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Strontium Ranelate and KOA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03937518
Recruitment Status : Completed
First Posted : May 3, 2019
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Mansoura University

Brief Summary:

The present study was carried out on thirty patients with primary knee osteoarthritis. Patients were recruited from Rheumatology and Rehabilitation

Outpatient Clinic at Mansoura University Hospi Patients were divided into two groups:

Group 1: included 15 patients who received oral strontium ranelate and physiotherapy program. The age of the patients ranged from 50 to 62 years, they were 11 females and 4 males. Group 2: included 15 patients who received physiotherapy program. The age of the patients ranged from 50 to 62 years, they were 12 females and 3 males. Written consent was obtained from each participant sharing in the study. This study was approved by the institution research board of faculty of medicine, Mansoura University, code: MS/15.10.08. Inclusion


Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: Strontium Ranelate Other: physiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Strontium Ranelate as New Modality in Treatment of Primary Knee Osteoarthritis
Actual Study Start Date : July 1, 2018
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
strontium ranelate
included 15 patients who received oral strontium ranelate and physiotherapy program. The age of the patients ranged from 50 to 62 years,
Drug: Strontium Ranelate

Patients received strontium ranelate 2gm (one sachet daily with 50 ml water at bedtime at least 2 h after food), as the compliance of patient assessed by counting number of sachet that patient returns at every visit and safety is assessed by recording adverse effects as blood pressure and heart rate every visit and patients received physiotherapy program in the form of (US therapeutic acoustic radiation and exercise program) 3 times per week for 6 months.

Ultra sound (US):

Pulsed ultrasonic waves were delivered at a 1 MHz frequency and at an intensity of 1 watt/ cm2 via a transducer with a diameter of 5 cm and effective radiating area of 3.5 to 5cm² for 9.5 min (


Other: physiotherapy

Ultra sound (US):

Pulsed ultrasonic waves were delivered at a 1 MHz frequency and at an intensity of 1 watt/ cm2 via a transducer with a diameter of 5 cm and effective radiating area of 3.5 to 5cm² for 9.5 min (Medserve, England) (Huang et al., 2001). Patients were positioned in a supine position with the affected knee flexed at 90° and the sound head was held stationary over the tibiofemoral joint medial to the patellar tendon to enhance energy penetration into the joint space (White et al., 2007).

Exercise program:

The subjects were treated with a group-exercise program composed of a range of motion of all lower limb and 45 min strengthening exercises with 5 min stretching exercises of lower limb muscles 3 times per week under the supervision of the same physiatrist (Fitzgerald and Oatis


physiotherapy
included 15 patients who received physiotherapy program. The age of the patients ranged from 50 to 62 years
Other: physiotherapy

Ultra sound (US):

Pulsed ultrasonic waves were delivered at a 1 MHz frequency and at an intensity of 1 watt/ cm2 via a transducer with a diameter of 5 cm and effective radiating area of 3.5 to 5cm² for 9.5 min (Medserve, England) (Huang et al., 2001). Patients were positioned in a supine position with the affected knee flexed at 90° and the sound head was held stationary over the tibiofemoral joint medial to the patellar tendon to enhance energy penetration into the joint space (White et al., 2007).

Exercise program:

The subjects were treated with a group-exercise program composed of a range of motion of all lower limb and 45 min strengthening exercises with 5 min stretching exercises of lower limb muscles 3 times per week under the supervision of the same physiatrist (Fitzgerald and Oatis





Primary Outcome Measures :
  1. change of pain from base line [ Time Frame: immediately before intervention,3 monthes after intervention,6 monthes after intervention ]
    VAS pain is a uni-dimensional tool used to measure pain intensity. It is a 10 cm horizontal line marked every 1 cm. Pain intensity ranges from 0 (no pain, the left end of the line) to 10 (worst possible pain, the right end of the line). The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5- 44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)


Secondary Outcome Measures :
  1. change of function from base line [ Time Frame: immediately before intervention,3 monthes after intervention,6 monthes after intervention ]
    Patients were assessed before treatment, at 3rd and 6th month after treatment using Western Ontario and McMaster Universities OA index (WOMAC). WOMAC is a self-administered composite questionnaire with three components to assess pain, knee stiffness and difficulty in the activity of daily living. Its first section contains 5 questions about pain, the second section includes 2 questions which assess knee stiffness and the last section is formed of 17 questions that measure the difficulty in the activity of daily living performance.

  2. change of MRI findings from base line [ Time Frame: immediately before intervention and 6 monthes after intervention ]
    Assessment of knee joint by using semi-quantitative MRI by (MOAKS) MRI Osteoarthritis knee score which is performed



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Ages Eligible for Study:   50 Years to 62 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients aged ≥ 40 years with symptoms of knee osteoarthritis

Exclusion Criteria:

rheumatoid arthritis, spondyloarthropathy


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937518


Locations
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Egypt
Mansoura Uninersity Faculty of Medicine
Mansoura, Dakahlia Provence, Egypt, 050
Sponsors and Collaborators
Mansoura University
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Responsible Party: Mansoura University
ClinicalTrials.gov Identifier: NCT03937518    
Other Study ID Numbers: MS 15.09.44
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Strontium ranelate
Bone Density Conservation Agents
Physiological Effects of Drugs