|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ChiCTR |
|
Last refreshed on:
|
9 July 2018 |
|
Main ID: |
ChiCTR1800016968 |
|
Date of registration:
|
2018-07-05 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
A prospective study on the effect of different antiosteoporosis drugs on patients after lumbar fusion surgery
|
|
Scientific title:
|
A prospective study on the effect of different antiosteoporosis drugs on patients after lumbar fusion surgery |
|
Date of first enrolment:
|
2018-07-15 |
|
Target sample size:
|
C:40;A:40;B:40; |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://www.chictr.org.cn/showproj.aspx?proj=28803 |
|
Study type:
|
Interventional study |
|
Study design:
|
Randomized parallel controlled trial
|
|
Phase:
|
Other
|
|
|
Countries of recruitment
|
|
China
| | | | | | | |
|
Contacts
|
|
Name:
|
Le Li
|
|
Address:
|
107 Wenhua Road West, Jinan, Shandong, China
250012
|
|
Telephone:
|
+86 18560082563 |
|
Email:
|
qiluhosp_orthoplee@163.com |
|
Affiliation:
|
Qilu Hospital of Shandong University |
|
|
Name:
|
Haipeng Si
|
|
Address:
|
107 Wenhua Road West, Jinan, Shandong, China
250012
|
|
Telephone:
|
+86 18560082571 |
|
Email:
|
18560082571@163.com |
|
Affiliation:
|
Qilu Hospital of Shandong University |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: Patients of osteoporosis with lumbar spinal stenosis
Exclusion criteria: 1. Pregnant or lactating woman; 2. Patients with serious cardial, hepatic or renal disease; 3. Patients having envolved in another clinical trials; 4. Patients don't want to attend this research or observe the blind method of this research; 5. Patients unsuitable for this trial for other reasons evaluated by researchers.
Age minimum:
20
Age maximum:
80
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Osteoporosis with lumbar spinal stenosis
|
|
Intervention(s)
|
|
C:Lumbar Fusion Surgery+Basic anti-osteoporosis drugs;A:Lumbar Fusion Surgery+MenatetrenoneSoft Capsules;B:Lumbar Fusion Surgery+Teriparatide acetate;
|
|
Primary Outcome(s)
|
|
Japanese orthopeadic association score;Bone mineral density;Lumbar CT;
|
|
Secondary Outcome(s)
|
|
Visual analogue scale;The oswestry disability index;VIT-D;N-MIDOs;ß-CROSS;T-P1NP;UCOC;Lumbar X-ray;
|
|
Source(s) of Monetary Support
|
|
Nothing to declare
|
|
Ethics review
|
Status: Not approved
Approval date: 26/08/2013
Contact:
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|