To study the effects of CollagenCal? in the management of Osteoporosis in women.
- Conditions
- Health Condition 1: M810- Age-related osteoporosis without current pathological fracture
- Registration Number
- CTRI/2012/05/002631
- Lead Sponsor
- itta Gelatin India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Subjects whoare ambulatory women of 40 to 65 years oldWhoare willing to give informed consent
Whoare willing to comply with the study procedures and restrictions
are diagnosed by DEXA as osteoporotic, with BMD score of T < -2.5 in Lumbar Spine (L1-L4) and/or Total Hip [WHO Diagnostic Criteria for Osteoporosis]
are diagnosed with Primary osteoporosis
?Subjects who are previously diagnosed with secondary osteoporosis or got presently diagnosed by clinical lab investigations.
?Subject who are having a BMI of more than 30
?had or has fracture, as observed from medical history with in past 6 months.
?Subjects who had hysterectomy
?Subjects who had received glucocorticoids, estrogens, thyroid hormone, parathyroid hormone, fluoride, bisphosphonates, calcitonin, thiazide diuretics, barbiturates, antiepileptic medication for the past 3 months.
?Subjects who are suffering from systemic diseases (cardiac, hepatic, renal, hemopoietic) which the investigator feels will compromise the subject?s safety.
?Subjects who are suffering from disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
?Pregnant, lactating women and women of child bearing potential, not practicing effective methods of contraception and planning a pregnancy during the study period.
?Subjects who are known to have or tested positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B surface antigen
?Any other metabolic bone disease or secondary cause to bone loss that is not controlled and will interfere with the interpretation of the findings.
?Malignancy
?Subjects who had or has received any organ or bone marrow transplantation.
?Any laboratory abnormality which, in the opinion of the investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results.
?Subjects who are known to have calcium intolerance.
?Any physical or psychiatric disorder which, in the opinion of the investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results.
?Alcohol or substance-abuse or smoking within the last 3 months.
?Subjects who recently underwent gastro-intestinal contrast studies and/or radionuclide tests before one week.
?Subjects who are having serum Creatinine1.3mg/dL, Serum calcium 10 mgl/dL.
?Subjects who are having systolic BP 175 mm Hg or diastolic BP 105mm Hg.
?Subject?s who are in suspect of primary hyperparathyroidism with serum calcium 10mg/dL combined with PTH 5.0 mmol/L or serum calcium 9.8mg/dL combined with PTH ≥7.0 mmol/L.
?Subjects who used Ayurvedic formulation or any form of CAM (Complementary Alternative Medicine) therapy in the preceding 3 months
?Subjects who are currently enrolled or participated in the any other trial(s) in preceding 3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage decrease in the following markers from baseline to end of Treatment period <br/ ><br>oSerum â?? CTx: 23- 35% <br/ ><br>oSerum OC and Serum BAP : 13- 20% <br/ ><br>oFree Urinary DPD : 13 - 20% <br/ ><br>Timepoint: Percentage Decrease in the following Markers from Baseline to 6months and End of Treatment <br/ ><br>oSerum â?? CTx: 23- 35% <br/ ><br>oSerum OC and Serum BAP : 13- 20% <br/ ><br>oFree Urinary DPD : 13 - 20% <br/ ><br>
- Secondary Outcome Measures
Name Time Method â?¢Increase in percentage of BMD from baseline to the end of treatment Period <br/ ><br>â?¢Improvement in QoL from baseline to the end of treatment Period <br/ ><br>Timepoint: Base Line and End of study which is after one year <br/ ><br>