A RANDOMIZED, OPEN LABEL, MULTI-CENTER, TWO ARMS PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CollagenCal� IN COMPARISON WITH A FORMULATION CONTAINING CALCIUM + VITAMIN D3 IN THE MANAGEMENT OF OSTEOPOROSIS IN WOMEN
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Percentage decrease in the following markers from baseline to end of Treatment period
研究概览
简要总结
PROTOCOL NUMBER: AHC/ORT/011/10
STUDY TITLE: A Randomized, Open Label, Multi-center, TwoArms Parallel Group Study to Evaluate the Efficacy and Safety of CollagenCalâ„¢in Comparison with a Formulation Containing Calcium + Vitamin D3 in theManagement of Osteoporosis in Women.
SUMMARY:
· The purposeof this study was to ascertain the efficacy and safety of CollagenCal™ inimproving bone mineral density in women with osteoporosis between the ages of40 to 65 years by evaluating percentage decrease in the bone turnover markersand improvement in BMD and overall Quality of Life (QoL) of the subjects and tocompare the results with active control arm.
· Thetreatment arm received CollagenCal™ and the control arm received a formulationwith Calcium + Vitamin D3, both to be consumed once daily for a period of oneyear.
· The analysisof the efficacy data of the subjects in the treatment arm shows that theprimary objectives of percentage decreases in the Biomarkers – Serum CTX, Serum OC, and Serum BAP from baseline toend of study have been met with statistical significance. However the data fromuDPD does not show similar results. The percentage decreases in all fourbiomarkers do not show statistically significant difference in the comparativeanalysis between CollagenCalTM and the comparator.
· Similarly,CollagenCalTM shows significantimprovement in the Nutritional Score and Quality of Life improvement in thesubject over a year but fails statistically in a comparative analysis.
· The bonemineral density changes as measured by DEXA Scan show that CollagenCalTMis efficacious as evident by significant change in the L1-L4 lumbar Scores (TScore, Z Score, BMD) but baseline to end of treatment. But the Total Hip Score are found to bestatistically insignificant. Similarly, CollagenCalTM fails to showstatistically distinguishable difference in the comparative analysis of theDEXA Scan parameters with the comparator. The same results hold true when thechanges are measured from baseline to 6 months into treatment and that same midpointto end of treatment.
· Thus, theanalysis to assess the comparative efficacy of CollagenCal™ with a formulationcontaining Calcium + Vitamin D3 in the management of osteoporotic women and thecorresponding result showed that the difference between the CollagenCal™ andthe Comparator with respect to the change in certain efficacy parameters wasnot statistically significant. However, the analysis of Total NutritionalStatus Scores and Total QoL Scores, including individual assessment scores ofQoL showed that the CollagenCal™ is significantly better than the Comparator interms of improvement in the MNA Total Score, QoL Total Score and QoL IndividualAssessment Scores from baseline to end of the treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •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.
排除标准
- ••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.
结局指标
主要结局
Percentage decrease in the following markers from baseline to end of Treatment period
时间窗: Percentage Decrease in the following Markers from Baseline to 6months and End of Treatment | oSerum – CTx: 23- 35% | oSerum OC and Serum BAP : 13- 20% | oFree Urinary DPD : 13 - 20%
oSerum – CTx: 23- 35%
时间窗: Percentage Decrease in the following Markers from Baseline to 6months and End of Treatment | oSerum – CTx: 23- 35% | oSerum OC and Serum BAP : 13- 20% | oFree Urinary DPD : 13 - 20%
oSerum OC and Serum BAP : 13- 20%
时间窗: Percentage Decrease in the following Markers from Baseline to 6months and End of Treatment | oSerum – CTx: 23- 35% | oSerum OC and Serum BAP : 13- 20% | oFree Urinary DPD : 13 - 20%
oFree Urinary DPD : 13 - 20%
时间窗: Percentage Decrease in the following Markers from Baseline to 6months and End of Treatment | oSerum – CTx: 23- 35% | oSerum OC and Serum BAP : 13- 20% | oFree Urinary DPD : 13 - 20%
次要结局
- •Increase in percentage of BMD from baseline to the end of treatment Period(•Improvement in QoL from baseline to the end of treatment Period)