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

Not Applicable

Not yet recruiting

• Conditions: Disorder of the skin and subcutaneous tissue, unspecified,

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

Brief Summary

A Prospective, Single-center, Open label,Randomized, Parallel-group, Comparative Clinical Study to Evaluate the Efficacyand Safety of Bio-D3® Plus Vs Shelcal® in the Treatment of Patients withOsteoporosis of Lumbar Spine There are 5 scheduled study site visits during theentire study period; Visit 1 (Screening period/Up to 7 days), Visit 2(Randomization/Start of study treatment with IP), Visit 3 (Treatment period/Day43 (±2 days), Visit 4 (End of treatment [EOT]/Day 85 (±2 days) and End of study(EOS)/Telephonic safety follow-up after 7 days of last dose of IP, Individual participationof the patient in the study will last for up to 94 days. Patients willundergo screening study procedures and assessments upon signing of informedconsent form (ICF). Detailed medical/surgical, prior and concomitant medicationdetails will be asked from patients and recorded. Upon screening assessments and procedures, a totalof 60 eligible patients will be randomized in 1:1 ratio to receive treatmentfrom any one study treatment groups. Treatment A received Bio-D3 plus and treatment B received shelcal.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-11
• Last Update Posted: 2020-10-26

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

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 Gilbert’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

Primary Outcome Measures

Name	Time	Method
Percent change in bone mineral density at lumbar spine from baseline to Day 85 in both treatment groups	day 85
Change in a 0-100 mm visual analogue scale score from baseline to Day 85 in both treatment groups	day 85

Secondary Outcome Measures

Name	Time	Method
Change in a 0-100 mm visual analogue scale score from baseline to Day 43 in both treatment groups	Change in serum calcium level on Day 85 in both the treatment groups

Trial Locations

Locations (1)

Ishwar Institute of Health care; 🇮🇳 Aurangabad, MAHARASHTRA, India

Ishwar Institute of Health care

🇮🇳Aurangabad, MAHARASHTRA, India

Dr Pravin Markade

Principal investigator

9822314268

drpravin.iicr@gmail.com