A study of vitamin K2-7 in Osteoporosis
- Conditions
- Health Condition 1: M818- Other osteoporosis without currentpathological fracture
- Registration Number
- CTRI/2020/04/024684
- Lead Sponsor
- SSV Phytopharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1.Men and non-pregnant women who are at least 20 years and under 75 years of age; and
2.The osteoporosis diagnosed by standard DXA measurement (BMD T-score: - 2.5 or below); and
3.Pain defined by a level of greater than or equal to 4 on Visual Analogue Scale (VAS).
4. Patients who are, in the opinion of the Investigator, able to comply with the requirements of the study; and
5.Patients who have been adequately informed of the nature and risks of the study and who have given written informed consent prior to receiving study medication.
1.Women who are pregnant, as determined by a urine pregnancy test, or breast-feeding.
2.Presence or history of congestive heart failure (NYHA class III/IV) within the prior 12 weeks.
3.Recent myocardial infarction (within the prior 12 weeks).
4.Unstable angina pectoris.
5.Known or suspected renal insufficiency defined as creatinine >1.5mg/dl.
6.Known or suspected hepatic insufficiency defined as abnormal liver function tests (GOT/GPT) >3x upper normal limit (i.e., 120 U/l).
7.Known hypomotility syndrome: (such as hypothyroidism or scleroderma).
8.Recent major trauma within the prior 12 weeks.
9.Recent surgery requiring anesthesia including coronary artery bypass graft (within 12 weeks).
10.Recent hospitalization (within 12 weeks)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in Pain Score on the basis of Visual Analog Scale (VAS)Timepoint: 30 days
- Secondary Outcome Measures
Name Time Method Safety and EfficacyTimepoint: 30 days