Health Condition 1: L989- Disorder of the skin and subcutaneous tissue, unspecified
Conditions
Interventions
Intervention1: Bio-D3 Plus: Calcitriol 0.25 mcg + Elemental calcium 200 mg Capsule_2 times_84 days
Control Intervention1: Shelcal: Calcium 500 mg + Vitamin D3 250_2times_84 days
Sponsors
Dr Pravin Markade
Eligibility
Inclusion criteria
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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in bone mineral density at lumbar spine from baseline to Day 85 in both treatment groups Change in a 0-100 mm visual analogue scale score from baseline to Day 85 in both treatment groups Timepoint: day 85 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Timepoint: day 85 | — |
Countries
India
Contacts
Public ContactDr Pravin Markade
Ishwar Health Institute care
Outcome results
None listed