3 months
  • Previous history of cardiovascular, psychiatric, neurological, and / or kidney disease
  • Alcohol or substance abuse or acute illness
  • Blood pressure> 160/110
  • Pregnant and breastfeeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Red clover extract
Group recieving daily red clover extract containing isoflavones (80 mg/d), along with calcium (1040 mg/d), vitamin D (25µg/d) and magnesium (487mg/d).
Dietary supplement: Red clover extract
Aglycone isoflavones 80mg/d
Other Names:
  • Vitamin D
  • Magnesium
  • Calcium
  • Formononetin
  • Biochanin A
  • Genistein
  • Daidzein
Placebo Comparator: Placebo group
Group recieving daily placebo extract (with no isoflavone content), calcium (1040 mg/d), vitamin D (25µg/d) and magnesium (487mg/d).
Dietary supplement: Supplementation (placebo)
Other Names:
  • Vitamin D
  • Magnesium
  • Calcuim

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma C-terminal telopeptide (CTX)
Time Frame: 0 - 12 months
Bone mineral resorption biomarker.
0 - 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone mineral density via dual energy X-ray absorptiometry
Time Frame: 0 - 12 months
Objective measure of bone mineral density and bone mineral content.
0 - 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

The Ministry of Science, Technology and Innovation, Denmark
European Regional Development Fund

Investigators

  • Principal Investigator: Per B Jeppesen, Prof PhD, Department of Medicine and Endocrinology MEA, Aarhus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

June 19, 2014

First Submitted That Met QC Criteria

June 23, 2014

First Posted (Estimated)

June 25, 2014

Study Record Updates

Last Update Posted (Estimated)

December 4, 2023

Last Update Submitted That Met QC Criteria

December 1, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KLKN 14-04-2014
  • DASTI (Other Identifier: The Ministry of Science, Technology and Innovation, Denmark)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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