Effects of D-003 and Omega-3 in women with osteoporosis

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

D-003/Omega

Scientific title:

Effects of D-003 (10 mg / day) and omega-3 fatty acids on the quality of life in postmenopausal women at risk for osteoporosis

Acronym of Scientific Title:

D-003/Omega

Secondary indentifying numbers:

D-003/Omega

Issuing authority of the secondary identifying numbers:

Natural Products Center/ National Center for Scientific Researchs

Source(s) of monetary or material support:

National Center for Scientific Research BioCubaFarma Central Account

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Roberto

Midle name:

Antonio

Last name:

Puente Rodriguez

Medical Specialty :

2nd Degree Specialist in Orthopedics

Affiliation:

Surgical Medical Research Center

Postal address:

216 and 11-B, Siboney, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+53-78581000

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Research ethics committees:

Surgical Medical Research Center, November 20, 2013

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

01/10/2014

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Osteoporosis

Intervention(s):

Study Group: 2 tablets of D-003 (5 mg/d) + 1 capsule of Omega-3 (1g) by oral route to ingest once daily with food for 3 months. Control group: 2 tablets of placebo+ 1 capsule of Omega-3 (1g) by oral route to ingest once daily with food for 3 months.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Health Status Survey (Quality of Life Questionnaire Qualeffo-41. Value between 0 and 100 points) Measuring Time: At baseline, at the end of the 4, 8 and 12 weeks.

Key secondary outcomes:

Pain (qualeffo-41 questionnaire. Value between 0 and 100 points). Measuring time: At baseline, at the end of the 4, 8 and 12 weeks. Physical function (qualeffo-41 questionnaire. Value between 0 and 100 points) Measuring Time: At baseline, at the end of the 4, 8 and 12 weeks. Social function (qualeffo-41 questionnaire. Value between 0 and 100 points) Measuring Time: At baseline, at the end of the 4, 8 and 12 weeks. Health perception (qualeffo-41 questionnaire. Value between 0 and 100 points) Measuring Time: At baseline, at the end of the 4, 8 and 12 weeks. Mental function (qualeffo-41 questionnaire. Value between 0 and 100 points) Measuring Time: At baseline, at the end of the 4, 8 and 12 weeks. Physical Assessment (weight (kg), rate (beats / min), blood pressure (mm Hg)). Measuring Time: At baseline, at the end of the 4, 8 and 12 weeks. Blood chemistry parameters (total cholesterol (mmol / L), triglycerides (mmol / L), LDL-C (mmol / L), HDL-C (mmol / L)). Measuring time:. At baseline, at the end of the12 weeks. Adverse events (description (name of event), intensity (mild, moderate, severe), causality relationship (definitely related, probably related, possibly related, unrelated)) Measuring Time: At baseline, at the end of the 4, 8 and 12 weeks.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Female

Minimum age:

20 years

Maximum age:

80 years

Inclusion criteria:

1. Healthy female volunteers from common people. 2. Aged between 20 and 80 years old. 3. Surgically or naturally postmenopausal (defined as amenorrhea maintained for a period ≥ 1 year). 4. Risk of osteoporosis moderate to high according to the scale of risk 5. Which have consented to give their informed consent.

Exclusion criteria:

1. Active liver disease, Active kidney disease, diagnosed Neoplasms or thyroid dysfunction. 2. Severe high blood pressure (90 mm Hg) 3. Uncompensated diabetes mellitus (fasting glucose> 7 mmol / L) 4.Consumption of hormone replacement therapy, bisphosphonates, anabolic steroids, calcitonin, sodium fluoride or corticosteroids in the 6 months prior to inclusion 5. The following values in laboratory tests: fasting glucose> 7 mmol / L; creatinine> 130 mol / L; alanine aminotransferase (ALT) or aspartate aminotransferase (AST)> 55 IU / L 6. History of acute myocardial infarction (AMI), surgical revascularization or cerebrovascular accident (CVA) (stroke) in the 6 months prior to inclusion. 7. Subjects with normal clinical history of drug allergy or any other special condition that endanger their health and their lives during the study.

Type of population:

Adults

Type of participant:

Healthy volunteers

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Active

Study design:

Parallel

Phase:

Target sample size:

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Sarahi

Last Name:

Mendoza Castaño

Specialty:

PhD in Pharmaceutical Sciences

Affiliation:

Center of Natural Productos, National Center for Scientific Research

Postal Address:

198 / 19 and 21, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+537-2714225/2714200/2714238

Email :

sarahi.mendoza@cnic.edu.cu [1]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Rosa

Middle Name:

Maria

Last Name:

Mas Ferreiro

Specialty:

PhD in Biological sciences

Affiliation:

Center of Natural Products, National Center for Scientific Research

Postal Address:

198 / 19 and 21, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

(537)2731522

Email :

clinica@cnic.edu.cu [2]

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000184

Date of Registration in Primary Registry:

15/08/2014

Record Verification Date:

2014/08/15

Next update date:

2015/08/15

Link to the spanish version:

Click here [3]