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Isoflavone Treatment for Postmenopausal Osteopenia.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02174666
Recruitment Status : Unknown
Verified December 2015 by Per Bendix Jeppesen, University of Aarhus.
Recruitment status was:  Active, not recruiting
First Posted : June 25, 2014
Last Update Posted : December 15, 2015
European Regional Development Fund
The Ministry of Science, Technology and Innovation, Denmark
Information provided by (Responsible Party):
Per Bendix Jeppesen, University of Aarhus

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteopenia Osteoporosis Dietary Supplement: Red clover extract Dietary Supplement: Supplementation (placebo) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Red Clover Treatment on Bone Tissue Regulation in Postmenopausal Osteopenia.
Study Start Date : June 2014
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals
Drug Information available for: Red clover

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:
  • Formononetin
  • Biochanin A
  • Genistein
  • Daidzein
  • Vitamin D
  • Magnesium
  • Calcium

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

Primary Outcome Measures :
  1. Plasma C-terminal telopeptide (CTX) [ Time Frame: 0 - 12 months ]
    Bone mineral resorption biomarker.

Secondary Outcome Measures :
  1. Bone mineral density via dual energy X-ray absorptiometry [ Time Frame: 0 - 12 months ]
    Objective measure of bone mineral density and bone mineral content.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02174666

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Aarhus University Hospital
Aarhus, Central Jutland Region, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
European Regional Development Fund
The Ministry of Science, Technology and Innovation, Denmark
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Principal Investigator: Per B Jeppesen, Prof PhD Department of Medicine and Endocrinology MEA, Aarhus University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Per Bendix Jeppesen, Associate Prof., PhD, University of Aarhus Identifier: NCT02174666    
Other Study ID Numbers: KLKN 14-04-2014
DASTI ( Other Identifier: The Ministry of Science, Technology and Innovation, Denmark )
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: December 15, 2015
Last Verified: December 2015
Keywords provided by Per Bendix Jeppesen, University of Aarhus:
Red clover
Bone turnover
Bone mineral density
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamin D
Biochanin A
Growth Substances
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogens, Non-Steroidal
Hormones, Hormone Substitutes, and Hormone Antagonists