A clinical study to assess the improvement of bone mass and safety of the test product

Not yet recruiting

• Conditions: Low bone mass

• Registration Number: CTRI/2020/03/023713
• Lead Sponsor: ITC Life Sciences and Technology Centre

Brief Summary

This is a double blind, randomized (1:1:1), placebo controlled, parallel group, three-arm study. Subjects meeting all inclusion and no exclusion criteria after signing a written informed consent will be enrolled in the study. After passing the eligibility criteria, subjects will be randomized into 3 treatment arms to receive Test Product 1, Test Product 2 or Placebo. The investigation products (IPs) will be administered once a day (single dose of randomized IP half an hour after breakfast in the morning) for 6 months. The efficacy of the IP’s will be assessed by dual-energy X-ray absorptiometry (DEXA) scan, and based on markers for bone formation , bone resorption ,joint health and Inflammation.Serum levels of calcium, phosphorus and vitamin D also will be assessed. , Questionnaire based assessment will be  used to assess the impact on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Quality of life will be assessed by SF-12 questionnaire. The safety and tolerability of the IP’s will be assessed by evaluation of incidences of adverse events reported

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Subjects with low bone mass (BMD, T- score of -1 to -2.5 SD) 2.
• Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.

Exclusion Criteria

• History of any illness affecting bone metabolism like renal failure, hepatic failure, active malignancy, hyperthyroidism or hyper parathyroidism 2.
• Pregnant or lactating women.
• Female patient of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study treatment and for 4 weeks after the end of treatment.
• Subjects with Alkaline phosphatase more than twice the upper limit of normal, Liver disease (SGOT or SGPT more than twice the upper limit of normal),Kidney disease (creatinine >2.0 mg/dL) Hypercalcemia (calcium >10.5 mg/dL) 5.
• Uncontrolled chronic disorders that could affect bone metabolism (liver disease, alcoholism, primary hyperparathyroidism, or malignancy) 6.
• Pharmacotherapy for osteoporosis (except calcium or vitamin D) in the previous 3 months 7.
• Injection of an agent for osteoporosis in the previous 6 months 8.
• Systemic administration of an agent that may affect calcium metabolism in bone, such as a systemic corticosteroid or diuretic, for more than 6 months (subjects who have not received forbidden drugs except contraceptive injections within the previous 3 months before screening may be eligible to participate) 9.
• Metabolic bone diseases other than osteoporosis 10.
• A mental disorder likely to affect compliance with the requirements of the trial 11.
• Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study 12.
• Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Bone mass, Bone Resorption and bone formation markers	Day 0, Day 90, Day 180

Secondary Outcome Measures

Name	Time	Method
Changes in Serum levels of calcium, phosphorus and vitamin D	Day 0, Day 90, Day 180
Changes in Questionnaire based Assessments	Day 0, Day 90, Day 180
change in Joint Health and Inflammatory markers	Day 0, Day 90, Day 180

Trial Locations

Locations (1)

Medistar Hospital; 🇮🇳 Vadodara, GUJARAT, India

Medistar Hospital

🇮🇳Vadodara, GUJARAT, India

Dr Tanmay Banerjee

Principal investigator

tanmay_ortho@yahoo.com