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

Phase 3

Completed

• Conditions: Age-related osteoporosis without current pathological fracture,

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

Brief Summary

Ø The subjects who fulfilled theinclusion and exclusion criteria will be enrolled in the study.

Ø 60 Participants will be randomizedinto 3 groups with 20 in each group.

Ø Arm 1 - Participants withOsteopenia and Osteoporosis will take two Tablet daily of Microcore NESC®orally for 12 weeks

Ø Arm 2 - Participants withOsteopenia and Osteoporosis will take two Tablet daily of Shellcal orally for12 weeks

Ø Arm 3 - Participants withOsteopenia and Osteoporosis will take two Tablet daily of CCM   orally for 12 weeks

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-01-10
• Study Start: 2023-02-20
• Last Update Posted: 2023-04-10

Recruitment & Eligibility

• Status: Completed
• Sex: All
• 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	Baseline and at 12 weeks
2.Serum Calcium test for relative absorption and bioavailability.	Baseline and at 12 weeks
3.Serum Osteocalcin - Baseline and at 12 weeks	Baseline and at 12 weeks
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	Baseline and at 12 weeks
5.Change from baseline to 12 weeks in knee / body pain intensity measured by Pain VAS Scale (0-100mm)	Baseline and at 12 weeks
6.Changes from baseline to 12 weeks in Quality of life-Questionnaires (Short Form Health-36).	Baseline and at 12 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mahatma Gandhi Medical College and Research Institute; 🇮🇳 Pondicherry, PONDICHERRY, India

Mahatma Gandhi Medical College and Research Institute

🇮🇳Pondicherry, PONDICHERRY, India

DrUmaN

Principal investigator

9842329417

numalally@gmail.com