To Evaluate the Efficacy and Safety of Bio-D3® Plus Vs Shelcal® of Patients with Osteoporosis of lumber spine

Phase 4

Not yet recruiting

• Conditions: Health Condition 1: L989- Disorder of the skin and subcutaneous tissue, unspecified

• Registration Number: CTRI/2020/10/028767
• Lead Sponsor: Dr Pravin Markade

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Adult male or female patients aged between 18 to 65 years of age (both ages inclusive).

2.Patients diagnosed by DXA as osteoporotic, with BMD score of T <-2.5 in lumbar spine.

3.Patients with inadequate levels of Calcium/Calcitriol in the opinion of investigator requiring study treatment.

4.Patients willing to use only oral Acetaminophen/Paracetamol (less than or equal to 4 g per day) for aches and pains experienced during the trial.

5.Women of childbearing potential must be willing to consistently use an appropriate method of contraception.

6.Willingness to give their written informed consent to participate in the study.

7.Patients willing to comply with all aspects of the protocol.

Exclusion Criteria

1.Patients who have known history of other bone/metabolic disease (e.g. osteomalacia or osteogenesis imperfecta) and liver cirrhosis.

2.Patients who have unstable liver disease (as defined by the known history of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbertâ??s syndrome or asymptomatic gallstones).

3.Patients have history of malabsorption syndrome or any gastrointestinal disorders associated with malabsorption.

4.Patients with osteomyelitis or osteonecrosis.

5.Patient has a history or evidence of lumbar fracture.

6.Patients who are known to have history of calcium intolerance.

7.Patients who are receiving Ayurvedic, Unani, Herbal, and Homeopathy therapy as stable dose in the past 3 months from screening for treatment of osteoporosis.

8.Patients with a known history of hypersensitivity to any of the active or inactive ingredients of the investigational products.

9.Patients with history of hypercalcemia, hypercalciuria, or active kidney stone disease.

10.Patients receiving glucocorticoids, estrogens, thyroid hormone, parathyroid hormone, fluoride, bisphosphonates, calcitonin, thiazide diuretics, barbiturates, or antiepileptic medications in the past 3 months from screening.

11.Patients with known history of fracture in the past 6 months from screening.

12.Patients with known history of malignancy

13.Patients who received any organ or bone marrow transplantation.

14.Any clinical abnormality which, in the opinion of the investigator, will prevent the patient from completing the study or interfere with the interpretation of the study results.

Study & Design

• Study Type: PMS
• Study Design: Not specified