A study to see if taking a soft gel capsule is safe and helps strengthen bones in people with with weak bones.

A Randomised, Double-blind, Placebo-Controlled, Clinical Study to Evaluate Efficacy and Safety of Soft Gel Capsule of Osteo Density in Subjects with Osteoporosis. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/06/112124

Enrollment

134

Registered

2026-06-08

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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: Osteo Density soft gel capsule: Once a day orally at same time with or without food for 24 weeks. Control Intervention1: Placebo Soft Gel Capsule: Once a day orally at same time with or

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects with osteoporosis. 2. Subjects who are, in the opinion of the investigator, able to comply with the requirements of the study. 3. Subjects who have been adequately informed of the nature and risks of the study and who have given written informed consent prior to receiving study medication.

Exclusion criteria

Exclusion criteria: 1. Subject who have used treatment like denosumab or any cathepsin K inhibitor, tibolone, cinacalcet, systemic oral or transdermal estrogen or selective estrogen receptor modulators (SERMs), strontium ranelate or fluoride, hormonal ablation therapy and systemic glucocorticosteroids. 2.Female subjects who are pregnant, as determined by a urine pregnancy test, or breast-feeding. 3. Subjects with history or presence of congestive heart failure (NYHA class III/IV) within the prior 12 weeks. 4.Subjects with recent myocardial infarction (within the prior 12 weeks). 5.Subjects with unstable angina pectoris. 6.Subjects with known or suspected renal insufficiency defined as creatinine greater than 1.5mg/dl. 7.Subjects with known or suspected hepatic insufficiency defined as abnormal liver function tests (AST/ALT) greater than 3x upper normal limit (i.e., 120 U/l). 8. Subjects with known hypomotility syndrome (such as hypothyroidism or scleroderma). 9. Subjects with recent major trauma within the prior 12 weeks. 10. Subjects with recent surgery requiring anesthesia including coronary artery bypass graft (within 12 weeks). 11. Subjects with recent hospitalization (within 12 weeks).

Design outcomes

Primary

Measure	Time frame
1.Change in bone mineral density (BMD).Timepoint: Screening visit, week 12 and week 24.	—

Secondary

Measure	Time frame
Change in serum calcium, osteocalcinTimepoint: Screening visit, week 12 & week 24.;Adverse events.Timepoint: Till end of study	—

Countries

India

Contacts

Public ContactDr Milan Satia

Ethicare Clinical Trial Services (OPC) Pvt. Ltd.

milansatia@ethicare-cro.com9825585119

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026