Isoflavone Treatment for Postmenopausal Osteopenia.

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02174666
• Other study ID #: KLKN 14-04-2014
• Secondary ID: DASTI
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: November 2016

Study information

• Verified date: December 2023
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: November 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteopenia
• Osteoporosis

Intervention

Dietary Supplement:
• Red clover extract
Aglycone isoflavones 80mg/d
• Supplementation (placebo)

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus	Central Jutland Region

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	European Regional Development Fund, The Ministry of Science, Technology and Innovation, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma C-terminal telopeptide (CTX)	Bone mineral resorption biomarker.	0 - 12 months
Secondary	Bone mineral density via dual energy X-ray absorptiometry	Objective measure of bone mineral density and bone mineral content.	0 - 12 months