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

A Randomized, Open label, Parallel group clinical study comparing the relative bioavailability, safety and efficacy of Microcore NESC® with Calcium carbonate and Calcium citrate malate in osteopenic and osteoporotic patients.

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/02/049901

Enrollment

Registered

2023-02-20

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Microcore NESC® Tablet: Two Tablet orally, daily for 12 weeks Control Intervention1: Shelcal and CCM: two Tablet daily, orally for 12 weeks.

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1.To monitor the Bone Mineral density (BMD)- Baseline and at 12 weeks 2.Serum Calcium test for relative absorption and bioavailability. 3.Serum Osteocalcin - 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 5.Change from baseline to 12 weeks in knee / body pain intensity measured by Pain VAS Scale (0-100mm) 6.Changes from baseline to 12 weeks in Quality of life-Questionnaires (Short Form Health-36). Timepoint: Baseline and at 12 weeks	—

Measure

Time frame

1.To monitor the Bone Mineral density (BMD)- Baseline and at 12 weeks 2.Serum Calcium test for relative absorption and bioavailability. 3.Serum Osteocalcin - 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 5.Change from baseline to 12 weeks in knee / body pain intensity measured by Pain VAS Scale (0-100mm) 6.Changes from baseline to 12 weeks in Quality of life-Questionnaires (Short Form Health-36). Timepoint: Baseline and at 12 weeks

—

Secondary

Measure	Time frame
To monitor for any adverse eventsTimepoint: Baseline upto 12 weeks	—

Countries

India

Contacts

Public ContactDr Gayathri

MGMC&RI

krishnagopalr@mgmcri.ac.in9442244864

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026