Effects of Genistein Aglycone in Glucocorticoid Induced Osteoporosis

NCT03040531 | Unknown Phase 2 DMC

• 1 other identifier: 45/16
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

Prolonged glucocorticoid therapy affects bone fragility, cardiovascular health, glucidic and lipidic metabolism, thyroid and brain function. Glucocorticoid-induced osteoporosis is characterized by low bone turnover and fractures, which occur in 30-50% of patients. Glucocorticoids affect predominantly cancellous or trabecular bone, increasing the risk of vertebral fractures, which may be asymptomatic and occur early during the first months of glucocorticoid treatment. Genistein exerts biological effects by several potential mechanisms. Besides protective effects on bone loss, genistein reduces cardiovascular risk markers, improves endothelial function and ameliorates glucose and lipid metabolism. This study is aimed at demonstrating genistein efficacy in glucocorticoid-induced osteoporosis in a cohort of caucasian post-menopausal women.

Conditions

Osteoporosis, Steroid Induced

Keywords

glucocorticoid; genistein; alendronate

Outcome Measures

Primary Outcomes (3)

• Change in Bone mineral density

  BMD of lumbar spine and femoral will be measured by DEXA (dual energy x-ray absorptiometry)

  24 months

• Bone fracture

  Xrays of the lumbar spine (T4-L4) will be taken to evaluate the presence of fractures

  24 months

• Change in Bone quality

  pQCT (peripheral quantitative computed tomography) will be used for bone quality evaluation

  24 months

Secondary Outcomes (8)

• Change in Bone markers

  24 months

• Change in Cardiovascular markers

  24 months

• Change in Glucose and lipid metabolism

  24 months

• Change in Quality of life

  24 months

• Chage in skin elasticity

  24 months

Study Arms (2)

Genistein

EXPERIMENTAL

Each tablet will contain 27 mg of 98% pure genistein + 500mg Calcium + 200 IU Vit. D3. Subjects will receive 2 tablets per day 6 days/week for all the duration of the study. Once a week subjects will receive a tablet containing only 500mg Calcium + 200 IU Vit. D3.

Dietary Supplement: Genistein aglycone

Alendronate

ACTIVE COMPARATOR

Each tablet will contain 500mg Calcium + 200 IU Vit. D3. Subjects will receive 2 tablets per day 6 days/week for all the duration of the study. Once a week subjects will take one tablet containing 70mg alendronate.

Drug: Alendronate Oral Tablet; Dietary Supplement: Calcium + vitamin D3 tablet

Interventions

Genistein aglycone DIETARY_SUPPLEMENT

27mg bid in tablets

Also known as: fosteum

Genistein

Alendronate Oral Tablet DRUG

70 mg/week in tablets

Also known as: Fosamax

Alendronate

Calcium + vitamin D3 tablet DIETARY_SUPPLEMENT

500mg Calcium + 200 IU Vitamin D3 bid in tablets

Alendronate

Eligibility Criteria

• Age: 54 Years - 75 Years
• Gender Eligibility Details: Only female XX patients will be included, to avoid interactions with other steroid drugs.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• being treated with glucocorticoids (5 mg of prednisone equivalents) for the preceding 3 months or less, and expect to continue the therapy for at least 12 months;
• being post-menopausal;

You may not qualify if:

• use of other steroids or osteoporosis medications;
• have been diagnosed with metabolic bone diseases (other than glucocorticoid osteoporosis)
• previous (1 year) or current use of HRT (hormone replacement therapy)
• other diseases that may affect participation (i.e. mental illness)

Sponsors & Collaborators

• University of Messina: lead
• Ministry of Health, Italy: collaborator

Study Sites (2)

University of Messina

Messina, Italy, 98123, Italy

RECRUITING

University Hospital

Messina, 98125, Italy

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Interventions

Alendronate; Calcium; Cholecalciferol

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Francesco Squadrito, MD

  University of Messina

  STUDY DIRECTOR

Central Study Contacts

Francesco Squadrito, MD

CONTACT

+390902213648; fsquadrito@unime.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Drugs will be labelled as "A" and "B" and so will be the groups. Patients and doctors involved will not be aware of the treatment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Pharmacology

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 2, 2017
• Study Start: January 19, 2017
• Primary Completion: June 30, 2018
• Study Completion: December 30, 2018
• Last Updated: March 3, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)