A clinical Study to understand the effects and safety profile of Test drug [Ingredients - Calcium Carbonate, Calcitriol, Magnesium, Soy Isoflavones, and Vitamin K2-7] versus Comparator drug [Ingredients - Calcium Carbonate, Calcitriol and Zinc] in Postmenopausal Women with Osteoporosis.
- Conditions
- Health Condition 1: M810- Age-related osteoporosis without current pathological fracture
- Registration Number
- CTRI/2022/07/043913
- Lead Sponsor
- Dr Hrishikesh Patkar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Post Menopausal women upto 65 years of age who are diagnosed with osteoporosis.
a. Postmenopausal status defined as no vaginal bleeding or spotting for at least 12 consecutive months prior to screening without an alternative medical cause
b. Osteoporosis as diagnosed by BMD T-score less than or equal to â??2.50 at the lumbar spine (L1-L4) by DXA
2.Patients who require test Product or active comparator for their treatment of osteoporosis as per investigator discretion
3.Patients willing to give their written informed consent to participate in the study
4.Patients willing to comply with all aspects of the protocol
1. Patients with known hypersensitivity to any of the study treatment ingredient
2. Vitamin D deficiency as indicated by serum levels of 25-hydroxyvitamin D test, Vitamin D <10 ng/mL at screening.
3. Malabsorption syndrome or any gastrointestinal disorders that are associated with malabsorption
4. Patients with history of hip replacement
5. Patients with history of any metabolic bone disease, e.g., osteomalacia or osteogenesis imperfecta, Pagetâ??s disease, Cushingâ??s disease, or hyperprolactinemia
Patients with history of severe, untreated hypocalcaemia or hypercalcemia
7. Patients with current evidence of hyperparathyroidism or hypoparathyroidism
8. Patients with a history of renal calculi
9. Any clinical fracture within last 6 months prior to screening
10. Patients receiving concomitant medications such as estrogen or estrogen-related compounds, bisphosphonates, fluorides, calcitonin, or any other treatment within the previous 6 months that might have influenced bone mineralization
11. Currently receiving treatment for osteoporosis which cannot be stopped or which may interfere with study results or safety of patients participating in the study
12. Patients who received any solid organ or bone marrow transplant or on chronic immunosuppression for any reason
13. Height, weight or abdominal circumference of patient that has a potential to preclude accurate DXA measurements
14. Patients with poorly controlled hypertension or diabetes mellitus
15. Any clinically significant acute or chronic illness that could compromise the integrity of study data or affect the analyses if the disease exacerbates during the study or place the subject at risk by participating in the study
16. Patients with history of alcohol and/or drug/substance abuse and current significant alcohol consumption which as per investigator judgement make the subject, Ineligible to participate in the study.
17. Patients with hyperuremia or known history of gout and other disease related to uric acid accumulation.
18. Patients who are immobilized >6 weeks.
19. Patients who were a part of any other clinical trial during the past three months prior to screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in low back pain as assessed by visual analogue score scale Visit 5 (End of Treatment)Timepoint: Visit 1, Visit 3, Visit 4 & Visit 5 (End of Treatment)
- Secondary Outcome Measures
Name Time Method Acceptability of the study treatments based on patient acceptability questionnaireTimepoint: will be assessed throughout the study period.;Change in lumbar spine (L1-L4) BMD measurement done by dual-energy x-ray absorptiometry at Visit 5 (End of Treatment)Timepoint: Visit 1 and Visit 5;Change in menopause symptom relief score at Visit 3 as assessed by menopause rating score questionnaireTimepoint: Visit 1 and Visit 3;Change in menopause symptom relief score at Visit 4 as assessed by menopause rating score questionnaireTimepoint: Visit 1, Visit 3 & Visit 4;Change in menopause symptom relief score at Visit 5 as assessed by menopause rating score questionnaireTimepoint: Visit 1, Visit 3, Visit 4 & Visit 5 (End of Treatment);Incidence of clinical fractures during the study periodTimepoint: will be assessed throughout the study period.;Risk of fracture during the study periodTimepoint: will be assessed throughout the study period.
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