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A Study of Alendronate Sodium Vitamin D3 Tablets on Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
alendronate sodium vitamin D3 tablets
Placebo
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with significant knee pain (pain score≥40mm on the 100mmVAS scale);
  2. Male or female patients, between 50-75 years old;
  3. MRI suggests bone marrow edema-like lesions;
  4. Knee osteoarthritis (in accordance with the diagnostic criteria of American College of Rheumatology (ACR) and Chinese Orthopaedic Association);
  5. Kellgren-Lawrence gradingⅠorⅡin X-ray;

Exclusion Criteria:

  1. Other forms of active arthritis (such as rheumatoid arthritis or other inflammatory arthritis);
  2. Taken non-steroidal anti-inflammatory drugs and central analgesics (such as opioids) within two weeks;
  3. Liver function ALT or AST is 1.5 times the upper limit of normal; creatinine clearance <35ml/min;
  4. Pregnancy or suckling;
  5. Serious heart disease, endocrine, digestive, mental, nervous system diseases or cancer;
  6. Active ulcers and a history of upper gastrointestinal bleeding;
  7. Esophageal motility disorders, such as esophageal tardiness or stenosis;
  8. Renal dysfunction or osteomalacia;
  9. Tobacco addiction (mean 10 cigarettes per day or more) or/and alcohol addiction (mean 50ml per day or more);
  10. Fresh fracture in the last six months;
  11. Serious illnesses and life expectancy<2 years;
  12. Allergic to study drugs;
  13. Used any study drug or device within 30 days before randomization or within the drug half-life (whichever is longer);
  14. Failure to take medication as required;
  15. Replacement surgery in the near future;
  16. Contraindications to MRI scans (e.g. implanted pacemakers, metal sutures, shrapnel or iron filings in the eyes, claustrophobia, knees too large to use coils);
  17. Sensitive to or unsuitable for X-ray exposure (e.g. aplastic anemia, etc);
  18. Poor dental health or dental surgery in the near future.

Sites / Locations

  • Peking Union Medical College HospitalRecruiting
  • The Third Affiliated Hospital of Southern Medical UniversityRecruiting
  • Zhongshan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

alendronate sodium vitamin D3 tablets

placebo

Arm Description

participants will receive alendronate sodium vitamin D3 tablets once per week for one year.

participants will receive a placebo tablet once per week for one year.

Outcomes

Primary Outcome Measures

WORMS score of knee joint MRI
WORM score of participants at the sixth month after enrollment
WORMS score of knee joint MRI
WORM score of participants at the 12th month after enrollment

Secondary Outcome Measures

WORMS score of knee joint MRI
WORM score of patients at the 24th month after enrollment
Pain intensity and symptom record
Pain intensity and symptom record of patients at the second week after enrollment
Pain intensity and symptom record
Pain intensity and symptom record of patients at the 4th week after enrollment
Pain intensity and symptom record
Pain intensity and symptom record of patients at the 8th week after enrollment
Pain intensity and symptom record
Pain intensity and symptom record of patients at the 12th week after enrollment
Quality of life (the MOS item short from health survey,SF-36 )
SF-36 scale of patients at the third month after enrollment
Quality of life (the MOS item short from health survey,SF-36 )
SF-36 scale of patients at the sixth month after enrollment. The score is calculated from eight dimensions, with the higher the final score the better
Quality of life (the MOS item short from health survey,SF-36 )
SF-36 scale of patients at the 12th month after enrollment. The score is calculated from eight dimensions, with the higher the final score the better
bone density (lumbar spine, hip joint and knee joint)
bone density of patients at the 12th month after enrollment
bone density (lumbar spine, hip joint and knee joint)
bone density of patients at the 24th month after enrollment
Risk of knee replacement
Risk of knee replacement of patients at the 12th month after enrollment
Risk of knee replacement
Risk of knee replacement of patients at the 24th month after enrollment
Kellgren & Lawrence(KL) grading Score
KL-grading Score of patients at the 12th month after enrollment, 0 to Ⅳ, higher scores mean a worse outcome
Kellgren & Lawrence(KL) grading Score
KL-grading Score of patients at the 12th month after enrollment, 0 to Ⅳ, higher scores mean a worse outcome
Serum IL-6, TNF-a, erythrocyte sedimentation rate, C-reactive protein
Serum inflammatory factor of patients at the third month after enrollment, IL-6 and TNF-a were measured in pg/ml,erythrocyte sedimentation rate was measured in mm/h, C-reactive protein was measured in mg/dL.
Serum IL-6, TNF-a, erythrocyte sedimentation rate, C-reactive protein
Serum inflammatory factor of patients at the sixth month after enrollment, IL-6 and TNF-a were measured in pg/ml,erythrocyte sedimentation rate was measured in mm/h, C-reactive protein was measured in mg/dL.
Serum IL-6, TNF-a, erythrocyte sedimentation rate, C-reactive protein
Serum inflammatory factor of patients at the 12th month after enrollment, IL-6 and TNF-a were measured in pg/ml,erythrocyte sedimentation rate was measured in mm/h, C-reactive protein was measured in mg/dL.

