Effect of the Phytoestrogen Genistein on Osteopenic Women With and Without Metabolic Syndrome - Full Text View

Sponsor:	University of Messina
Information provided by:	University of Messina
ClinicalTrials.gov Identifier:	NCT00541710

Purpose

The purpose of this study is to determine whether the phytoestrogen genistein is effective in improving bone condition in pre-menopausal and post-menopausal women suffering for osteopenia. Since, during the study the investigators realized that at least 70% of post-menopausal recruited women suffered for metabolic syndrome, we have added only in these women, as secondary outcome measures, the evaluation of markers of cardiovascular risk.

Condition	Intervention	Phase
Osteoporosis Pre-Menopausal Osteopenia Post-Menopausal Osteopenia	Drug: genistein Drug: A1 Drug: B1 Drug: C1	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Menopause Osteoporosis

Drug Information available for: Genistein

U.S. FDA Resources

Further study details as provided by University of Messina:

Primary Outcome Measures:

markers of bone reabsorption: CTX (C-telopeptide of type I collagen ) and of bone formation: bone ALP (Alkaline phosphatase), plus calcaneus ultrasonography variation values [ Time Frame: baseline and six months for markers of bone reabsorption, while baseline and 12 months for evaluation of calcaneus ultrasonography variation values ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

In a sub-group of post-menopausal women with metabolic syndrome will also be assessed some markers of cardiovascular risk [ Time Frame: baseline, 6 months and 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	180
Study Start Date:	October 2007
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator pre-menopausal osteopenic women	Drug: genistein pills of 27 mg, twice per day for 12 months, plus vit. D 400 IU and calcium 500 mg. pre-menopausal osteopenic women
B: Active Comparator early post-menopausal osteopenic women	Drug: genistein pills of 27 mg, twice per day for 12 months early post-menopausal osteopenic women
C: Active Comparator late-post-menopausal osteopenic women	Drug: genistein pills of 27 mg, twice per day for 12 months late-post-menopausal osteopenic women
A1: Placebo Comparator placebo pills containing calcium 500 mg and vit. D 400 IU	Drug: A1 placebo pills containing calcium 500 mg and vit D 400 IU
B1: Placebo Comparator placebo pills containing calcium 500 mg and vit D 400 IU	Drug: B1 placebo pills containing calcium 500 mg and vit D 400 IU
C1: Placebo Comparator placebo pills containing calcium 500 mg and vit D 400 IU	Drug: C1 placebo pills containing calcium 500 mg and vit. D 400 IU

Eligibility

Ages Eligible for Study:	45 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Women evaluated by calcaneus ultrasonography with a T score between -1 and -2.5 SD

Exclusion Criteria:

Cigarettes smoked > 10 per day.
Assumption of estrogens or biphosphonates in the last six months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00541710

Contacts

Contact: Silvia Russo, consultant

0039 90 22155

silvia_ergy@hotmail.com

Locations

Italy
Azienda Policlinico Universitario, G. Martino	Recruiting
Messina, Italy, 090
Contact: Silvia Russo, consultant

Sponsors and Collaborators

University of Messina

Investigators

Principal Investigator:

Rosario D'Anna, professor

University of Messina, Italy

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

Marini H, Minutoli L, Polito F, Bitto A, Altavilla D, Atteritano M, Gaudio A, Mazzaferro S, Frisina A, Frisina N, Lubrano C, Bonaiuto M, D'Anna R, Cannata ML, Corrado F, Adamo EB, Wilson S, Squadrito F. Effects of the phytoestrogen genistein on bone metabolism in osteopenic postmenopausal women: a randomized trial. Ann Intern Med. 2007 Jun 19;146(12):839-47.

D'Anna R, Cannata ML, Atteritano M, Cancellieri F, Corrado F, Baviera G, Triolo O, Antico F, Gaudio A, Frisina N, Bitto A, Polito F, Minutoli L, Altavilla D, Marini H, Squadrito F. Effects of the phytoestrogen genistein on hot flushes, endometrium, and vaginal epithelium in postmenopausal women: a 1-year randomized, double-blind, placebo-controlled study. Menopause. 2007 Jul-Aug;14(4):648-55.

Crisafulli A, Altavilla D, Squadrito G, Romeo A, Adamo EB, Marini R, Inferrera MA, Marini H, Bitto A, D'Anna R, Corrado F, Bartolone S, Frisina N, Squadrito F. Effects of the phytoestrogen genistein on the circulating soluble receptor activator of nuclear factor kappaB ligand-osteoprotegerin system in early postmenopausal women. J Clin Endocrinol Metab. 2004 Jan;89(1):188-92.

Morabito N, Crisafulli A, Vergara C, Gaudio A, Lasco A, Frisina N, D'Anna R, Corrado F, Pizzoleo MA, Cincotta M, Altavilla D, Ientile R, Squadrito F. Effects of genistein and hormone-replacement therapy on bone loss in early postmenopausal women: a randomized double-blind placebo-controlled study. J Bone Miner Res. 2002 Oct;17(10):1904-12.

Responsible Party:	University of Messina ( Rosario D'Anna, associate professor )
Study ID Numbers:	RODA-12254
Study First Received:	October 9, 2007
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00541710 History of Changes
Health Authority:	Italy: Ethics Committee

Keywords provided by University of Messina:

menopause
genistein
osteopenia
osteoporosis
prevention

Additional relevant MeSH terms:

Anticarcinogenic Agents
Estrogens
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Osteoporosis
Enzyme Inhibitors
Bone Diseases, Metabolic
Protein Kinase Inhibitors

Protective Agents
Bone Diseases
Hormones
Pharmacologic Actions
Musculoskeletal Diseases
Estrogens, Non-Steroidal
Therapeutic Uses
Osteoporosis, Postmenopausal
Phytoestrogens
Genistein

ClinicalTrials.gov processed this record on February 08, 2010