- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03937518
Strontium Ranelate and KOA
Strontium Ranelate as New Modality in Treatment of Primary Knee Osteoarthritis
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
InclusionAll patients were subjected to the following:
I. History Taking :
Personal History
- Name, age, sex, residence, marital status.
- Occupational status.
- Special habits e.g. smoking status (current/previous).
Complaint:
Taken in the patient's own words with special stress on disease duration.
Present history:
Onset, course and duration of disease. Analysis of complaint Pain: type of pain, site of pain, factors participating/alleviating pain. Swelling. Crepitus. Limitation of movement. Morning and inactivity stiffness, its duration and location. Other joints affected and its pattern of distribution.
History of other systems affections:
Neurological symptoms (muscle power and sensation of the lower limbs). Eye symptoms (redness, ulcers and blurred vision). Gastrointestinal tract (GIT) symptoms (diarrhea, heart burn and mucus in the stool). Urinary tract (UT) symptoms (dysuria and frequency). Skin affection (ulcers, erythema, papules and nodules).
- Past history:
History of surgical operation of knee.
HistoryAssessment of range of motion of the affected knee joint:
For any limitation in the range of motion of the knee joint.
D) Special tests to assess ligaments and menisci:
Varus stress test for lateral collateral ligament. Valgus stress test for medial collateral ligament. Anterior drawer test for anterior cruciate ligament. Posterior drawer test for posterior cruciate ligament.
McMurry's test for menisci.Radiological investigations:
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Dakahlia Provence
-
Mansoura, Dakahlia Provence, Egypt, 050
- Mansoura Uninersity Faculty of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients aged ≥ 40 years with symptoms of knee osteoarthritis
Exclusion Criteria:
rheumatoid arthritis, spondyloarthropathy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: strontium ranelate
included 15 patients who received oral strontium ranelate and physiotherapy program.
The age of the patients ranged from 50 to 62 years,
|
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 ( 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 |
Other: physiotherapy
included 15 patients who received physiotherapy program.
The age of the patients ranged from 50 to 62 years
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
immediately before intervention,3 monthes after intervention,6 monthes after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
immediately before intervention,3 monthes after intervention,6 monthes after intervention
|
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
|
immediately before intervention and 6 monthes after intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MS 15.09.44
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Knee Osteoarthritis
-
LifeBridge HealthMicroPort Orthopedics Inc.; Rubin Institute for Advanced OrthopedicsRecruitingKnee Osteoarthritis | Osteoarthritis, Knee | Knee Pain Chronic | Arthropathy of Knee Joint | Knee Disease | Osteoarthritis Knees Both | Osteoarthritis Knee Left | Osteoarthritis Knee RightUnited States
-
University Hospital, Clermont-FerrandSanofiCompletedKnee Osteoarthritis (Knee OA)France
-
Joseph E. BroylesCompletedDegenerative Lesion of Articular Cartilage of Knee | Degeneration; Articular Cartilage, Knee | Unilateral Primary Osteoarthritis of Knee | Osteoarthritis Knee
-
Jiangsu XinChen-Techfields Pharma Co., LTD.Completed
-
The Hong Kong Polytechnic UniversityCompleted
-
Federal University of São PauloCompletedKNEE OSTEOARTHRITISBrazil
-
Novartis PharmaceuticalsRecruitingSymptomatic Knee OsteoarthritisUnited States, Spain, Hungary, Argentina, Germany, Slovakia, Czechia, Belgium, Romania
-
University of BathUniversity of Oxford; 3D Metal Printing Ltd; Versus ArthritisRecruitingMedial Knee OsteoarthritisUnited Kingdom
-
Max Biocare Pty. Ltd.Completed
Clinical Trials on Strontium Ranelate
-
Aga Khan University Hospital, PakistanAO Trauma Middle East and North AfricaRecruitingClinical Trial | Fragility Fracture | Femur; Fracture, PertrochantericPakistan
-
Medical University of ViennaNational Bank of AustriaCompletedPrimary Hyperparathyroidism | Osteoporosis | OsteopeniaAustria
-
NycomedCompleted
-
Eli Lilly and CompanyCompletedPostmenopausal OsteoporosisGermany, Spain, Greece, Mexico, Israel, Czech Republic
-
University of ValenciaCompletedPostmenopausal Osteoporosis | ComplianceSpain
-
Peking Union Medical College HospitalNot yet recruitingBone Metastases | Thyroid Neoplasm FollicularChina
-
Sun Yat-sen UniversityCompletedDentine HypersensitivityChina
-
European Organisation for Research and Treatment...CompletedProstate Cancer | Metastatic CancerNetherlands, Denmark, Belgium, Poland, Switzerland, United Kingdom, Italy, Russian Federation, Portugal
-
BioLink Life Sciences, Inc.Biofortis Innovation Services, a division of Merieux Nutrisciences, Inc.; NMS...CompletedOsteopenia | Osteoporosis, Postmenopausal | Low Bone DensityUnited States
-
Smerud Medical Research International ASSantoSolve ASUnknownPain | OsteoarthritisUnited Kingdom, Finland, Poland, Russian Federation