Full Information

First Posted
January 13, 2021
Last Updated
April 21, 2022
Sponsor
Peking Union Medical College Hospital
Collaborators
CSPC Ouyi Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04739592
Brief Title
A Study of Alendronate Sodium Vitamin D3 Tablets on Knee Osteoarthritis
Official Title
The Effect of Alendronate Sodium Vitamin D3 Tablets on Knee Joint Structure and Knee Osteoarthritis Pain: A Multi-center, Randomized, Double-blind, Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2021 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
CSPC Ouyi Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effect of alendronate sodium vitamin D3 tablets compared with placebo on the improvement of joint structure and joint pain in participants with knee osteoarthritis. The treatment period of this study is one year and followed-up period is 2 years. The results of knee joint MRI will be evaluated by using the WORMS score.
Detailed Description
This is a multi-center, randomized, double-blind, placebo-controlled study This study is planned to commence after obtaining Ethics Committee approval. participants will be randomised to a one-year course of alendronate sodium vitamin D3 tablets or placebo. 1:1 double blinded randomisation will be undertaken. This study plans to enroll 60 participants and will be carried out in three domestic centers (Peking Union Medical College Hospital, Zhongshan Hospital and The Third Affiliated Hospital of Southern Medical University) with a follow-up period of 2 years. As the main goal of this exploratory study is to evaluate the effect of alendronate sodium vitamin D3 tablets compared with placebo on the improvement of joint structure and joint pain in participants with knee osteoarthritis. The primary outcome measure is WORMS score of knee joint MRI at 6 months and 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
alendronate sodium vitamin D3 tablets
Arm Type
Experimental
Arm Description
participants will receive alendronate sodium vitamin D3 tablets once per week for one year.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
participants will receive a placebo tablet once per week for one year.
Intervention Type
Drug
Intervention Name(s)
alendronate sodium vitamin D3 tablets
Intervention Description
once per week for one year
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
once per week for one year
Primary Outcome Measure Information:
Title
WORMS score of knee joint MRI
Description
WORM score of participants at the sixth month after enrollment
Time Frame
The sixth month
Title
WORMS score of knee joint MRI
Description
WORM score of participants at the 12th month after enrollment
Time Frame
The 12th month
Secondary Outcome Measure Information:
Title
WORMS score of knee joint MRI
Description
WORM score of patients at the 24th month after enrollment
Time Frame
The 24th month
Title
Pain intensity and symptom record
Description
Pain intensity and symptom record of patients at the second week after enrollment
Time Frame
The second week
Title
Pain intensity and symptom record
Description
Pain intensity and symptom record of patients at the 4th week after enrollment
Time Frame
The 4th week
Title
Pain intensity and symptom record
Description
Pain intensity and symptom record of patients at the 8th week after enrollment
Time Frame
The 8th week
Title
Pain intensity and symptom record
Description
Pain intensity and symptom record of patients at the 12th week after enrollment
Time Frame
The 12th week
Title
Quality of life (the MOS item short from health survey,SF-36 )
Description
SF-36 scale of patients at the third month after enrollment
Time Frame
The third month
Title
Quality of life (the MOS item short from health survey,SF-36 )
Description
SF-36 scale of patients at the sixth month after enrollment. The score is calculated from eight dimensions, with the higher the final score the better
Time Frame
The sixth month
Title
Quality of life (the MOS item short from health survey,SF-36 )
Description
SF-36 scale of patients at the 12th month after enrollment. The score is calculated from eight dimensions, with the higher the final score the better
Time Frame
The 12th month
Title
bone density (lumbar spine, hip joint and knee joint)
Description
bone density of patients at the 12th month after enrollment
Time Frame
The 12th month
Title
bone density (lumbar spine, hip joint and knee joint)
Description
bone density of patients at the 24th month after enrollment
