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Knee OsteoarthritisPhase 4NCT04739592

A Study of Alendronate Sodium Vitamin D3 Tablets on Knee Osteoarthritis

A Phase 4 study testing alendronate sodium vitamin D3 tablets in people with Knee Osteoarthritis, run by Peking Union Medical College Hospital at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 75 years
Conditions the study is for
Knee Osteoarthritis
What is being tested?
alendronate sodium vitamin D3 tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
3 sitesChina
Study dates
7 Jul 2021to Jul 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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;
Show all 18Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country.

Huiming Peng contact

13601276089

penghuiming@139.com

China3 sites, 3 recruiting

  • Peking Union Medical College Hospital

    Beijing

    Huiming Peng, 1, penghuiming@139.com

    Recruiting

  • The Third Affiliated Hospital of Southern Medical University

    Guangzhou

    Chang Zhao, zhaochang81@126.com

    Recruiting

  • Zhongshan Hospital

    Shanghai

    Yi Yang, dlyangyi@hotmail.com

    Recruiting

Other trials in China

About this study

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.

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.

Read the 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.

Being tested
alendronate sodium vitamin D3 tablets, Placebo
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • alendronate sodium vitamin D3 tabletsDrug

    once per week for one year

  • PlaceboDrug

    once per week for one year

Study groups in NCT04739592
Study groupRoleWhat they receive
alendronate sodium vitamin D3 tabletsExperimentalparticipants will receive alendronate sodium vitamin D3 tablets once per week for one year.
Receives: Drug: alendronate sodium vitamin D3 tablets
placeboPlacebo comparatorparticipants will receive a placebo tablet once per week for one year.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. WORMS score of knee joint MRI

    WORM score of participants at the sixth month after enrollment

    Measured: The sixth month

  2. WORMS score of knee joint MRI

    WORM score of participants at the 12th month after enrollment

    Measured: The 12th month

Secondary outcomes (17)

  1. WORMS score of knee joint MRI

    WORM score of patients at the 24th month after enrollment

    Measured: The 24th month

  2. Pain intensity and symptom record

    Pain intensity and symptom record of patients at the second week after enrollment

    Measured: The second week

  3. Pain intensity and symptom record

    Pain intensity and symptom record of patients at the 4th week after enrollment

    Measured: The 4th week

  4. Pain intensity and symptom record

    Pain intensity and symptom record of patients at the 8th week after enrollment

    Measured: The 8th week

  5. Pain intensity and symptom record

    Pain intensity and symptom record of patients at the 12th week after enrollment

    Measured: The 12th week

  6. Quality of life (the MOS item short from health survey,SF-36 )

    SF-36 scale of patients at the third month after enrollment

    Measured: The third month

  7. 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

    Measured: The sixth month

  8. 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

    Measured: The 12th month

  9. bone density (lumbar spine, hip joint and knee joint)

    bone density of patients at the 12th month after enrollment

    Measured: The 12th month

  10. bone density (lumbar spine, hip joint and knee joint)

    bone density of patients at the 24th month after enrollment

    Measured: The 24th month

  11. Risk of knee replacement

    Risk of knee replacement of patients at the 12th month after enrollment

    Measured: The 12th month

  12. Risk of knee replacement

    Risk of knee replacement of patients at the 24th month after enrollment

    Measured: The 24th month

  13. 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

    Measured: The 12th month

  14. 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

    Measured: The 24th month

  15. 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.

    Measured: The third month

  16. 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.

    Measured: The sixth month

  17. 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.

    Measured: The 12th month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2021
  2. Study start7 Jul 2021
  3. Primary completionJul 2023 (estimated)
  4. Study completionJul 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04739592
Sponsor's protocol ID
Peking UMCH
Status last verified
Sep 2021
First submitted
13 Jan 2021
Last updated
22 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 35715774

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing alendronate sodium vitamin D3 tablets in people with Knee Osteoarthritis, run by Peking Union Medical College Hospital at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Huiming Peng (13601276089, penghuiming@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

WORMS score of knee joint MRI (time frame: The sixth month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04739592, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.

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