NCT01219140

Brief Summary

Treatment of post-menopausal subjects (with decreased bone mineral density) with pomegranate extract capsules will produce statistically significant changes in biomarkers for bone resorption and formation when compared to subjects receiving placebo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 13, 2010

Completed
Last Updated

October 13, 2010

Status Verified

October 1, 2010

Enrollment Period

5 months

First QC Date

October 8, 2010

Last Update Submit

October 8, 2010

Conditions

Osteopenic Women

Keywords

POMxOsteopeniapostmenopausal womenPomegranate

Outcome Measures

Primary Outcomes (1)

  • Biomarkers

    To evaluate the impact of pomegranate extract capsules on urinary N-terminal telopeptide (NTX) and serum procollagen type 1 amino-terminal propeptide (P1NP), in post-menopausal women with decreased bone mineral density

    Throughout study

Secondary Outcomes (1)

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Throughout study

Study Arms (2)

2 POMx Capsules

EXPERIMENTAL

2 POMx Capsules daily

Dietary Supplement: 2 POMx Capsules

2 placebo Capsules

PLACEBO COMPARATOR

2 placebo Capsules daily

Dietary Supplement: 2 placebo Capsules

Interventions

2 POMx CapsulesDIETARY_SUPPLEMENT

2 POMx Capsules daily

2 POMx Capsules
2 placebo CapsulesDIETARY_SUPPLEMENT

2 placebo Capsules daily

2 placebo Capsules

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal women (having had their last menstrual period within the past 15 years and an appropriate serum FSH value) 45-65 years of age;
  • The subject must have a T score of -1 to -2.5 at the lumbar spine or proximal femur;
  • All clinical safety laboratory values at screening and randomization must be either within the reference range or be determined by the investigator and the sponsor to be abnormal, but not clinically significant;
  • The patient must have provided written informed consent.

You may not qualify if:

  • The subject has any of the following conditions: connective tissue disease, history of clinically significant renal, hepatic pulmonary, cardiovascular, cerebrovascular, gastrointestinal, metabolic, hematological, endocrinological, urological, immunological, neurologic or psychiatric disorders, unless approved by the sponsor on a case by case basis;
  • The subject has a positive test result for Hepatitis B surface antigen or antibody to hepatitis C virus at Screening;
  • The subject has a known history of infection with the human immunodeficiency virus (HIV); -
  • The subject has used bisphosphonate or fluoride therapy within the past 12 or 24 months, respectively;
  • The subject has used denosumab within the past 24 months;
  • The subject has used tibolone, parathyroid hormone (or any of its derivatives), systemic glucocorticoids or inhaled glucocorticoids, anabolic steroids or testosterone within the past 6 months;
  • The subject has used estrogens, selective estrogen receptor modulators, calcitonin or calcitriol within the past 3 months;
  • The subject has hyperparathyroidism, hypoparathyroidsim, hyperthyroidism, hypothyroidism, hypocalcemia, rheumatoid arthritis, paget's disease of bone, osteomalacia;
  • The subject has had a bone fracture within the past year;
  • The subject has acute or chronic disease requiring frequent changes in medications or dosages of chronic therapy;
  • A history of alcoholism within the last 2 years or a current history of imbibing 3 or more units of alcohol per day. (1 unit is equivalent to 1 glass of wine, 1 pint of beer, or 1 shot of hard liquor);
  • The subject has participated in another study with an investigational drug or device during the 30 days prior to study entry;
  • The subject has a condition interfering with his ability to provide informed consent or comply with study instructions, or the patient has a condition, which might confound the interpretation of the study result;
  • The subject has a condition endangering herself if she were to participate in this trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SeaView Research, Inc.

Miami, Florida, 33126, United States

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 8, 2010

First Posted

October 13, 2010

Study Start

May 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

October 13, 2010

Record last verified: 2010-10

Locations

US(1)