Time Frame
The 24th month
Title
Risk of knee replacement
Description
Risk of knee replacement of patients at the 12th month after enrollment
Time Frame
The 12th month
Title
Risk of knee replacement
Description
Risk of knee replacement of patients at the 24th month after enrollment
Time Frame
The 24th month
Title
Kellgren & Lawrence(KL) grading Score
Description
KL-grading Score of patients at the 12th month after enrollment, 0 to Ⅳ, higher scores mean a worse outcome
Time Frame
The 12th month
Title
Kellgren & Lawrence(KL) grading Score
Description
KL-grading Score of patients at the 12th month after enrollment, 0 to Ⅳ, higher scores mean a worse outcome
Time Frame
The 24th month
Title
Serum IL-6, TNF-a, erythrocyte sedimentation rate, C-reactive protein
Description
Serum inflammatory factor of patients at the third month after enrollment, IL-6 and TNF-a were measured in pg/ml,erythrocyte sedimentation rate was measured in mm/h, C-reactive protein was measured in mg/dL.
Time Frame
The third month
Title
Serum IL-6, TNF-a, erythrocyte sedimentation rate, C-reactive protein
Description
Serum inflammatory factor of patients at the sixth month after enrollment, IL-6 and TNF-a were measured in pg/ml,erythrocyte sedimentation rate was measured in mm/h, C-reactive protein was measured in mg/dL.
Time Frame
The sixth month
Title
Serum IL-6, TNF-a, erythrocyte sedimentation rate, C-reactive protein
Description
Serum inflammatory factor of patients at the 12th month after enrollment, IL-6 and TNF-a were measured in pg/ml,erythrocyte sedimentation rate was measured in mm/h, C-reactive protein was measured in mg/dL.
Time Frame
The 12th month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with significant knee pain (pain score≥40mm on the 100mmVAS scale); Male or female patients, between 50-75 years old; MRI suggests bone marrow edema-like lesions; Knee osteoarthritis (in accordance with the diagnostic criteria of American College of Rheumatology (ACR) and Chinese Orthopaedic Association); Kellgren-Lawrence gradingⅠorⅡin X-ray; Exclusion Criteria: Other forms of active arthritis (such as rheumatoid arthritis or other inflammatory arthritis); Taken non-steroidal anti-inflammatory drugs and central analgesics (such as opioids) within two weeks; Liver function ALT or AST is 1.5 times the upper limit of normal; creatinine clearance <35ml/min; Pregnancy or suckling; Serious heart disease, endocrine, digestive, mental, nervous system diseases or cancer; Active ulcers and a history of upper gastrointestinal bleeding; Esophageal motility disorders, such as esophageal tardiness or stenosis; Renal dysfunction or osteomalacia; Tobacco addiction (mean 10 cigarettes per day or more) or/and alcohol addiction (mean 50ml per day or more); Fresh fracture in the last six months; Serious illnesses and life expectancy<2 years; Allergic to study drugs; Used any study drug or device within 30 days before randomization or within the drug half-life (whichever is longer); Failure to take medication as required; Replacement surgery in the near future; Contraindications to MRI scans (e.g. implanted pacemakers, metal sutures, shrapnel or iron filings in the eyes, claustrophobia, knees too large to use coils); Sensitive to or unsuitable for X-ray exposure (e.g. aplastic anemia, etc); Poor dental health or dental surgery in the near future.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huiming Peng
Phone
13601276089
Email
penghuiming@139.com
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huiming Peng
Phone
1
Email
penghuiming@139.com
Facility Name
The Third Affiliated Hospital of Southern Medical University
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang Zhao
Email
zhaochang81@126.com
Facility Name
Zhongshan Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Yang
Email
dlyangyi@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
35715774
Citation
Peng HM, Weng XS, Li Y, Feng B, Qian W, Cai DZ, Zhao C, Yao ZJ, Yang Y, Zhang C, Wan S. Effect of alendronate sodium plus vitamin D3 tablets on knee joint structure and osteoarthritis pain: a multi-center, randomized, double-blind, placebo-controlled study protocol. BMC Musculoskelet Disord. 2022 Jun 17;23(1):584. doi: 10.1186/s12891-022-05521-4.
Results Reference
derived

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A Study of Alendronate Sodium Vitamin D3 Tablets on Knee Osteoarthritis

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