se of Microcore calcium to treat age related or post menopausal Osteoporosis

Phase 3

Completed

• Conditions: Health Condition 1: M810- Age-related osteoporosis without current pathological fracture

• Registration Number: CTRI/2023/02/049901
• Lead Sponsor: Microcore Research labs, India.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-10-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1. Patients must be in the age group of 45 - 80 years of age.

2. Males or Females: Females must be non-pregnant / non-lactating and practicing adequate birth control measures if not menopausal.

3. Patients should be able to understand and signed the informed consent form after being explained by the investigator. They must be aware of the experimental nature of the therapy, its potential benefits, side effects, risks and benefits.

4. The patients with Osteopenia and Osteoporosis, diagnosed by BMD will be enrolled (Bone mineral density, T score is between -1 and - 2 is called osteopenia and T-score below- 2 indicates osteoporosis).

Exclusion Criteria

1. History or presence of significant:

- Cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrinal, immunologic, dermatologic, neurological or psychiatric disease.

2. Alcohol dependence, alcohol abuse or drug abuse within the past one year

3. Ulceration or history of gastric and / or duodenal ulcer.

4. Patients who are allergic to Investigational products

5. HIV positive or immunocompromised individuals

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To monitor the Bone Mineral density (BMD)- Baseline and at 12 weeks <br/ ><br> <br/ ><br>2.Serum Calcium test for relative absorption and bioavailability. <br/ ><br> <br/ ><br>3.Serum Osteocalcin - Baseline and at 12 weeks <br/ ><br> <br/ ><br>4.X-ray at baseline and 12 weeks to understand any fine fracture or cracks in the osteoporotic patient and its healing or regeneration after the course of medication <br/ ><br> <br/ ><br>5.Change from baseline to 12 weeks in knee / body pain intensity measured by Pain VAS Scale (0-100mm) <br/ ><br> <br/ ><br>6.Changes from baseline to 12 weeks in Quality of life-Questionnaires (Short Form Health-36). <br/ ><br>Timepoint: Baseline and at 12 weeks

Secondary Outcome Measures

Name	Time	Method
To monitor for any adverse eventsTimepoint: Baseline upto 12 weeks