A Clinical Study to Assess the Effectiveness of Centrum OstoCalcium CCM Tablet on Bone Health Parameters in India Participants with Weak Bones

A Multicenter, Prospective Study to Evaluate the Effectiveness of Centrum OstoCalcium CCM on Bone Health Parameters in Indian Participants with Osteopenia or Osteoporosis - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/07/113317

Enrollment

158

Registered

2026-07-03

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-03

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: Centrum OstoCalcium CCM Tablet: Participants will consume 2 tablets per day for 12 months. Control Intervention1: Not applicable: Not applicable

Eligibility

Inclusion criteria

Inclusion criteria: 1. Written informed consent prior to participation. 2. Participant who have been newly prescribed Centrum OstoCalcium CCM by the treating physician as part of routine clinical practice prior to study enrolment, independent of the decision to participate in the study. 3. Diagnosed with osteopenia or osteoporosis. 4. Willing to comply with study assessments and follow-up visits as per routine clinical practice.

Exclusion criteria

Exclusion criteria: 1.Presence of metabolic bone disorders other than osteopenia or osteoporosis. 2. Documented hypercalcemia or hypercalciuria at screening, or a prior history of nephrolithiasis (kidney stones). 3. Known hypersensitivity to calcium/Calcium Citrate Malate, vitamin D/D3, vitamin K2, magnesium, or any component of Centrum OstoCalcium CCM. 4. Currently taking Centrum OstoCalcium CCM. 5. Participants who are employees of the sponsor, contract research organization (CRO), or study site staff directly involved in the conduct of the study, or their immediate family members. 6. Pregnant or lactating women, as confirmed by subject self-report at screening. 7. Any condition which, in the investigator s opinion, may interfere with study participation or data interpretation.

Design outcomes

Primary

Measure	Time frame
Percentage change from baseline in lumbar spine (L1 L4) bone mineral density (BMD) measured by DEXA at 12 months.Timepoint: Baseline and Month 12	—

Secondary

Measure	Time frame
Change from baseline in serum osteocalcin levels at 6 monthsTimepoint: Baseline and Month 6;Change from baseline in BMD T-score at 12 months, measured by DEXA at the lumbar spine (L1-L4)Timepoint: Baseline and Month 12;Change from baseline in investigator administered EQ-5D-5L index score at 3, 6, and 12 months.Timepoint: Baseline and Months 3, 6 and 12	—

Countries

India

Contacts

Public ContactDr Atul Sharma

Haleon India Private Limited

atul.x.sharma@haleon.com9820801694

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026