NCT04739592

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4 knee-osteoarthritis

Timeline
Completed

Started Jul 2021

Longer than P75 for phase_4 knee-osteoarthritis

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

July 7, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

April 22, 2022

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

January 13, 2021

Last Update Submit

April 21, 2022

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

  • WORMS score of knee joint MRI

    WORM score of participants at the sixth month after enrollment

    The sixth month

  • WORMS score of knee joint MRI

    WORM score of participants at the 12th month after enrollment

    The 12th month

Secondary Outcomes (17)

  • WORMS score of knee joint MRI

    The 24th month

  • Pain intensity and symptom record

    The second week

  • Pain intensity and symptom record

    The 4th week

  • Pain intensity and symptom record

    The 8th week

  • Pain intensity and symptom record

    The 12th week

  • +12 more secondary outcomes

Study Arms (2)

alendronate sodium vitamin D3 tablets

EXPERIMENTAL

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

Drug: alendronate sodium vitamin D3 tablets

placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

alendronate sodium vitamin D3 tabletsDRUG

once per week for one year

alendronate sodium vitamin D3 tablets
PlaceboDRUG

once per week for one year

placebo

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

The Third Affiliated Hospital of Southern Medical University

Guangzhou, China

RECRUITING

Zhongshan Hospital

Shanghai, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35715774DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Huiming Peng

CONTACT

13601276089penghuiming@139.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2021

First Posted

February 4, 2021

Study Start

July 7, 2021

Primary Completion

July 1, 2023

Study Completion

July 1, 2024

Last Updated

April 22, 2022

Record last verified: 2021-09

Locations

CN(3)